A mobile application-based post-stroke care strategy for survivors and their caregivers for prevention and management of post-stroke complications - "Stroke Home Care:" Development and feasibility.

Objectives: In developing nations such as India, a disparity exists between the available resources for stroke rehabilitation and the substantial burden of stroke cases. Consequently, the provision of cost-effective and multidisciplinary post-stroke rehabilitation care to stroke survivors becomes of paramount importance. The utilization of mobile applications (apps) for stroke care has been on the rise, offering a personalized and pragmatic solution with the potential for wider reach in settings constrained by limited resources. To address the unmet needs in the prevention and management of post-stroke complications, we conceptualized a strategy known as a mobile application-based post-stroke care strategy for both survivors and their caregivers. Materials and Methods: The scope of the app's focus was determined based on the incidence of post-stroke complications within a prospective cohort of stroke patients, in conjunction with existing literature. An initial "web-based mobile app" prototype was crafted to align with the identified focus area. Before the development of the final app version, a feasibility study was conducted involving 30 participant dyads (comprising a patient and a caregiver). Content validity was evaluated by a panel of 20 stroke experts encompassing neurologists, nurses, physiotherapists, and psychologists. Results: The "Stroke Home Care" (SHC) mobile app was conceived as a web-based educational tool aimed at preventing and managing post-stroke complications. It seeks to train caregivers of immobile stroke patients in the administration of preventive and therapeutic care procedures, thereby potentially enhancing survivors' quality of life and alleviating caregivers' burden. The feasibility and validity studies indicated "high satisfaction" levels among most caregivers and experts (>75%), with the remainder expressing "satisfaction" and no "dissatisfaction" regarding app utilities. Stroke experts unanimously deemed the app "appropriate", with consensus on contents, video quality, video length, and voice clarity. Caregivers reported "satisfactory" user experiences, encountering no issues during app installation or operation. Suggestions from both caregivers and experts were integrated into the final app version. Conclusion: The "SHC" app represents a feasible and well-received innovation tailored for the use by caregivers of stroke survivors. Consequently, the initial feasibility of the developed app serves as a precursor to a randomized controlled clinical trial aimed at substantiating its effectiveness within the post-stroke survivor and caregiver population. Notably, within resource-constrained contexts, this app has the potential to be a pivotal tool for post-stroke care.

Establishing continuum in Transcranial Doppler characteristics of IIH, migraine and healthy controls- An exploratory study.

BACKGROUND: IIH is a severe form of headache that often has superimposed migraine and often it is very difficult to distinguish the two forms of headache. Intracranial hemodynamics is a relatively unexplored means of distinguishing between the two forms of headache. OBJECTIVES: We aimed to study intracranial flow dynamics using Transcranial Doppler in patients with IIH, migraine, and normal controls. MATERIALS AND METHODS: It was a hospital-based observational study that included 51 people with IIH, 87 people with migraine, and 101 healthy controls and all were subjected to TCD study after detailed clinical examination. RESULTS: Mean age of patients in three groups were similar with the mean age in IIH being 33.41 ± 10.75 (age in years ± SD). Vision loss was present in 66.67% of patients with IIH, and most common field defect was generalized constriction (27.5%). Neuroimaging was abnormal in 94.11% of patients of IIH with mean CSF pressure was 31.27±5.32 cm of water. Of all the TCD-measured velocities, mean flow velocity (MFV) showed a significant difference in all three groups with (p-value <0.001). The pulsatility index, both for middle cerebral arteries as well as ophthalmic arteries showed a significant difference in the three groups with the highest values in IIH patients (p-value<.001). The mean VMR in IIH (1.11±0.32) was lower than the mean VMR in migraine (1.34±0.43) as well as controls (1.49±0.46). CONCLUSION: TCD parameters like MFV and PI are useful parameters that show considerable variation and can be used to differentiate between IIH and migraine.

STENOSIS: Long-term single versus dual antiplatelet therapy in patients with ischaemic stroke due to intracranial atherosclerotic disease - a randomised trial.

