Smartwatches for Detection of Atrial Fibrillation (AFib) in Secondary Prevention of Cryptogenic Stroke

NCT06005233 | Recruiting DMC

• 1 other identifier: 20230726
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Scientific Background: In secondary prevention of ischemic stroke, detection of atrial fibrillation (AFib) and subsequent anticoagulation therapy reduce the risk of recurrent stroke by approximately 60%. Prolonged electrocardiogram (ECG) monitoring up to 6 months significantly increases detection of AFib in cryptogenic stroke. Wearables like smartwatches have recently been shown to adequately detect AFib in the general population. Thus, prolonged ECG monitoring after cryptogenic ischemic stroke or transient ischemic attack (TIA) using a smartwatch could lead to a reduction of recurrent stroke by prompting adequate anticoagulation therapy and may constitute a cost-effective, non-invasive, and broadly-available alternative to the current standard of care. Hypothesis: The investigators hypothesize that AFib detection via smartwatch in patients with cryptogenic TIA or ischemic stroke is accurate compared to an implantable event recorder. Methods: The investigators introduce a prospective, intraindividual-controlled, multicentre clinical study in patients with cryptogenic ischemic stroke or TIA. In addition to an implanted event recorder as indicated by clinical standard, included patients receive a smartwatch for detection of AFib. ECG-data from smartwatches will be continuously monitored by two independent cardiologists. As soon as AFib is confirmed, a doctoral appointment is set to evaluate start of anticoagulation. The follow-up period will be six months. The study consists of four study visits: a baseline visit, two phone visits at one and three months, and an end of trial visit at six months. Primary Objective: To compare smartwatch and event recorder based analysis for sensitivity and specificity of AFib detection per patient after six months

Conditions

Ischemic Stroke, Cryptogenic; Transient Ischemic Attack; Atrial Fibrillation

Keywords

Smartwatch; Ischemic stroke; atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• Sensitivity and Specificity of AFib Detection

  To estimate and compare sensitivity and specificity for AFib detection per patient after six months (Comparison of smartwatch based, continuous, automated, cardiologist supervised rhythm analysis of photoplethysmography (PPG)- signal and patient activated 1-lead ECG with Event Recorder based, continuous, automated ECG rhythm analysis).

  From baseline visit (V0) to the last follow-up at visit (V3) at six months

Secondary Outcomes (13)

• To estimate and compare the positive and negative predictive values for AFib detection per patient

  From baseline visit (V0) to the last follow-up at visit (V3) at six months

• Sensitivity and specificity for AFib detection of the automated PPG-signal rhythm analysis

  From baseline visit (V0) to the last follow-up at visit (V3) at six months

• Sensitivity and specificity for the detection of any AFib episode

  From baseline visit (V0) to the last follow-up at visit (V3) at six months

• Sensitivity for the detection of AFib episodes >1 hour

  From baseline visit (V0) to the last follow-up at visit (V3) at six months

• Sensitivity and specificity of AFib detection per recorded/ per analyzable time (i.e., intervals in which the watch is actually worn/records an analyzable signal; per-protocol analysis)

  From baseline visit (V0) to the last follow-up at visit (V3) at six months

Study Arms (1)

Application of Smartwatch

EXPERIMENTAL

Application of smartwatch in addition to an implanted event recorder. Follow-up of 6 months

Device: Smartwatch

Interventions

Smartwatch DEVICE

Smartwatch with PPG- and 1-lead ECG derived analysis of cardiac arrhythmia. Analysis will be performed centrally at the Cardiology Core Lab at the Klinikum Rechts der Isar.

Application of Smartwatch

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Implanted Event Recorder with telemedicinal function (e.g., Biotronik BioMon 3m ProMRI HomeMon or similar)
• Cryptogenic stroke (within the last six month) after full standard evaluation:
• Stroke detected by computed tomography (CT) or magnetic resonance imaging (MRI) that is not lacunar (lacunar is defined as a subcortical infarct in the distribution of the small, penetrating cerebral arteries whose largest dimension is ≤1.5 cm on CT or ≤2.0 cm on MRI diffusion images)
• Absence of extracranial or intracranial atherosclerosis causing ≥50 percent luminal stenosis of the artery supplying the area of ischemia
• No major-risk cardioembolic source of embolism (i.e., no permanent or paroxysmal atrial fibrillation, sustained atrial flutter, intracardiac thrombus, prosthetic cardiac valve, atrial myxoma or other cardiac tumors, high-grade mitral valve stenosis, recent (within four weeks) myocardial infarction, left ventricular ejection fraction \<30 percent, valvular vegetations, or infective endocarditis)
• No other specific cause of stroke identified (e.g., arteritis, dissection, migraine, vasospasm, drug abuse)
• No paroxysmal atrial fibrillation in 72h of in-hospital ECG-monitoring, including at least one Holter- ECG for 24 hours.
• Cryptogenic TIA with definite cortical syndrome (aphasia, neglect or homonymous hemianopia) (within the last six month) after full standard evaluation (see above)
• Age: ≥40 yrs.
• At least one of the following risk factors:
• CHA2DS2VASc score ≥4
• Atrial runs
• Left atrial size \> 45mm
• Left atrial appendage flow ≤ 0.2m/s
• No contraindication for anticoagulant therapy after acute phase of stroke

You may not qualify if:

• Patient is not able to perform 1-lead ECG recording with smartwatch
• Patient possesses no smartphone (iOS version ≥10.0 or Android)
• Implanted pacemaker or cardioverter defibrillator (ICD)
• Pregnancy and breastfeeding period

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Klinikum rechts der Isar, Technische Universität München

Munich, 81675, Germany

RECRUITING

Related Publications (14)

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• Secondary prevention in non-rheumatic atrial fibrillation after transient ischaemic attack or minor stroke. EAFT (European Atrial Fibrillation Trial) Study Group. Lancet. 1993 Nov 20;342(8882):1255-62.

