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

NCT02801708 | Unknown

• 1 other identifier: NCVC-M27-017
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Embolic stroke of undetermined source; Atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• Detection of any atrial fibrillation

  After examination of 7-day Holter monitoring (within 90 days of stroke onset)

Secondary Outcomes (5)

• Change of antithrombotic drugs

  After the examination of 7-day Holter monitoring

• Any ischemic or hemorrhagic event

  365 days after index stroke

• 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

• Atrial fibrillation burden

  After the examination of 7-day Holter monitoring

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with recent embolic stroke of undetermined source

You may qualify if:

• 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)
• years of age or older
• Signed written informed consent

You may not qualify if:

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

Sponsors & Collaborators

• National Cerebral and Cardiovascular Center, Japan: lead

Study Sites (1)

National Cerebral and Cardiovascular Center

Suita, Osaka, 565-8565, Japan

RECRUITING

Related Publications (1)

• Miyazaki Y, Toyoda K, Iguchi Y, Hirano T, Metoki N, Tomoda M, Shiozawa M, Koge J, Okada Y, Terasawa Y, Kikuno M, Okano H, Hagii J, Nakajima M, Komatsu T, Yasaka M. Atrial Fibrillation After Ischemic Stroke Detected by Chest Strap-Style 7-Day Holter Monitoring and the Risk Predictors: EDUCATE-ESUS. J Atheroscler Thromb. 2021 May 1;28(5):544-554. doi: 10.5551/jat.58420. Epub 2020 Aug 15.

  PMID: 32801289 DERIVED

MeSH Terms

Conditions

Stroke; Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Yuichi Miyazaki, MD

  National Cerebral and Cardiovascular Center, Japan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuichi Miyazaki, MD

CONTACT

81-6-6833-5012; ymiyazaki@ncvc.go.jp

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 4, 2016
• First Posted: June 16, 2016
• Study Start: August 1, 2014
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2019
• Last Updated: December 2, 2016

Record last verified: 2016-12

Locations

JP (1)