Acute coronary syndrome quality improvement in Kerala (ACS QUIK): Rationale and design for a cluster-randomized stepped-wedge trial.

Ischemic heart disease is the leading cause of death in India, and there are likely more myocardial infarctions in India than in any other country in the world. We have previously reported heterogeneous care for patients with myocardial infarction in Kerala, a state in southern India, including both gaps in optimal care and inappropriate care. Based on that prior work, limitations from previous nonrandomized quality improvement studies and promising gains in process of care measures demonstrated from previous randomized trials, we and the Cardiological Society of India-Kerala chapter sought to develop, implement, and evaluate a quality improvement intervention to improve process of care measures and clinical outcomes for these patients. In this article, we report the rationale and study design for the ACS QUIK cluster-randomized stepped-wedge clinical trial (NCT02256657) in which we aim to enroll 15,750 participants with acute coronary syndromes across 63 hospitals. To date, most participants are men (76%) and have ST-segment elevation myocardial infarction (63%). The primary outcome is 30-day major adverse cardiovascular events defined as death, recurrent infarction, stroke, or major bleeding. Our secondary outcomes include health-related quality of life and individual- and household-level costs. We also describe the principal features and limitations of the stepped-wedge study design, which may be important for other investigators or sponsors considering cluster-randomized stepped-wedge trials.

Presentation, management, and outcomes of 25 748 acute coronary syndrome admissions in Kerala, India: results from the Kerala ACS Registry.

AIMS: There are limited contemporary data on the presentation, management, and outcomes of acute coronary syndrome (ACS) admissions in India. We aimed to develop a prospective registry to address treatment and health systems gaps in the management of ACSs in Kerala, India. METHODS AND RESULTS: We prospectively collected data on 25 748 consecutive ACS admissions from 2007 to 2009 in 125 hospitals in Kerala. We evaluated data on presentation, management, and in-hospital mortality and major adverse cardiovascular events (MACE). We created random-effects multivariate regression models to evaluate predictors of outcomes while accounting for confounders. Mean (SD) age at presentation was 60 (12) years and did not differ among ACS types [ST-segment myocardial infarction (STEMI) = 37%; non-STEMI = 31%; unstable angina = 32%]. In-hospital anti-platelet use was high (>90%). Thrombolytics were used in 41% of STEMI, 19% of non-STEMI, and 11% of unstable angina admissions. Percutaneous coronary intervention rates were marginally higher in STEMI admissions. Discharge medication rates were variable and generally suboptimal (<80%). In-hospital mortality and MACE rates were highest for STEMI (8.2 and 10.3%, respectively). After adjustment, STEMI diagnosis (vs. unstable angina) [odds ratio (OR) (95% confidence interval = 4.06 (2.36, 7.00)], symptom-to-door time >6 h [OR = 2.29 (1.73, 3.02)], and inappropriate use of thrombolysis [OR = 1.33 (0.92, 1.91)] were associated with higher risk of in-hospital mortality and door-to-needle time <30 min [OR = 0.44 (0.27, 0.72)] was associated with lower mortality. Similar trends were seen for risk of MACE. CONCLUSION: These data represent the largest ACS registry in India and demonstrate opportunities for improving ACS care.

Prevalence of Brugada electrocardiographic pattern in adult population - A community-based study from Kerala, South India.

There is no data for Brugada electrocardiographic pattern (BrEP) from India. In a cross-sectional study of men and women between the ages 20-79 years, electrocardiograms were analyzed following the 2002 consensus. The overall prevalence of BrEP was 1.06 % (95 % CI 0.76, 1.35). There were two cases type I (0.04 %; 95 % CI 0.01, 0.06) and forty-seven type II/III (1.01 %; 95 % CI 1.02, 1.35); the pattern was markedly higher in men. In this study, BrEP was slightly less prevalent compared to South Asia but more than in the west.

COVID-19 infected ST-Elevation myocardial infarction in India (COSTA INDIA).

