Randomized Invitation to Systematic NT-proBNP and ECG Screening in 75-Year Olds to Detect Atrial Fibrillation -STROKESTOP II.

Background: Guidelines have suggested screening for atrial fibrillation to enable early treatment and avoid downstream negative clinical events. We aimed to determine if atrial fibrillation screening potentially enhanced by NT-proBNP would reduce stroke or systemic embolism incidence as compared to in a control group and to determine if it was safe for those with low NT-proBNP concentrations to forfeit prolonged screening. Methods: In this randomized controlled trial all 75/76-year-old individuals in Stockholm Region, Sweden were randomized 1:1 to be invited to screening or serve as a control group. NT-proBNP concentration were measured and a single-lead-ECG registered only once if NT-proBNP<125ng/L, whereas if NT-proBNP≥125 ng/L participants underwent prolonged screening, recording single-lead ECGs four times daily for two weeks. If atrial fibrillation was detected, treatment was initiated. Baseline and outcome data were collected from Swedish National Registries. Results: In total 28,712 individuals were randomized, after exclusion of death and emigration 13,905 remained in the intervention group, 13,884 in the control group. Participation rate in the intervention group was 49.2% (6,843/13,905). Participants in the high NT-proBNP group (NT-proBNP≥125 ng/L) without prior atrial fibrillation constituted 60% of the total and underwent prolonged screening. New AF was detected in 2.4% (165/6,843) in the intervention group. There was no difference in AF prevalence or oral anticoagulant treatment between the intervention and the control group after five years follow-up. After a median of 5.1 years (IQR 5.0-5.8) there was no difference in the primary outcome of stroke or systemic embolism between the intervention group and the control group, HR: 0.96 (95% CI 0.86-1.06). The low NT-proBNP-group had significantly fewer strokes or systemic emboli than the control group, HR: 0.59 (95% CI 0.46-0.74), p<0.001. In the high NT-proBNP group the risk of stroke or systemic embolism was higher compared to the low NT-proBNP group, HR: 1.57 (95% CI 1.22-2.02), p=0.001. Conclusions: In this population-based screening trial for atrial fibrillation using NT-proBNP for screening enhancement, there was no difference in risk of stroke or systemic embolism for the intervention group compared to controls. Participation was moderate. The use of NT-proBNP for screening enhancement was safe in identifying low-risk participants. Clinical Trial Registration: www.clinicaltrials.gov; NCT02743416.

Incidence of atrial fibrillation in patients with atrioventricular nodal re-entrant tachycardia and its association with long-term outcome.

Background: Atrioventricular nodal re-entrant tachycardia (AVNRT) is the most common paroxysmal supraventricular tachycardia. We sought to investigate the incidence of atrial fibrillation in patients with electrophysiologically confirmed/ablated AVNRT and its association with transient ischemic attack (TIA)/stroke as well as mortality during long-term follow-up. Methods: From the Karolinska Ablation Registry, 2855 consecutive patients with a first-time ablation for AVNRT between 2005 and 2018 were analyzed. Results: Patients were 52.1 ± 15.9 years old and 59.3% were women. During follow-up of up to 10 years (median 6.0 years; interquartile range 3.3 to 9.2 years), new onset or recurrence of atrial fibrillation occurred in 317 (11.1%) patients (incidence rate 19 cases per 1000 person-years). Excluding those with history of atrial fibrillation, new onset of atrial fibrillation occurred in 153 (6.1%) patients. In multivariable analysis, history of atrial fibrillation, arterial hypertension, history of TIA/stroke, and heart failure remained independently associated with new onset or recurrence of atrial fibrillation during follow-up. Death of any cause and TIA/stroke occurred in 141 (4.9%) patients and 107 (3.7%) patients, respectively. In multivariable analysis, occurrence of atrial fibrillation during follow-up remained independently associated with both outcomes. The prevalence of atrial fibrillation according to age at the end of follow-up was high among young patients (<60 years of age: 12.7%; 60-69 years of age: 10.6%). Conclusion: In this large cohort of patients with diagnosed AVNRT, the incidence of atrial fibrillation was high (11.1%) during long-term follow-up. Occurrence of atrial fibrillation during follow-up remained independently associated with death for any cause as well as with TIA/stroke. Therefore, a closer monitoring for atrial fibrillation in patients with AVNRT including those at young age is advisable.

