Smartphone Electrocardiogram for Recording Atrial Fibrillation After a Cerebral Ischemic Event — SMART-AF  

Stroke Clinical Trial

Official title: Smartphone Electrocardiogram for Recording Atrial Fibrillation After a Cerebral Ischemic Event: A Randomised Controlled Trial

Status Completed

Clinical Trial Summary

To determine the diagnostic yield of a 30-day smartphone electrocardiogram recording compared to 24-hour Holter monitor for detecting occult paroxysmal atrial fibrillation in patients with a recent ischemic stroke or transient ischemic attack of undetermined etiology after completion of a standard clinical stroke work-up.

Clinical Trial Description

Study outcomes

Primary:

Detection of one or more episodes of atrial fibrillation or atrial flutter ≥30 seconds as assessed at the 30 day follow-up.

Secondary:

1. Proportion of patients prescribed oral anticoagulation, as assess at the 30-day follow up.

2. Patient adherence with 30-day smartphone ECG monitoring, and percentage of patients using the monitor >75% of the target in 30-day period

3. Time to first detection of AF within 30 days (days)

4. One year rate of recurrent ischemic stroke or transient ischemic attack, death, hemorrhagic stroke, major adverse bleeding events, detection of AF outside the study protocol.

Exploratory:

To explore the feasibility and cost effectiveness of 30-day smartphone ECG recording for detecting occult paroxysmal atrial fibrillation ;

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke

• NCT number: NCT04332718
• Study type: Interventional
• Source: Sarawak Heart Centre
• Status: Completed
• Phase: N/A
• Start date: November 15, 2017
• Completion date: July 30, 2021