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

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ClinicalTrials.gov Identifier: NCT02801708
Recruitment Status : Unknown
Verified December 2016 by Yuichi Miyazaki, National Cerebral and Cardiovascular Center.
Recruitment status was:  Recruiting
First Posted : June 16, 2016
Last Update Posted : December 2, 2016
Sponsor:
Information provided by (Responsible Party):
Yuichi Miyazaki, National Cerebral and Cardiovascular Center

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.

Condition or disease
Stroke

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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : August 2014
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Detection of any atrial fibrillation [ Time Frame: After examination of 7-day Holter monitoring (within 90 days of stroke onset) ]

Secondary Outcome Measures :
  1. Change of antithrombotic drugs [ Time Frame: After the examination of 7-day Holter monitoring ]
  2. Any ischemic or hemorrhagic event [ Time Frame: 365 days after index stroke ]
  3. Any adverse event related to 7-day Holter monitoring [ Time Frame: After the examination of 7-day Holter monitoring ]
  4. Time to detection of atrial fibrillation on 7-day Holter monitoring [ Time Frame: After the examination of 7-day Holter monitoring ]
  5. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with recent embolic stroke of undetermined source
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02801708


Contacts
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Contact: Yuichi Miyazaki, MD 81-6-6833-5012 ymiyazaki@ncvc.go.jp

Locations
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Japan
National Cerebral and Cardiovascular Center Recruiting
Suita, Osaka, Japan, 565-8565
Contact: Yuichi Miyazaki, MD    81-6-6833-5012    ymiyazaki@ncvc.go.jp   
Contact: Kazunori Toyoda, MD, PhD    81-6-6833-5012    toyoda@ncvc.go.jp   
Sponsors and Collaborators
National Cerebral and Cardiovascular Center
Investigators
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Principal Investigator: Yuichi Miyazaki, MD National Cerebral and Cardiovascular Center
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Responsible Party: Yuichi Miyazaki, Principal Investigator, National Cerebral and Cardiovascular Center
ClinicalTrials.gov Identifier: NCT02801708    
Other Study ID Numbers: NCVC-M27-017
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: December 2, 2016
Last Verified: December 2016
Keywords provided by Yuichi Miyazaki, National Cerebral and Cardiovascular Center:
Embolic stroke of undetermined source
Atrial fibrillation
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases