NCT02801708

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: National Cerebral and Cardiovascular Center, Japan · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke

Timeline

• Start date: 2014-08-01
• Primary completion: 2018-03-01
• Completion: 2019-03-01
• First posted: 2016-06-16
• Last updated: 2016-12-02

Locations

1 site across 1 country: Japan