Clinical trial NCT02801708: Enhanced Detection of Underlying, Covert ATrial Fibrillation Using 7-day Holter Electrocardiogram in Patients With Embolic Stroke of Undetermined Source
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Keywords: Embolic stroke of undetermined source
Atrial fibrillation
Lead sponsor: National Cerebral and Cardiovascular Center, Japan
Sponsor class: OTHER
First posted: 2016-06-16
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with recent embolic stroke of undetermined source

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.

Eligibility 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

Primary outcomes:
measure: Detection of any atrial fibrillation
timeFrame: After examination of 7-day Holter monitoring (within 90 days of stroke onset)
Secondary outcomes:
measure: Change of antithrombotic drugs
timeFrame: After the examination of 7-day Holter monitoring
measure: Any ischemic or hemorrhagic event
timeFrame: 365 days after index stroke
measure: Any adverse event related to 7-day Holter monitoring
timeFrame: After the examination of 7-day Holter monitoring
measure: Time to detection of atrial fibrillation on 7-day Holter monitoring
timeFrame: After the examination of 7-day Holter monitoring
measure: Atrial fibrillation burden
timeFrame: After the examination of 7-day Holter monitoring
Other outcomes:
Locations:
city: Suita
country: Japan
facility: National Cerebral and Cardiovascular Center
state: Osaka
Study officials:
affiliation: National Cerebral and Cardiovascular Center, Japan
name: Yuichi Miyazaki, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.