Rationale: Intracranial atherosclerotic disease (ICAD) is a pathological process that causes progressive stenosis and cerebral hypoperfusion, leading to stroke occurrence and recurrence around the world. The exact duration of dual antiplatelet therapy (DAPT) for ICAD is unclear in view of long-term risk of bleeding complications. Aim: The current study aims to study the efficacy and safety of long-term DAPT (up to 12 months) in patients with ICAD. Sample size: Using 80% power and an alpha error of 5 %, presuming a 10%-15% drop-out rate, a total of 2200 patients will be recruited for the study. Methodology: This is a prospective, randomised, double-blind, placebo controlled trial. Study outcomes: The primary outcomes include recurrent ischaemic stroke (IS) or transient ischaemic attack and any intracranial haemorrhage (ICH), major or minor systemic bleeding at the end of 12 months. Secondary outcomes include composite of any stroke, myocardial infarction or death at the end of 12 months. The safety outcomes include any ICH, major or minor bleeding as defined using GUSTO (Global Use of Streptokinase and tPA for occluded Coronary Arteries) classification at the end of 12 months and 1 month after completion of the drug treatment phase. Discussion: The study will provide level I evidence on the duration of DAPT among patients with IS due to ICAD of more than or equal to 50%.

RE-OPEN: Randomised trial of biosimilar TNK versus TPA during endovascular therapy for acute ischaemic stroke due to large vessel occlusions.

Rationale: Rapid and timely treatment with intravenous thrombolysis and endovascular treatment (EVT) in patients with acute ischaemic stroke (AIS) and large vessel occlusion (LVO) significantly improves patient outcomes. Bridging therapy is the current standard of care in these patients. However, an incompletely answered question is whether one thrombolytic agent is better than another during bridging therapy. Aim: The current study aims to understand if one thrombolytic agent is superior to the other during bridging therapy in the treatment of AIS and LVO. Sample size estimates: Using 80% power and an alpha error of 5 %, presuming a 10% drop out rate, a total of 372 patients will be recruited for the study. Methods and design: This study is a prospective, randomised, multicentre, open-label trial with blinded outcome analysis design. Study outcomes: The primary outcomes include proportion of patients who will be independent at 3 months (modified Rankin score (mRS) ≤2 as good outcome) and proportion of patients who achieve recanalisation modified thrombolysis in cerebral infarction grade 2b/3 at first angiography run at the end of EVT. Secondary outcomes include proportion of patients with early neurological improvement, rate of symptomatic intracerebral haemorrhage (ICH), rate of any ICH, rate of any systemic major or minor bleeding and duration of hospital stay. Safety outcomes include any intracranial bleeding or symptomatic ICH. Discussion: This trial is envisioned to confirm the theoretical advantages and increase the strength and quality of evidence for use of tenecteplase (TNK) in practice. Also, it will help to generate data on the efficacy and safety of biosimilar TNK. Trial registration number: CTRI/2022/01/039473.

Association Between CYP2C19 Genotypes With Clinical Phenotypes and Adipokine Levels Among Ischemic Stroke Patients: A Prospective Observational Study.

Background Cytochrome P450 system is implicated in vascular pathologies, including stroke. Besides its role as a drug metabolizer, it also plays an important role in the metabolism of several endogenous substances like fatty acids, arachidonic acid, etc., which have pro-inflammatory effects. On the other hand, leptin and adiponectin are two of the most common adipose tissue-derived cytokines (adipokines), which are pro-inflammatory and anti-inflammatory in nature, respectively. Both of them are implicated in the pathogenesis of stroke. Methods We prospectively recruited ischemic stroke patients (within three months of occurrence of an attack of stroke). The occurrence of composite outcome (recurrence of transient ischemic attack/ischemic stroke or death) was evaluated for association with genetic variants of CYP2C19 (allele *2, *17, *3, and *4, i.e., single nucleotide polymorphism (SNP) 1/2/3/4, identified using TaqMan assays and DNA sequencing). Adiponectin and leptin levels were determined using an enzyme-linked immunosorbent assay. Comparisons were made between stroke vs. control patients and between CYP2C19 intermediate metabolizer (IM)/poor metabolizer (PM) vs. extensive metabolizer (EM)/ultra metabolizer (UM) (PM: *2/*2; IM: *1/*2 vs. EM: *1/*1; UM: *1/*17). P < 0.05 was taken as the threshold for statistical significance. Results A total of 204 patients and 101 controls were recruited. With regard to the occurrence of stroke, SNP2 showed a significant positive association. Haplotypes (SNP1/SNP2) AC (OR = 1.75 (1.08-2.83), p = 0.024) and GT (OR = 3.33 (1.53-7.22), p = 0.0026) were strongly associated with the occurrence of ischemic stroke even after adjustment for age and sex (global haplotype association p-value: 0.0062). Haplotype phenotype gender interaction was evident. Among stroke patients, with regard to composite outcome, only SNP1 showed a positive association. The AC haplotype was significantly associated with the occurrence of composite outcome (OR = 2.27 (1.17-4.41), p = 0.016). Among stroke patients, a significant positive association was seen between death and SNP1 (OR = 2.35 (1.13-4.90), p = 0.021) and AC haplotype (OR = 2.73 (1.20-6.22), p = 0.018). However, none of the SNPs or haplotypes showed any association with recurrence. Significant higher leptin and lower adiponectin levels were observed among stroke patients compared to controls. Leptin levels were higher in IM/PM group. IM/PM phenotypes showed a higher incidence of occurrence of composite outcome (hazard ratio = 2.07 (0.96-4.47), p = 0.056). Conclusion CYP2C19 polymorphisms may play a significant role in the pathogenesis of stroke. Leptin could serve as a prominent biomarker of atherosclerosis and inflammation in the early post-stroke period; however, further study is warranted with a larger sample size.