Expert opinion on design and endpoints for studies on catheter ablation of atrial fibrillation.

INTRODUCTION: Catheter ablation of atrial fibrillation (AF) is frequently studied in randomized trials, observational and registry studies. The aim of this expert opinion is to provide guidance for clinicians and industry regarding the development of future clinical studies on catheter ablation of AF, implement lessons learned from previous studies, and promote a higher degree of consistency across studies. BACKGROUND: Studies on catheter ablation of AF may benefit from well-described definitions of endpoints and consistent methodology and documentation of outcomes related to efficacy, safety and cost-effectiveness. The availably of new, innovative technologies warrants further consideration about their application and impact on study design and the choice of endpoints. Moreover, recent insights gained from AF ablation studies suggest a reconsideration of some methodological aspects. METHODS: A panel of clinical experts on catheter ablation of AF and designing and conducting clinical studies developed an expert opinion on the design and endpoints for studies on catheter ablation of AF. Discussions within the expert panel with the aim to reach consensus on predefined topics were based on outcomes reported in the literature and experiences from recent clinical trials. RESULTS: A comprehensive set of recommendations is presented. Key elements include the documentation of clinical AF, medication during the study, repeated ablations and their effect on endpoint assessments, postablation blanking and the choice of rhythm-related and other endpoints. CONCLUSION: This expert opinion provides guidance and promotes consistency regarding design of AF catheter ablation studies and identified aspects requiring further research to optimize study design and methodology. CONDENSED ABSTRACT: Recent insights from studies on catheter ablation of atrial fibrillation (AF) and the availability of new innovative technologies warrant reconsideration of methodological aspects related to study design and the choice and assessment of endpoints. This expert opinion, developed by clinical experts on catheter ablation of AF provides a comprehensive set of recommendations related to these methodological aspects. The aim of this expert opinion is to provide guidance for clinicians and industry regarding the development of clinical studies, implement lessons learned from previous studies, and promote a higher degree of consistency across studies.

Increasing the reach: optimizing screening for atrial fibrillation-the STROKESTOP III study.

AIMS: Atrial fibrillation (AF) is the most common type of cardiac arrythmia and is an important risk factor for ischaemic stroke. Many cases of AF remain undiagnosed due to its paroxysmal, intermittent, and often asymptomatic nature. Early detection of AF through screening and initiation of treatment with oral anticoagulants can prevent stroke, increase life expectancy, and decrease the cost of healthcare for the society. However, participation has been low in previous AF screening studies employing population screening. The aim of this study is to determine whether opportunistic screening is a superior method to increase participation in comparison to population screening. We hypothesize that opportunistic screening will significantly increase participation. METHODS AND RESULTS: In our study, STROKESTOP III, a randomized prospective cohort study, we compare two different methods of AF screening in high-risk individuals: population screening vs. opportunistic screening. Sixteen different primary clinics in Värmland, Sweden, serving 75-76-year-old individuals (n = 2954), will be randomized to either population screening or opportunistic screening. The individuals will be instructed to record electrocardiogram (ECG) for 30 s, 3 times daily for 2 weeks, using a handheld one-lead ECG device. Patients with detected AF will be referred to their primary healthcare physician and offered treatment. The main objective of the study is to determine the rate of participation in opportunistic screening in comparison to population screening. CONCLUSIONS: The STROKESTOP III study will provide valuable information on which screening method to use for improved participation in atrial fibrillation screening.

