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

December 1, 2016 updated by: Yuichi Miyazaki, National Cerebral and Cardiovascular Center
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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
    • Osaka
      • Suita, Osaka, Japan, 565-8565
        • Recruiting
        • National Cerebral and Cardiovascular Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with recent embolic stroke of undetermined source

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Detection of any atrial fibrillation
Time Frame: After examination of 7-day Holter monitoring (within 90 days of stroke onset)
After examination of 7-day Holter monitoring (within 90 days of stroke onset)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cerebral and Cardiovascular Center

Investigators

  • Principal Investigator: Yuichi Miyazaki, MD, National Cerebral and Cardiovascular Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

June 4, 2016

First Submitted That Met QC Criteria

June 13, 2016

First Posted (Estimate)

June 16, 2016

Study Record Updates

Last Update Posted (Estimate)

December 2, 2016

Last Update Submitted That Met QC Criteria

December 1, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCVC-M27-017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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