Reperfusion by endovascular thrombectomy and early cerebral edema in anterior circulation stroke: Results from the SITS-International Stroke Thrombectomy Registry.

BACKGROUND: A large infarct and expanding cerebral edema (CED) due to a middle cerebral artery occlusion confers a 70% mortality unless treated surgically. There is still conflicting evidence whether reperfusion is associated with a lower risk for CED in acute ischemic stroke. AIM: To investigate the association of reperfusion with development of early CED after stroke thrombectomy. METHODS: From the SITS-International Stroke Thrombectomy Registry, we selected patients with occlusion of the intracranial internal carotid or middle cerebral artery (M1 or M2). Successful reperfusion was defined as mTICI ⩾ 2b. Primary outcome was moderate or severe CED, defined as focal brain swelling ⩾1/3 of the hemisphere on imaging scans at 24 h. We used regression methods while adjusting for baseline variables. Effect modification by severe early neurological deficits, as indicators of large infarct at baseline and at 24 h, were explored. RESULTS: In total, 4640 patients, median age 70 years and median National Institutes of Health Stroke Score (NIHSS) 16, were included. Of these, 86% had successful reperfusion. Moderate or severe CED was less frequent among patients who had reperfusion compared to patients without reperfusion: 12.5% versus 29.6%, p < 0.05, crude risk ratio (RR) 0.42 (95% confidence interval (CI): 0.37-0.49), and adjusted RR 0.50 (95% CI: 0.44-0.57). Analysis of effect modification indicated that severe neurological deficits weakened the association between reperfusion and lower risk of CED. The RR reduction was less favorable in patients with severe neurological deficits, defined as NIHSS score 15 or more at baseline and at 24 h, used as an indicator for larger infarction. CONCLUSION: In patients with large artery anterior circulation occlusion stroke who underwent thrombectomy, successful reperfusion was associated with approximately 50% lower risk for early CED. Severe neurological deficit at baseline seems to be a predictor for moderate or severe CED also in patients with successful reperfusion by thrombectomy.

Characteristics, clinical practice patterns, and outcomes of strokes in India: INSPIRE-A multicentre prospective study.

BACKGROUND: India has a high burden of stroke, but there are limited data available on the characteristics of patients presenting with stroke in India. AIMS: We aimed to document the clinical characteristics, practice patterns, and outcomes of patients presenting with acute stroke to Indian hospitals. METHODS: A prospective registry study of patients admitted with acute clinical stroke was conducted in 62 centers across different regions in India between 2009 and 2013. RESULTS: Of the 10,329 patients included in the prescribed registry, 71.4% had ischemic stroke, 25.2% had intracerebral hemorrhage (ICH), and 3.4% had an undetermined stroke subtype. Mean age was 60 years (SD = 14) with 19.9% younger than 50 years; 65% were male. A severe stroke at admission (modified-Rankin score 4-5) was seen in 62%, with 38.4% of patients having severe disability at discharge or dying during hospitalization. Cumulative mortality was 25% at 6 months. Neuroimaging was completed in 98%, 76% received physiotherapy, 17% speech and language therapy (SLT), 7.6% occupational therapy (OT), with variability among sites; 3.7% of ischemic stroke patients received thrombolysis. Receipt of physiotherapy (odds ratio (OR) = 0.41, 95% confidence interval (CI): 0.33-0.52) and SLT (OR = 0.45, 95% CI: 0.32-0.65) was associated with lower mortality, while a history of atrial fibrillation (OR = 2.22, 95% CI: 1.37-3.58) and ICH (OR = 2.00, 95% CI: 1.66-2.40) were associated with higher mortality. CONCLUSION: In the INSPIRE (In Hospital Prospective Stroke Registry) study, one-in-five patients with acute stroke was under 50 years of age, and one-quarter of stroke was ICH. There was a low provision of thrombolysis and poor access to multidisciplinary rehabilitation highlighting how improvements are needed to reduce morbidity and mortality from stroke in India.