Gender and contemporary risk of adverse events in atrial fibrillation.

BACKGROUND AND AIMS: The role of gender in decision-making for oral anticoagulation in patients with atrial fibrillation (AF) remains controversial. METHODS: The population cohort study used electronic healthcare records of 16 587 749 patients from UK primary care (2005-2020). Primary (composite of all-cause mortality, ischaemic stroke, or arterial thromboembolism) and secondary outcomes were analysed using Cox hazard ratios (HR), adjusted for age, socioeconomic status, and comorbidities. RESULTS: 78 852 patients were included with AF, aged 40-75 years, no prior stroke, and no prescription of oral anticoagulants. 28 590 (36.3%) were women, and 50 262 (63.7%) men. Median age was 65.7 years (interquartile range 58.5-70.9), with women being older and having other differences in comorbidities. During a total follow-up of 431 086 patient-years, women had a lower adjusted primary outcome rate with HR 0.89 vs. men (95% confidence interval [CI] 0.87-0.92; P < .001) and HR 0.87 after censoring for oral anticoagulation (95% CI 0.83-0.91; P < .001). This was driven by lower mortality in women (HR 0.86, 95% CI 0.83-0.89; P < .001). No difference was identified between women and men for the secondary outcomes of ischaemic stroke or arterial thromboembolism (adjusted HR 1.00, 95% CI 0.94-1.07; P = .87), any stroke or any thromboembolism (adjusted HR 1.02, 95% CI 0.96-1.07; P = .58), and incident vascular dementia (adjusted HR 1.13, 95% CI 0.97-1.32; P = .11). Clinical risk scores were only modest predictors of outcomes, with CHA2DS2-VA (ignoring gender) superior to CHA2DS2-VASc for primary outcomes in this population (receiver operating characteristic curve area 0.651 vs. 0.639; P < .001) and no interaction with gender (P = .45). CONCLUSIONS: Removal of gender from clinical risk scoring could simplify the approach to which patients with AF should be offered oral anticoagulation.

Detection of Non-Sustained Supraventricular Tachycardia in Atrial Fibrillation Screening.

OBJECTIVE: Non-sustained supraventricular tachycardia (nsSVT) is associated with a higher risk of developing atrial fibrillation (AF), and, therefore, detection of nsSVT can improve AF screening efficiency. However, the detection is challenged by the lower signal quality of ECGs recorded using handheld devices and the presence of ectopic beats which may mimic the rhythm characteristics of nsSVT. METHODS: The present study introduces a new nsSVT detector for use in single-lead, 30-s ECGs, based on the assumption that beats in an nsSVT episode exhibits similar morphology, implying that episodes with beats of deviating morphology, either due to ectopic beats or noise/artifacts, are excluded. A support vector machine is used to classify successive 5-beat sequences in a sliding window with respect to similar morphology. Due to the lack of adequate training data, the classifier is trained using simulated ECGs with varying signal-to-noise ratio. In a subsequent step, a set of rhythm criteria is applied to similar beat sequences to ensure that episode duration and heart rate is acceptable. RESULTS: The performance of the proposed detector is evaluated using the StrokeStop II database, resulting in sensitivity, specificity, and positive predictive value of 84.6%, 99.4%, and 18.5%, respectively. CONCLUSION: The results show that a significant reduction in expert review burden (factor of 6) can be achieved using the proposed detector.Clinical and Translational Impact: The reduction in the expert review burden shows that nsSVT detection in AF screening can be made considerably more efficiently.

Large variations in atrial fibrillation screening practice after ischemic stroke and transient ischemic attack in Sweden: a survey study.