  PMID: 7901582 BACKGROUND

• Hart RG, Pearce LA, Koudstaal PJ. Transient ischemic attacks in patients with atrial fibrillation: implications for secondary prevention: the European Atrial Fibrillation Trial and Stroke Prevention in Atrial Fibrillation III trial. Stroke. 2004 Apr;35(4):948-51. doi: 10.1161/01.STR.0000120741.34866.1D. Epub 2004 Feb 26.

  PMID: 14988571 BACKGROUND

• Hart RG, Diener HC, Coutts SB, Easton JD, Granger CB, O'Donnell MJ, Sacco RL, Connolly SJ; Cryptogenic Stroke/ESUS International Working Group. Embolic strokes of undetermined source: the case for a new clinical construct. Lancet Neurol. 2014 Apr;13(4):429-38. doi: 10.1016/S1474-4422(13)70310-7.

  PMID: 24646875 BACKGROUND

• Sanna T, Diener HC, Passman RS, Di Lazzaro V, Bernstein RA, Morillo CA, Rymer MM, Thijs V, Rogers T, Beckers F, Lindborg K, Brachmann J; CRYSTAL AF Investigators. Cryptogenic stroke and underlying atrial fibrillation. N Engl J Med. 2014 Jun 26;370(26):2478-86. doi: 10.1056/NEJMoa1313600.

  PMID: 24963567 BACKGROUND

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  PMID: 24963566 BACKGROUND

• Tsivgoulis G, Katsanos AH, Mac Grory B, Kohrmann M, Ricci BA, Tsioufis K, Cutting S, Krogias C, Schellinger PD, Campello AR, Cuadrado-Godia E, Gladstone DJ, Sanna T, Wachter R, Furie K, Alexandrov AV, Yaghi S. Prolonged Cardiac Rhythm Monitoring and Secondary Stroke Prevention in Patients With Cryptogenic Cerebral Ischemia. Stroke. 2019 Aug;50(8):2175-2180. doi: 10.1161/STROKEAHA.119.025169. Epub 2019 Jun 20.

  PMID: 31216964 BACKGROUND

• Perez MV, Mahaffey KW, Hedlin H, Rumsfeld JS, Garcia A, Ferris T, Balasubramanian V, Russo AM, Rajmane A, Cheung L, Hung G, Lee J, Kowey P, Talati N, Nag D, Gummidipundi SE, Beatty A, Hills MT, Desai S, Granger CB, Desai M, Turakhia MP; Apple Heart Study Investigators. Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation. N Engl J Med. 2019 Nov 14;381(20):1909-1917. doi: 10.1056/NEJMoa1901183.

  PMID: 31722151 BACKGROUND

• Tison GH, Sanchez JM, Ballinger B, Singh A, Olgin JE, Pletcher MJ, Vittinghoff E, Lee ES, Fan SM, Gladstone RA, Mikell C, Sohoni N, Hsieh J, Marcus GM. Passive Detection of Atrial Fibrillation Using a Commercially Available Smartwatch. JAMA Cardiol. 2018 May 1;3(5):409-416. doi: 10.1001/jamacardio.2018.0136.

  PMID: 29562087 BACKGROUND

• Dorr M, Nohturfft V, Brasier N, Bosshard E, Djurdjevic A, Gross S, Raichle CJ, Rhinisperger M, Stockli R, Eckstein J. The WATCH AF Trial: SmartWATCHes for Detection of Atrial Fibrillation. JACC Clin Electrophysiol. 2019 Feb;5(2):199-208. doi: 10.1016/j.jacep.2018.10.006. Epub 2018 Nov 28.

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  PMID: 31113234 BACKGROUND

• Afzal MR, Gunda S, Waheed S, Sehar N, Maybrook RJ, Dawn B, Lakkireddy D. Role of Outpatient Cardiac Rhythm Monitoring in Cryptogenic Stroke: A Systematic Review and Meta-Analysis. Pacing Clin Electrophysiol. 2015 Oct;38(10):1236-45. doi: 10.1111/pace.12688. Epub 2015 Aug 27.

  PMID: 26172621 BACKGROUND

• Ding EY, CastanedaAvila M, Tran KV, Mehawej J, Filippaios A, Paul T, Otabil EM, Noorishirazi K, Han D, Saczynski JS, Barton B, Mazor KM, Chon K, McManus DD. Usability of a smartwatch for atrial fibrillation detection in older adults after stroke. Cardiovasc Digit Health J. 2022 Apr 18;3(3):126-135. doi: 10.1016/j.cvdhj.2022.03.003. eCollection 2022 Jun.

  PMID: 35720675 BACKGROUND

• Poli S, Diedler J, Hartig F, Gotz N, Bauer A, Sachse T, Muller K, Muller I, Stimpfle F, Duckheim M, Steeg M, Eick C, Schreieck J, Gawaz M, Ziemann U, Zuern CS. Insertable cardiac monitors after cryptogenic stroke--a risk factor based approach to enhance the detection rate for paroxysmal atrial fibrillation. Eur J Neurol. 2016 Feb;23(2):375-81. doi: 10.1111/ene.12843. Epub 2015 Oct 16.

  PMID: 26470854 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke; Ischemic Attack, Transient; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Silke Wunderlich, Dr.med

CONTACT

0049(0)8941404606; Silke.Wunderlich@tum.de

Horst Penkert, Dr. med.

CONTACT

0049(0)8941404606; h.penkert@tum.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, intraindividual-controlled, multicenter clinical study.

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 22, 2023
• Study Start: October 15, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 13, 2024

Record last verified: 2024-11

Locations

DE (1)