Enhanced Detection of Underlying, Covert ATrial Fibrillation Using 7-day Holter Electrocardiogram in Patients With Embolic Stroke of Undetermined Source

• Conditions: Stroke

• Registration Number: NCT02801708
• Lead Sponsor: National Cerebral and Cardiovascular Center, Japan

Brief Summary

The aim of this study is to determine the diagnostic yield of continuous 7-day Holter ECG for detecting covert paroxysmal atrial fibrillation in patients with recent embolic stroke or transient ischemic attack (TIA) of undetermined cause after completion of a standard clinical work up including an initial 24-hour Holter monitoring.

Detailed Description

Covert atrial fibrillation (AF) is a relevant potential cause of a recently proposed clinical construct, "Embolic Stroke of Undetermined Source (ESUS)". However, routine post-stroke work up including 24-hour Holter monitoring may fail to detect paroxysmal AF. A recent systematic review has shown an increased AF detection rate with longer monitoring durations. The aim of this study is to evaluate the effectiveness of a novel ambulatory 7-day Holter ECG (EV-201, Parama-Tech inc.) for detecting AF in patients with recent ESUS after completion of a standard clinical examination.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2016-06-04
• Study First Submitted QC: 2016-06-13
• Study First Posted: 2016-06-16
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-01
• Last Update Posted: 2016-12-02
• Primary Completion: 2018-03
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Recent ESUS (within 3 months of onset) defined as:

   A. Recent ischemic stroke (including transient ischemic attack with positive neuroimaging) visualized by brain imaging that is not lacunar B. Abscence of ≥ 50% stenosis or occlusion in cervical and intracranial arteries supplying ischemic area C. No atrial fibrillation after ≥ 24-hour Holter monitoring D. No intra-cardiac thrombus on transthoracic echocardiography E. No other major cardioembolic sources F. No other specific cause of stroke (for example, arteritis, dissection, migraine/vasospasm, drug abuse)

2. 20 years of age or older

3. Signed written informed consent

Exclusion Criteria

1. Previously documented atrial fibrillation
2. Untreated hyperthyroidism
3. Pacemaker or implantable cardioverter defibrillator implanted or planned to implant
4. Estimated life expectancy < 12 months
5. Examination of seven-day Holter ECG not applicable within 3 months after stroke onset.
6. Patients considered inappropriate to participate in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection of any atrial fibrillation	After examination of 7-day Holter monitoring (within 90 days of stroke onset)

Secondary Outcome Measures

Name	Time	Method
Change of antithrombotic drugs	After the examination of 7-day Holter monitoring
Any adverse event related to 7-day Holter monitoring	After the examination of 7-day Holter monitoring
Time to detection of atrial fibrillation on 7-day Holter monitoring	After the examination of 7-day Holter monitoring
Any ischemic or hemorrhagic event	365 days after index stroke
Atrial fibrillation burden	After the examination of 7-day Holter monitoring	defined as the total time in atrial fibrillation devided by the total monitored time

Trial Locations

Locations (1)

National Cerebral and Cardiovascular Center; 🇯🇵 Suita, Osaka, Japan