OBJECTIVE: To find out differences in the presentation, management and outcomes of COVID-19 infected STEMI patients compared to age and sex-matched non-infected STEMI patients treated during the same period. METHODS: This was a retrospective multicentre observational registry in which we collected data of COVID-19 positive STEMI patients from selected tertiary care hospitals across India. For every COVID-19 positive STEMI patient, two age and sex-matched COVID-19 negative STEMI patients were enrolled as control. The primary endpoint was a composite of in-hospital mortality, re-infarction, heart failure, and stroke. RESULTS: 410 COVID-19 positive STEMI cases were compared with 799 COVID-19 negative STEMI cases. The composite of death/reinfarction/stroke/heart failure was significantly higher among the COVID-19 positive STEMI patients compared with COVID-19 negative STEMI cases (27.1% vs 20.7% p value = 0.01); though mortality rate did not differ significantly (8.0% vs 5.8% p value = 0.13). Significantly lower proportion of COVID-19 positive STEMI patients received reperfusion treatment and primary PCI (60.7% vs 71.1% p value=< 0.001 and 15.4% vs 23.4% p value = 0.001 respectively). Rate of systematic early PCI (pharmaco-invasive treatment) was significantly lower in the COVID-19 positive group compared with COVID-19 negative group. There was no difference in the prevalence of high thrombus burden (14.5% and 12.0% p value = 0.55 among COVID-19 positive and negative patients respectively) CONCLUSIONS: In this large registry of STEMI patients, we did not find significant excess in in-hospital mortality among COVID-19 co-infected patients compared with non-infected patients despite lower rate of primary PCI and reperfusion treatment, though composite of in-hospital mortality, re-infarction, stroke and heart failure was higher.

Prevalence, Awareness, Treatment, and Control of Hypertension in Young Adults (20-39 Years) in Kerala, South India.

Objective: We sought to study the prevalence of hypertension and the levels of awareness, treatment and control of hypertension in the young adults in Kerala, India compared to older adults. Methods: We identified 1,221 young adults (men 36.7%) in the age group 20-39 years from the 5,150 participants of the Cardiological Society of India Kerala Coronary artery disease (CAD) and its Risk factors Prevalence (CSI Kerala CRP) Study. We determined prevalence and levels of awareness, treatment and control of hypertension among them compared to older adults. Results: We found that among the young adults, 11.2% had hypertension and 33.3% had prehypertension. Hypertension was nearly three times more prevalent among men than women (20.5 vs. 7.5% p < 0.001) while in older adults there was no difference between men and women in its prevalence. Male sex (OR 3.36, 95% CI 2.15-5.25 p-value <0.001), urban residence (OR 2.21, 95% CI 1.52-3.22 p-value <0.001), abdominal obesity (OR 1.74, 95% CI 1.06-2.87 p-value 0.028) and hypercholesterolemia (OR 1.64 95% CI 1.12-2.40 p-value 0.011) were significant factors favoring hypertension in the young adults. Awareness and treatment of hypertension were significantly poor among younger adults compared to older adults. In young adults, awareness, treatment and control of hypertension were significantly lower among men compared to women (23.9 vs. 51.7% p-value 0.001, 12.0 vs. 25.9% p-value 0.045, and 18.5 vs. 37.9% p-value 0.012, respectively). Participants who had checked blood pressure at least once during the previous year had significantly better awareness and treatment (58.7 vs. 24.0% and 41.3 vs. 19.2%, respectively). Conclusions: We found that one eighth of young subjects had hypertension with three times higher prevalence of hypertension among men compared to women. Awareness, treatment and control of hypertension were less among young adults and worse in young men compared to young women. Identifying hypertension and measures to control it are important and should be specifically targeted to young men.

A community-based study on electrocardiographic abnormalities of adult population from South India - Findings from a cross sectional survey.

BACKGROUND: There are no data on electrocardiographic (ECG) findings from general population of Indian subcontinent. We analyzed ECG abnormalities of in adults as part of a community survey of prevalence of coronary artery disease and risk factors from South India. METHODS AND RESULTS: In this cross-sectional study of men and women between the ages 20 to 79 years, ECGs recorded digitally were analyzed using the Minnesota code. Electrocardiograms were analyzed for abnormalities in 4630 participants (women 59.6%). The overall prevalence of ECG abnormalities (39.9%) was higher in men (47.24% vs. 34.9% p <0.0001). QRS axis deviation, first degree AV block, fascicular blocks, incomplete right bundle branch block, sinus bradycardia and ST elevation in the anterior chest leads were markedly higher in men. Sinus tachycardia and low voltage QRS occurred more often in women. The overall prevalence of atrial fibrillation was 0.32% which was markedly lower than the western data. Brugada and early repolarisation patterns occurred in 1.06% and 1.56% respectively, equal in both age groups, but markedly higher in men. Brugada pattern occurred more often than in the west, but much less than the Far East population. Early repolarisation pattern was similar to rest of Asian population, but significantly less than the Caucasian population CONCLUSION: In this community-based study, prevalence of major electrocardiographic abnormalities was high. Overall, men had significantly higher ECG abnormalities.

Pattern of acute MI admissions in India during COVID-19 era: A Cardiological Society of India study - Rationale and design.