BACKGROUND: Atrial fibrillation (AF) screening after ischemic stroke or transient ischemic attack (TIA) is given high priority in clinical guidelines. However, patient selection, electrocardiogram (ECG) modality and screening duration remains undecided and current recommendations vary. METHODS: The aim of this study was to investigate the clinical practice of AF screening after ischemic stroke or TIA at Swedish stroke units. In collaboration with the stakeholders of the Swedish Stroke Register (Riksstroke) a digital survey was drafted, then tested and revised by three stroke consultants. The survey consisted of 17 multiple choice/ free text questions and was sent by e-mail to the medical directors at all stroke units in Sweden. RESULTS: All 72 stroke units in Sweden responded to the survey. Most stroke units reported that ≥ 75% of ischemic stroke (69/72 stroke units) or TIA patients (67/72 stroke units), without previously known AF, were screened for AF. Inpatient telemetry ECG was the method of first-choice in 81% of the units, but 7% reported lack of access. A variety of standard monitoring durations were used for inpatient telemetry ECG. The second most common choice was Holter ECG (17%), also with considerable variations in monitoring duration. Other AF screening modalities were used as a first-choice method (handheld and patch ECG) but less frequently. CONCLUSIONS: Clinical practice for AF screening after ischemic stroke or TIA differed between Swedish stroke units, both in choice of AF screening methods as well as in monitoring durations. There is an urgent need for evidence and evidence-based recommendations in this field. TRIAL REGISTRATION: Not applicable.

Embolic strokes of undetermined source: a clinical consensus statement of the ESC Council on Stroke, the European Association of Cardiovascular Imaging and the European Heart Rhythm Association of the ESC.

One in six ischaemic stroke patients has an embolic stroke of undetermined source (ESUS), defined as a stroke with unclear aetiology despite recommended diagnostic evaluation. The overall cardiovascular risk of ESUS is high and it is important to optimize strategies to prevent recurrent stroke and other cardiovascular events. The aim of clinicians when confronted with a patient not only with ESUS but also with any other medical condition of unclear aetiology is to identify the actual cause amongst a list of potential differential diagnoses, in order to optimize secondary prevention. However, specifically in ESUS, this may be challenging as multiple potential thromboembolic sources frequently coexist. Also, it can be delusively reassuring because despite the implementation of specific treatments for the individual pathology presumed to be the actual thromboembolic source, patients can still be vulnerable to stroke and other cardiovascular events caused by other pathologies already identified during the index diagnostic evaluation but whose thromboembolic potential was underestimated. Therefore, rather than trying to presume which particular mechanism is the actual embolic source in an ESUS patient, it is important to assess the overall thromboembolic risk of the patient through synthesis of the individual risks linked to all pathologies present, regardless if presumed causally associated or not. In this paper, a multi-disciplinary panel of clinicians/researchers from various backgrounds of expertise and specialties (cardiology, internal medicine, neurology, radiology and vascular surgery) proposes a comprehensive multi-dimensional assessment of the overall thromboembolic risk in ESUS patients through the composition of individual risks associated with all prevalent pathologies.

Validation of a novel smartphone-based photoplethysmographic method for ambulatory heart rhythm diagnostics: the SMARTBEATS study.

AIMS: In the current guidelines, smartphone photoplethysmography (PPG) is not recommended for diagnosis of atrial fibrillation (AF), without a confirmatory electrocardiogram (ECG) recording. Previous validation studies have been performed under supervision in healthcare settings, with limited generalizability of the results. We aim to investigate the diagnostic performance of a smartphone-PPG method in a real-world setting, with ambulatory unsupervised smartphone-PPG recordings, compared with simultaneous ECG recordings and including patients with atrial flutter (AFL). METHODS AND RESULTS: Unselected patients undergoing direct current cardioversion for treatment of AF or AFL were asked to perform 1-min heart rhythm recordings post-treatment, at least twice daily for 30 days at home, using an iPhone 7 smartphone running the CORAI Heart Monitor PPG application simultaneously with a single-lead ECG recording (KardiaMobile). Photoplethysmography and ECG recordings were read independently by two experienced readers. In total, 280 patients recorded 18 005 simultaneous PPG and ECG recordings. Sufficient quality for diagnosis was seen in 96.9% (PPG) vs. 95.1% (ECG) of the recordings (P < 0.001). Manual reading of the PPG recordings, compared with manually interpreted ECG recordings, had a sensitivity, specificity, and overall accuracy of 97.7%, 99.4%, and 98.9% with AFL recordings included and 99.0%, 99.7%, and 99.5%, respectively, with AFL recordings excluded. CONCLUSION: A novel smartphone-PPG method can be used by patients unsupervised at home to achieve accurate heart rhythm diagnostics of AF and AFL with very high sensitivity and specificity. This smartphone-PPG device can be used as an independent heart rhythm diagnostic device following cardioversion, without the requirement of confirmation with ECG.