Simple CaroTID-VasC score to predict one-year risk of stroke in symptomatic carotid stenosis patients.

BACKGROUND: A subset of extracranial symptomatic carotid stenosis (ESCS) patients may fare well on current optimal medical therapy (OMT), and surgery may be avoided in these patients. Therefore, we aimed to develop and validate a stroke risk prediction model to stratify the risk among ESCS patients. METHODS: Adult ESCS patients who denied revascularization procedures were enrolled prospectively and prescribed OMT. Patients were followed-up for twelve months after assessing the clinical, imaging, and hemodynamics-based risk predictors at baseline. Cox regression analysis was performed on predictors which were significant in univariate analysis. Beta coefficients of significant predictors in Cox regression were used to generate a numeric score. The model was internally validated using bootstrapping. RESULTS: A total of 20 (20.2%) out of 99 patients had event recurrence during the follow-up. Transient ischemic attack index event (P = 0.014), diabetes mellitus (P = 0.018), contralateral significant stenosis (P = 0.007), echolucent plaque (P = 0.011), and impaired vasomotor reactivity (P = 0.006) were significant predictors in Cox regression analysis. A points score (0-6) was derived from regression coefficients of the significant predictors. The area under ROC was 0.884 for the developed model and 0.832 for the bootstrapped model. Youden's index divided the score into low-risk (2.2%) and high-risk (35.8%) groups, and the difference in risk was significant (P < 0.001). CONCLUSIONS: Most ESCS patients benefited from OMT, and the CaroTID-VasC score was effective in stratifying patients for risk of endpoint occurrence. The developed model may help identify high-risk subgroups of ESCS patients and assist the decision-making of carotid interventions.

Non-association of stroke risk with intracranial hemodynamic steal in patients with symptomatic internal carotid artery occlusions.

OBJECTIVES: Paradoxical intracranial hemodynamic steal (IHS) is known in patients having persistent proximal arterial occlusions and is linked with early neurological worsening. However, stroke risk specific to symptomatic internal carotid artery occlusions (SICAO) having paradoxical IHS is unknown. Therefore, we aimed to investigate the association of paradoxical IHS in SICAO patients with stroke recurrence during a one-year follow-up. MATERIALS AND METHODS: We prospectively enrolled adult patients having SICAO with a recent history of ischemic events. Steal magnitude (SM) to classify patients in IHS and non-IHS categories was evaluated by a breath-holding test using bilateral transcranial doppler (TCD). Patients were prescribed optimal medical therapy and followed up for one year for any ischemic stroke/TIA/cardiovascular death. RESULTS: 36 SICAO patients, mean age of 56 years, were assessed using TCD at median 22.5 days (Interquartile range, IQR= 9-42), and 11 (30.6%) had paradoxical IHS with median SM 12% (IQR= 6%-18%). On follow-up, 7 (19.4%) patients had event recurrence and its association with IHS was non-significant (IHS vs non-IHS, 18.2% vs 20%; Log-rank statistics=0.006; P=0.940). On Cox regression analysis, event recurrence was independently associated with the presence of significant contralateral stenosis only (regression coefficient= 2.237; P= 0.012; 95% CI= 1.63-53.89). CONCLUSIONS: IHS prevalence among SICAO is high. However, paradoxical IHS was not associated with an increased risk of stroke in SICAO. Therefore, the presence of paradoxical IHS in SICAO may be considered a transit state and does not necessarily imply an increased risk of stroke.

Modeling, Simulation and Validation of Alteration in Blood Flow and Regional Oxygenation Under Arterial Occlusion.