BACKGROUND: COVID-19 pandemic has affected around 20million patients worldwide and 2.0 million cases from India. The lockdown was employed to delay the pandemic. However, it had an unintentional impact on acute cardiovascular care, especially acute myocardial infarction (AMI). Observational studies have shown a decrease in hospital admissions for AMI in several developed countries during the pandemic period. We aimed to evaluate the impact of COVID-19 on the AMI admissions patterns across India. METHODS: In this multicentric, retrospective, cross-sectional study, we included all AMI cases admitted to participating hospitals during the study period 15th March to 15th June 2020 and compared them using a historical control of all cases of AMI admitted during the corresponding period in the year 2019. Major objective of the study is to analyze the changes inthe number of hospital admissions for AMI in hospitals across India. In addition, we intend to evaluate the impact of COVID-19 on the weekly AMI admission rates, and other performance measures like rates of thrombolysis/primary percutaneous interventions (PCI), window period, door to balloon time, and door to needle time. Other objectives include evaluation of changes in the major complications and mortality rates of AMI and its predictors during COVID-19 pandemic. CONCLUSIONS: This CSI-AMI study will provide scientific evidence about the impact of COVID-19 on AMI care in India. Based on this study, we may be able to suggest appropriate changes to the existing MI guidelines and to educate the public regarding emergency care for AMI during COVID-19 pandemic.

Prevalence of peripheral artery disease and risk factors in the elderly: A community based cross-sectional study from northern Kerala, India.

BACKGROUND AND OBJECTIVE: There are no data on the prevalence of peripheral artery disease (PAD) and risk factors in Indians. This study was aimed at studying the prevalence of PAD and risk factors in elderly population of northern parts of Kerala, South India. METHODS: In a prospective observational survey we evaluated men and women of age between 60 and 79 years from Kerala. Anthropometric measurements, biochemical investigations and electrocardiogram were done. The diagnosis of PAD was made by ABI<0.9. Assessment of coronary artery disease CAD was performed using historical, angina questionnaire and electrocardiographic criteria. RESULTS: Of the total sample of 1330, we could evaluate 1148 respondents (86.3%). Overall mean (SD) ABI was 0.97 (0.19). Age-adjusted prevalence of PAD was 26.7% (95% CI (24.3, 29.4)) with no difference between urban and rural population. Prevalence of symptomatic PAD was low. Diabetes, hypertension, high cholesterol, low high-density lipoprotein cholesterol, sedentary life style and smoking was observed in 25.5%, 62.9%, 61.6%, 35.9% 38.1% and 30.7%, respectively. On multivariate analysis age, smoking and physical inactivity were strong predictors of PAD. There was independent association of PAD with definite CAD. CONCLUSIONS: There was high prevalence of PAD in Kerala, driven by high prevalence of risk factors. The prevalence was equal in rural and urban population. Intermittent claudication was uncommon. Age, female gender, smoking, physical inactivity, diabetes were independent predictors for presence of PAD.

Optimal in-hospital and discharge medical therapy in acute coronary syndromes in Kerala: results from the Kerala acute coronary syndrome registry.

BACKGROUND: In-hospital and postdischarge treatment rates for acute coronary syndrome (ACS) remain low in India. However, little is known about the prevalence and associations of the package of optimal ACS medical care in India. Our objective was to define the prevalence, associations, and impact of optimal in-hospital and discharge medical therapy in the Kerala ACS Registry of 25,718 admissions. METHODS AND RESULTS: We defined optimal in-hospital ACS medical therapy as receiving the following 5 medications: aspirin, clopidogrel, heparin, ß-blocker, and statin. We defined optimal discharge ACS medical therapy as receiving all of the above therapies except heparin. Comparisons by optimal versus nonoptimal ACS care were made via Student t test for continuous variables and χ(2) test for categorical variables. We created random effects logistic regression models to evaluate the association between Global Registry of Acute Coronary Events risk score variables and optimal in-hospital or discharge medical therapy. Optimal in-hospital and discharge medical care were delivered in 40% and 46% of admissions, respectively. Wide variability in both in-hospital and discharge medical care was present, with few hospitals reaching consistently high (>90%) levels. Patients receiving optimal in-hospital medical therapy had an adjusted odds ratio (95% confidence interval)=0.93 (0.71, 1.22) for in-hospital death and an adjusted odds ratio (95% confidence interval)=0.79 (0.63, 0.99) for major adverse cardiovascular event rates. Patients who received optimal in-hospital medical care were far more likely to receive optimal discharge care (adjusted odds ratio [95% confidence interval] = 10.48 [9.37, 11.72]). CONCLUSIONS: Strategies to improve in-hospital and discharge medical therapy are needed to improve local process-of-care measures and ACS outcomes in Kerala.