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

Recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Trial Design

  • Observation: Case-Only
  • Perspective: Prospective
  • Sampling: Probability Sample

Trial Population

Patients with recent embolic stroke of undetermined source

Outcomes

Type Measure 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 After the examination of 7-day Holter monitoring No

Sponsors