The paper presents the mathematical modeling along with an experimental approach for the identification of arterial occlusion condition. Arterial occlusion occurs due to development of constriction and/or thrombus in the lumen of the artery. A geometry of the thrombus has been modeled for the analysis of the arterial occlusion condition in modeling part. The proposed model of the thrombus has been simulated using Comsol® multiphysics considering different hemodynamic parameters. Variation in regional oxygen saturation (rSO2) of the arterial occlusion condition has been validated with experimental process, where occlusion of the artery has been done by applying external pressure. The experimental study has been conducted to monitor alteration in rSO2 level profile for occlusion using near infrared spectroscopy (NIRS) methodology. NIRS signal data has been collected from twenty-three subjects with no reported musculoskeletal, psychiatric, or any other neurological deficits using Mespere NeurOs® oxymeter. Experimental data reveal that the oxygenation level decreases considerably due to arterial occlusion as compared to the healthy condition at 95% of confidence interval (p < .05). Dynamic time warping algorithm reveals that variation in rSO2 due to proposed thrombus geometry has more similarity with experimental study.

Comparative effectiveness of two behavioral change intervention packages for tobacco cessation initiated in the tertiary care setting of North India-protocol for a two-arm randomized controlled trial.

BACKGROUND: To reduce the global burden of tobacco use, clinical guidelines support behavioral therapy and pharmacotherapy as preferred interventions for tobacco cessation. The evidence-based behavioral interventions has consistently shown to be impactful in community settings; however, its efficacy has not been established in hospital settings. The current study aims to investigate impact of trans-theoretical-based behavioral intervention package on tobacco users suffering from non-communicable diseases attending tertiary care settings of North India. METHODS/DESIGN: A two-arm randomized controlled trial (RCT) in a tertiary healthcare hospital will be performed. A total of 360 tobacco users attending NCD clinics in four departments, cardiology, neurology, pulmonary medicine, and ENT (otolaryngology), will be recruited over a period of 3 months. After ascertaining the eligibility criteria, they will be followed up to 6 months (1, 3, 6) for their tobacco use status, readiness to quit, nicotine dependence, stage of behavior change, and self-reported and biochemical validation (urine cotinine) for tobacco abstinence. Assignment of intervention including allocation concealment, sequence generation, and blinding will be done as per SPIRIT guidelines for RCT protocols. DISCUSSION: As no strong evidence exists about the effectiveness of tobacco cessation intervention in tertiary settings, the current study will build evidence about the similar interventions in such settings. TRIAL REGISTRATION: CTRI/2019/09/021406.

Measurement of Near infrared Spectroscopy based Biomarkers under in-vitro Ischemic stroke condition.

Near infrared spectroscopy (NIRS) is an optical method which has been used widely to measure the change in the blood chromophores. Abrupt change in blood chromophore viz, oxyhemoglobin [hbo2] and deoxyhemoglobin [hb] happens in ischemia stroke condition, which occurs due to impairment of the oxygenated compounds viz, oxygen and glucose. The current study presents measurement and analysis of near infrared spectroscopy (NIRS) based regional oxygenation level biomarkers Viz., change in regional blood volume index [Formula: see text] and change in regional oxygen saturation [Formula: see text]. To measure these NIRS biomarkers dynamic phantom has been designed in such a way that, it mimics the ischemic stroke condition in-vitro by continuously changing (decrease, increase) the oxygenation level of human blood sample in the closed loop arterial system of dynamic phantom. Continuous decline of the [Formula: see text] % and [Formula: see text] 5% has been observed of the average reading of the samples in an ischemic stroke condition, while 15% and 2% increment has been recorded in reversal of ischemic stroke condition, by increasing the oxygenation level of the arterial system. Correlation between biomarkers in ischemic stroke condition has been found strongly positive (r=56%) and regular residual percentage error in measurement has been measured which has found under 10%. Clinical Relevance- This help in understanding and characterizing the ischemic stroke. Biomarker's trend can be use for classification of stroke types.

Smartphone-Based Telestroke Vs"Stroke Physician" led Acute Stroke Management (SMART INDIA): A Protocol for a Cluster-Randomized Trial.