Risk assessment in patients with symptomatic and asymptomatic pre-excitation.

AIMS: Controversy remains as to whether the exercise stress test (EST) is sufficient for risk evaluation in patients with pre-excitation. This study aims to clarify the usefulness of EST in risk stratification in both asymptomatic and symptomatic patients presenting with pre-excitation. METHODS AND RESULTS: This prospective study includes consecutive asymptomatic and symptomatic patients with pre-excitation referred for risk assessment. All participants performed an incremental EST (bicycle) prior to an electrophysiology study (EPS). Primary data from the EST included loss of pre-excitation during exercise, and primary data from the EPS included the measurement of accessory pathway effective refractory period (APERP), shortest pre-excited RR interval (SPERRI), and inducible arrhythmia with the use of a beta-adrenergic receptor agonist if deemed necessary. One hundred and sixty-four patients (59 asymptomatic, 105 symptomatic) completed an EST and EPS. Forty-five patients (27%) demonstrated low-risk findings on EST, of which 19 were asymptomatic and 26 were symptomatic. Six patients with low-risk EST findings had SPERRI/APERP ≤ 250 ms at EPS, and two of them were asymptomatic. The sensitivity, specificity, positive predictive value, negative predictive value (NPV), and accuracy of low-risk EST for excluding patients with SPERRI/APERP ≤ 250 ms were 40, 91, 87, 51, and 60%, respectively. The number of patients with inducible arrhythmia at EPS was similar in the asymptomatic (36, 69%) and symptomatic (73, 61%) groups. CONCLUSION: Sudden loss of pre-excitation during EST has a low NPV in excluding high-risk APs. The EPS with the use of isoproterenol should be considered to accurately assess the risk of patients with pre-excitation regardless of symptoms (ClinicalTrials.gov Identifier: NCT03301935).

Adherence to a handheld device-based atrial fibrillation screening protocol is associated with clinical outcomes.

OBJECTIVE: To evaluate adherence and adherence consistency to the handheld ECG device-based screening protocol and their association with adverse cerebral and cardiovascular outcomes in two systematic atrial fibrillation (AF) screening programmes. METHODS: In 2012 (Systematic ECG Screening for Atrial Fibrillation Among 75-Year Old Subjects in the Region of Stockholm and Halland, Sweden (STROKESTOP) study) and 2016 (Stepwise mass screening for atrial fibrillation using N-terminal pro b-type natriuretic peptide (STROKESTOP II) study), half of all 75- and 76-year-old inhabitants of up to two Swedish regions were invited to participate in a systematic AF screening programme. Participants were instructed to perform 30-second measurements twice daily in STROKESTOP and four times daily in STROKESTOP II for 2 weeks. Adherence was defined as the number of measurements performed divided by the number of measurements asked, whereas adherence consistency was defined as the number of days with complete registrations. RESULTS: In total, 6436 participants (55.7% female) from STROKESTOP and 3712 (59.8% female) from STROKESTOP II were included. Median adherence and adherence consistency were 100 (92-100)% and 12 (11-13) days in STROKESTOP and 90 (75-98)% and 8 (3-11) days in STROKESTOP II. Female sex and lower education were factors associated with both optimal adherence and adherence consistency in both studies. In STROKESTOP, low adherence and adherence consistency were associated with higher risk of adverse cerebral and cardiovascular outcomes (HR for composite primary endpoint 1.30 (1.11 to 1.51), p=0.001), including stroke (HR 1.68 (1.22 to 2.32), p=0.001) and dementia (1.67 (1.27 to 2.19), p<0.001). CONCLUSIONS: Adherence to twice daily handheld ECG measurements in STROKESTOP was higher than to four times daily measurements in STROKESTOP II. Female sex and lower educational attainment were associated with ≥100% adherence and adherence consistency. Low adherence and adherence consistency were associated with a higher risk of adverse outcomes.

