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

Stroke Clinical Trial

— EDUCATE-ESUS  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02801708
• Other study ID #: NCVC-M27-017
• Status: Recruiting
• Phase: N/A
• First received: June 4, 2016
• Last updated: December 1, 2016
• Start date: August 2014
• Est. completion date: March 2019

Study information

• Verified date: December 2016
• Source: National Cerebral and Cardiovascular Center
• Contact: Yuichi Miyazaki, MD
• Phone: 81-6-6833-5012
• Email: ymiyazaki[@]ncvc.go.jp
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 2019
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke

Locations

Country	Name	City	State
Japan	National Cerebral and Cardiovascular Center	Suita	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
National Cerebral and Cardiovascular Center

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of any atrial fibrillation		After examination of 7-day Holter monitoring (within 90 days of stroke onset)	No
Secondary	Change of antithrombotic drugs		After the examination of 7-day Holter monitoring	No
Secondary	Any ischemic or hemorrhagic event		365 days after index stroke	Yes
Secondary	Any adverse event related to 7-day Holter monitoring		After the examination of 7-day Holter monitoring	Yes
Secondary	Time to detection of atrial fibrillation on 7-day Holter monitoring		After the examination of 7-day Holter monitoring	No
Secondary	Atrial fibrillation burden	defined as the total time in atrial fibrillation devided by the total monitored time	After the examination of 7-day Holter monitoring	No