Background: One of the major challenges is to deliver adequate health care in rural India, where more than two-thirds of India's population lives. There is a severe shortage of specialists in rural areas with one of the world's lowest physician/population ratios. There is only one neurologist per 1.25 million population. Stroke rehabilitation is virtually nonexistent in most district hospitals. Two innovative solutions include training physicians in district hospitals to diagnose and manage acute stroke ('Stroke physician model') and using a low-cost Telestroke model. We will be assessing the efficacy of these models through a cluster-randomized trial with a standard of care database maintained simultaneously in tertiary nodal centers with neurologists. Methods: SMART INDIA is a multicenter, open-label cluster-randomized trial with the hospital as a unit of randomization. The study will include district hospitals from the different states of India. We plan to enroll 22 district hospitals where a general physician manages the emergency without the services of a neurologist. These units (hospitals) will be randomized into either of two interventions using computer-generated random sequences with allocation concealment. Blinding of patients and clinicians will not be possible. The outcome assessment will be conducted by the blinded central adjudication team. The study includes 12 expert centers involved in the Telestroke arm by providing neurologists and telerehabilitation round the clock for attending calls. These centers will also be the training hub for "stroke physicians" where they will be given intensive short-term training for the management of acute stroke. There will be a preintervention data collection (1 month), followed by the intervention model implementation (3 months). Outcomes: The primary outcome will be the composite score (percentage) of performance of acute stroke care bundle assessed at 1 and 3 months after the intervention. The highest score (100%) will be achieved if all the eligible patients receive the standard stroke care bundle. The study will have an open-label extension for 3 more months. Conclusion: SMART INDIA assesses whether the low-cost Telestroke model is superior to the stroke physician model in achieving acute stroke care delivery. The results of this study can be utilized in national programs for stroke and can be a role model for stroke care delivery in low- and middle-Income countries. (CTRI/2021/11/038196).

Prevalence of Patent Foramen Ovale in North Indian Cryptogenic Young Strokes.

Background: : Strokes of the undetermined cause or cryptogenic strokes (CS) account for 30-40% of ischemic strokes. Paradoxical embolism secondary to patent foramen ovale (PFO) may be associated with CS. Transcranial Doppler (TCD) with bubble contrast is a noninvasive bedside tool for diagnosis of right-to-left shunt (RLS) with high sensitivity and specificity. Data on the prevalence of PFO in CS in India are lacking. We determined the prevalence of RLS likely secondary to PFO in cryptogenic young strokes of the north Indian population using TCD with bubble contrast. Patients and Methods: : In this hospital-based prospective cross-sectional study, TCD with bubble contrast was performed in 57 young (age 15 > 45 years) CS and 50 healthy controls for the detection of RLS. The risk of paradoxical embolism (RoPE) score was calculated from various variables such as age, presence of cortical stroke on neuroimaging, and absence of vascular risk factors. Results: : 57 young CS and 50 healthy controls were recruited. TCD with bubble contrast was positive in 31% cases vs 6% in controls (P = 0.001). All patients with TCD positive for RLS had superficial cortical infarcts (P = 0.03). The median RoPE score of our patients was 9 (range: 7-10). Conclusions: : There is a high prevalence of RLS likely secondary to PFO in cryptogenic young strokes in north India. TCD with bubble contrast is an excellent bedside tool for the detection of RLS.

Intravenous Thrombolysis with Tenecteplase for the Treatment of Acute Ischemic Stroke.

OBJECTIVE: Intravenous thrombolysis (IVT) with tenecteplase has been associated with better clinical outcomes in acute ischemic stroke (AIS) patients with confirmed large vessel occlusions compared to IVT with alteplase. However, the utility of tenecteplase for the treatment of all AIS patients eligible for IVT has not been established. METHODS: We compared the safety and efficacy of tenecteplase versus alteplase in AIS patients by analyzing propensity score matched data from 20 centers participating in the Safe Implementation of Treatments in Stroke-International Stroke Thrombolysis Register. Patients receiving IVT with tenecteplase were matched with up to 3 patients receiving alteplase from the same center. The primary outcome of interest was the distribution of 3-month functional outcomes. Secondary outcomes included the rates of patients with symptomatic intracranial hemorrhage (SICH) in the first 24 hours, excellent (modified Rankin Scale [mRS] score = 0-1) or good (mRS score = 0-2) functional outcome, and all-cause mortality at 3 months. RESULTS: A total of 331 tenecteplase-treated AIS patients were matched to 797 patients treated with alteplase (median age = 70 years, 43.9% women, median National Institutes of Health Stroke Scale score = 11, interquartile range = 6-17). Patients treated with tenecteplase had better 3-month functional outcomes (common odds ratio [OR] = 1.54, 95% confidence interval [CI] = 1.18-2.00) with higher odds of good functional outcome (OR = 2.00, 95% CI = 1.45-2.77) and a lower likelihood of all-cause mortality (OR = 0.43, 95% CI = 0.27-0.67) at 3 months, compared to alteplase-treated patients. No difference was found in the likelihood of the 3-month excellent functional outcomes (OR = 1.31, 95% CI = 0.96-1.78) and 24-hour SICH (1.0% vs 1.3%, OR = 0.72, 95% CI = 0.20-2.64). INTERPRETATION: IVT with tenecteplase was associated with better 3-month clinical outcomes compared to IVT with alteplase in AIS patients, with no increased risk of symptomatic intracranial bleeding. ANN NEUROL 2022;92:349-357.