Utilization of and perceived need for simulators in clinical electrophysiology: results from an EHRA physician survey.

AIMS: Simulator training has been recently introduced in electrophysiology (EP) programmes in order to improve catheter manipulation skills without complication risks. The aim of this study is to survey the current use of EP simulators and the perceived need for these tools in clinical training and practice. METHODS AND RESULTS: A 20-item online questionnaire developed by the Scientific Initiatives Committee of the European Heart Rhythm Association (EHRA) in collaboration with EHRA Digital Committee was disseminated through the EHRA Scientific Research Network members, national EP groups, and social media platforms. Seventy-four respondents from 22 countries (73% males; 50% under 40 years old) completed the survey. Despite being perceived as useful among EP professionals (81%), EP simulators are rarely a part of the institutional cardiology training programme (20%) and only 18% of the respondents have an EP simulator at their institution. When available, simulators are mainly used in EP to train transseptal puncture, ablation, and mapping, followed by device implantation (cardiac resynchronization therapy [CRT], leadless, and conduction system pacing [CSP]). Almost all respondents (96%) believe that simulator programmes should be a part of the routine institutional EP training, hopefully developed by EHRA, in order to improve the efficacy and safety of EP procedures and in particular CSP 58%, CRT 42%, leadless pacing 38%, or complex arrhythmia ablations (VT 58%, PVI 45%, and PVC 42%). CONCLUSION: This current EHRA survey identified a perceived need but a lack of institutional simulator programme access for electrophysiologists who could benefit from it in order to speed up the learning curve process and reduce complications of complex EP procedures.

Association between catheter ablation of atrial fibrillation and mortality or stroke.

OBJECTIVE: Catheter ablation of atrial fibrillation effectively reduces symptomatic burden. However, its long-term effect on mortality and stroke is unclear. We investigated if patients with atrial fibrillation who undergo catheter ablation have lower risk for all-cause mortality or stroke than patients who are managed medically. METHODS: We retrospectively included 5628 consecutive patients who underwent first-time catheter ablation for atrial fibrillation between 2008 and 2018 at three major Swedish electrophysiology units. Control individuals with an atrial fibrillation diagnosis but without previous stroke were selected from the Swedish National Patient Register, resulting in a control group of 48 676 patients. Propensity score matching was performed to produce two cohorts of equal size (n=3955) with similar baseline characteristics. The primary endpoint was a composite of all-cause mortality or stroke. RESULTS: Patients who underwent catheter ablation were healthier (mean CHA2DS2-VASc score 1.4±1.4 vs 1.6±1.5, p<0.001), had a higher median income (288 vs 212 1000 Swedish krona [KSEK]/year, p<0.001) and had more frequently received university education (45.1% vs 28.9%, p<0.001). Mean follow-up was 4.5±2.8 years. After propensity score matching, catheter ablation was associated with lower risk for the combined primary endpoint (HR 0.58, 95% CI 0.48 to 0.69). The result was mainly driven by a decrease in all-cause mortality (HR 0.51, 95% CI 0.41 to 0.63), with stroke reduction showing a trend in favour of catheter ablation (HR 0.75, 95% CI 0.53 to 1.07). CONCLUSIONS: Catheter ablation of atrial fibrillation was associated with a reduction in the primary endpoint of all-cause mortality or stroke. This result was driven by a marked reduction in all-cause mortality.