Clinical profile and outcome of non-COVID strokes during pandemic and the pre pandemic period: COVID-Stroke Study Group (CSSG) India.

BACKGROUND: As the health systems around the world struggled to meet the challenges of COVID-19 pandemic, care of many non-COVID emergencies was affected. AIMS: The present study examined differences in the diagnosis, evaluation and management of stroke patients during a defined period in the ongoing pandemic in 2020 when compared to a similar epoch in year 2019. METHODS: The COVID stroke study group (CSSG) India, included 18 stroke centres spread across the country. Data was collected prospectively between February and July 2020 and retrospectively for the same period in 2019. Details of demographics, stroke evaluation, treatment, in-hospital and three months outcomes were collected and compared between these two time points. RESULTS: A total of 2549 patients were seen in both study periods; 1237 patients (48.53%) in 2019 and 1312 (51.47%) in 2020. Although the overall number of stroke patients and rates of thrombolysis were comparable, a significant decline was observed in the month of April 2020, during the initial period of the pandemic and lockdown. Endovascular treatment reduced significantly and longer door to needle and CT to needle times were observed in 2020. Although mortality was higher in 2020, proportion of patients with good outcome were similar in both the study periods. CONCLUSIONS: Although stroke admissions and rates of thrombolysis were comparable, some work flow metrics were delayed, endovascular stroke treatment rates declined and mortality was higher during the pandemic study period. Reorganization of stroke treatment pathways during the pandemic has likely improved the stroke care delivery across the globe.

INSTRuCT: Protocol, Infrastructure, and Governance.

Background and Purpose: Very few large scale multicentric stroke clinical trials have been done in India. The Indian Council of Medical Research funded INSTRuCT (Indian Stroke Clinical Trial Network) as a task force project with the objectives to establish a state-of-the-art stroke clinical trial network and to conduct pharmacological and nonpharmacological stroke clinical trials relevant to the nation and globally. The purpose of the article is to enumerate the structure of multicentric stroke network, with emphasis on its scope, challenges and expectations in India. Methods: Multiple expert group meetings were conducted by Indian Council of Medical Research to understand the scope of network to perform stroke clinical trials in the country. Established stroke centers with annual volume of 200 patients with stroke with prior experience of conducting clinical trials were included. Central coordinating center, standard operating procedures, data and safety monitoring board were formed. Discussion: In first phase, 2 trials were initiated namely, SPRINT (Secondary Prevention by Structured Semi-Interactive Stroke Prevention Package in India) and Ayurveda treatment in the rehabilitation of patients with ischemic stroke in India (RESTORE [Rehabilitation of Ischemic stroke Patients in India: A Randomized controlled trial]). In second phase, 4 trials have been approved. SPRINT trial was the first to be initiated. SPRINT trial randomized first patient on April 28, 2018; recruited 3048 patients with an average of 128.5 per month so far. The first follow-up was completed on May 27, 2019. RESTORE trial randomized first patient on May 22, 2019; recruited 49 patients with an average of 3.7 per month so far. The first follow-up was completed on August 30, 2019. Conclusions: In next 5 years, INSTRuCT will be able to complete high-quality large scale stroke trials which are relevant globally. REGISTRATION: URL: http://www.ctri.nic.in/; Unique Identifier: CTRI/2017/05/008507.

Impact of revascularization therapies on outcome of posterior circulation ischemic stroke: The Indo-US stroke project.

INTRODUCTION: Posterior circulation strokes (PCS) have been less extensively studied than anterior circulation strokes (ACS), especially regarding revascularization therapies. We analyzed the differences in baseline stroke characteristics, revascularization therapy and 3-month outcomes between PCS and ACS in a large prospective multicentre Indian stroke registry. METHODS: Patients with acute ischemic stroke recruited in the Indo-US collaborative stroke project from January 2012 to August 2014 were classified into PCS and ACS based on imaging-confirmed infarct location. Demographics, stroke severity, risk factors, and mechanisms were compared. We further compared these parameters in the subgroups who received revascularization therapies (RT) and no revascularization therapies (NRT). The primary outcome was 3-month modified Rankin scale (mRS). RESULTS: Of 1889 patients (1270 males), 1478 (78.2%) had ACS and 411 (21.8%) PCS. The median NIHSS was lower in PCS (7 vs 11, p < 0.001). Diabetes mellitus and hypertension were more common in PCS and rheumatic heart disease in ACS. Small artery occlusion was higher in PCS (23.8% vs 12.9%, p < 0.001). Only 28 (6.8%) PCS received RT compared to 213 (14.4%) ACS. At 90 days, a good functional outcome (mRS 0-2) was more common in PCS (56.4% vs 45.9%, p < 0.001) in NRT group, while no significant difference was noted in RT group. Stroke territory was not an independent predictor of 3-month outcome in regression analysis. In-hospital mortality was not different between the groups. CONCLUSIONS: The 3-month functional outcome and in-hospital mortality were not different between ACS and PCS. Compared to ACS, PCS received revascularization therapies less often.

Clinical Features and Outcome of Stroke with COVID-19. COVID-19 Stroke Study Group (CSSG), India.

BACKGROUND AND PURPOSE: Occurrence of stroke has been reported among patients with COVID-19. The present study compares clinical features and outcomes of stroke patients with and without COVID-19. METHODS: The COVID-19 Stroke Study Group (CSSG) is a multicentric study in 18 sites across India to observe and compare the clinical characteristics of patients with stroke admitted during the current pandemic period and a similar epoch in 2019. The present study reports patients of stroke with and without COVID-19 (CoVS and non-CoVS, respectively) seen between February 2020 and July 2020. Demographic, clinical, treatment, and outcome details of patients were collected. RESULTS: The mean age and gender were comparable between the two groups. CoVS patients had higher stroke severity and extent of cerebral involvement on imaging. In-hospital complications and death were higher among CoVS patients (53.06% vs. 17.51%; P < 0.001) and (42.31% vs. 7.6%; P < 0.001), respectively. At 3 months, higher mortality was observed among CoVS patients (67.65% vs. 13.43%; P < 0.001) and good outcome (modified Rankin score [mRS]: 0-2) was seen more often in non-CoVS patients (68.86% vs. 33.33%; P < 0.001). The presence of COVID-19 and baseline stroke severity were independent predictors of mortality. CONCLUSIONS: CoVS is associated with higher severity, poor outcome, and increased mortality. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and baseline stroke severity are independent predictors of mortality.

Impact of Pre-Stroke Antiplatelet Use on 3-Month Outcome After Ischemic Stroke.

BACKGROUND: Pre-stroke anti-platelet (PAP) therapy can potentially influence the severity and outcome after ischemic stroke. METHODS: We analyzed data from the prospective multicenter Indo-US collaborative stroke project for the impact of PAP therapy. Outcome measures included the admission National Institute of Health Stroke Scale (NIHSS) score, 3-month modified Rankin scale (mRS) score, and rates of in-hospital mortality and post-ischemic intracerebral hemorrhage. RESULTS: Among 2048 of 2066 patients (M:F = 2:1) with known pre-stroke medication status, 336 (16.3%) were on PAP therapy. As compared to the non-PAP group, the PAP group had significantly higher mean age (62.2 vs 57.4 years, P < 0.001) and significantly more men, vascular risk factors, cerebral microbleeds (12.8% vs 6.2%, P = 0.001) and intravenous thrombolysis treatment (17% vs. 10.6%, P = 0.001). Cardioembolic strokes were significantly more in the PAP group (P < 0.001), but not large artery atherosclerosis. No significant differences were observed in the median NIHSS score (9 vs. 10, P = 0.274), 3-month mRS (score 0-2,51.4% vs. 49.0%, P = 0.428), in-hospital mortality (8.6% vs. 7.8%, P = 0.592), or symptomatic post ischemic intracerebral haemorrhage (12.2% vs. 10.6%, P = 0.382). The PAP group had more stroke recurrence (6.6% vs. 2.9%, P = 0.002) which was not significant (P = 0.065) after multivariate regression analysis adjusting for age, sex and vascular risk factors. PAP therapy was not an independent predictor of initial stroke severity or stroke outcome. CONCLUSION: PAP therapy has no significant effect on initial stroke severity, rates of post-ischemic hemorrhage with or without thrombolysis, in-hospital mortality, stroke recurrence, and 3-month outcome after ischemic stroke.