Management of modifiable risk factors and comorbidities in atrial fibrillation: suggestions for improvement from a patient perspective.

AIMS: In patients with atrial fibrillation (AF), improved management of modifiable risk factors and concomitant diseases is recommended by guidelines, yet many AF patients have sub-optimal risk factor management. Digital health solutions may offer support in this matter. This study aims to identify how patients with AF perceive they could be supported by a digital tool aimed to optimize management of comorbidities and modifiable risk factors associated with an unhealthy lifestyle. METHODS AND RESULTS: This was a qualitative, descriptive study based on four semi-structured focus-group interviews analysed by manifest content analysis. Sixteen AF patients with recent in- or outpatient encounters were included [age 68 (52-78) years; 43% female; BMI 29.5 (20.4-35.8) kg/m2; paroxysmal/persistent AF (50%/50%); AF duration 7 (0-22) years]. Relevant comorbidities were hypertension (88%), heart failure (25%), diabetes mellitus type 2 (19%), and ischaemic heart disease (13%). The patients' suggestions were summarized into three main categories. First, person-centred information is essential, meaning that information should be customized and conveyed in an appropriate manner and include practical tips. Second, patients desire help with managing lifestyle habits in a way that is applicable in everyday life, and patients desire help with creating habits. Third, regular communication is necessary including inspirational reminders and motivational feedback. CONCLUSION: Patients with AF request person-centred information, support in managing healthy lifestyle habits, and more regular communication with caregivers. This study provides a first foundation on how to better support AF patients, and using a digital tool in standard care may improve outcomes and reduce cost of care.

Multicentre, national, investigator-initiated, randomised, parallel-group, register-based superiority trial to compare extended ECG monitoring versus standard ECG monitoring in elderly patients with ischaemic stroke or transient ischaemic attack and the effect on stroke, death and intracerebral bleeding: the AF SPICE protocol.

INTRODUCTION: Atrial fibrillation (AF) is a major risk factor for ischaemic stroke and transient ischaemic attack (TIA), and AF detection can be challenged by asymptomatic and paroxysmal presentation. Long-term ECG monitoring after ischaemic stroke or TIA is recommended by all major societies in cardiology and cerebrovascular medicine as a secondary prophylactic measure. However, data on stroke reduction are lacking, and the recommendations show significant diversity. METHODS AND ANALYSIS: AF SPICE is a multicentre, national, investigator-initiated, randomised, parallel-group, register-based trial comparing extended ECG monitoring versus standard ECG monitoring in patients admitted with ischaemic stroke or TIA, with a composite endpoint of stroke, all-cause-mortality and intracerebral bleeding. Patients aged ≥70 years without previous AF will be randomised 1:1 to control (standard ECG monitoring) or intervention (extended ECG monitoring). In the control arm, patients will undergo 48±24 hours (ie, a range of 24-72 hours) of continuous ECG monitoring according to national recommendations. In the intervention arm, patients will undergo 14+14 days of continuous ECG monitoring 3 months apart using an ECG patch device, which will provide an easy-accessed, well-tolerated 14-day continuous ECG recording. All ECG patch recordings will be read in a core facility. In cases of AF detection, oral anticoagulation will be recommended if not contraindicated. A pilot phase has been concluded in 2022, which will transcend into the main trial during 2023-2026, including approximately 30 stroke units. The sample size was calculated to be 3262 patients. The primary outcome will be collected from register data during a 36-month follow-up. ETHICS AND DISSEMINATION: Ethical approval has been provided by the Swedish Ethical Review Authority, reference 2021-02770. The trial will be conducted according to the ethical principles of the Declaration of Helsinki and national regulatory standards. Positive results from the study have the potential for rapid dissemination in clinical practice. TRIAL REGISTRATION NUMBER: NCT05134454.