30-Day Cardiac Event Monitor Belt for Recording Atrial Fibrillation After a Cerebral Ischemic Event "EMBRACE"

Active, not recruiting

Phase N/A Results N/A

Trial Description

Atrial fibrillation is the most common cardiac cause of ischemic stroke. Detecting atrial fibrillation after a stroke or TIA is critical because highly effective secondary stroke prevention therapy is available for individuals who are recognized to have atrial fibrillation. However, atrial fibrillation is likely under-diagnosed after stroke and TIA because atrial fibrillation is often difficult to detect as it is frequently paroxysmal and asymptomatic, and patients do not routinely undergo prolonged screening. The purpose of this study is to determine the diagnostic yield of a novel 30-day cardiac event monitor compared to a repeat 24-hour Holter monitor for detecting occult paroxysmal atrial fibrillation in patients with a recent ischemic stroke or TIA of undetermined etiology after completion of a standard clinical stroke work-up (including an initial negative Holter monitor.)

Conditions

Interventions

  • A 30-day ambulatory cardiac event monitor Device
    Other Names: AccuHeart Electrode Belt, Braemar ER 910AF (cardiac event monitor)
    Intervention Desc: Patients will be fitted with dry electrode belt (including cardiac event monitor)and instructed to wear the device for as many hours(waking and sleeping) each day as possible, for a total of 30 days.
    ARM 1: Kind: Experimental
    Label: 30-day ambulatory cardiac event monitor
  • 24-hour Holter Device
    Other Names: Performed as per individual hospital routines
    Intervention Desc: Repeat standard 24-hour Holter Monitor
    ARM 1: Kind: Experimental
    Label: repeat 24-hour Holter monitor

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Diagnostic
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Detection of one or more episodes of atrial fibrillation or atrial flutter ≥30 seconds, as assessed at the 90 day follow-up 90 days No
Secondary Atrial fibrillation <30 seconds 90 days No
Secondary Atrial flutter <30 seconds 90 days No
Secondary Non-sustained (>3 beats, <30 seconds) irregular atrial tachyarrhythmia (including brief runs of atrial fibrillation) 90 days No
Secondary Proportion of patients in each group that are prescribed oral anticoagulation, as assessed at the 90-day follow-up 90 days No
Secondary Patient adherence with 30-day monitoring: average proportion of days wearing the monitor per patient, and the percentage of patients wearing the monitor for >75% of the target period 90 days No
Secondary 1 and 2-year recurrence of ischemic stroke/TIA, death, hemorrhagic stroke, major adverse bleeding event, detection of atrial fibrillation outside of the study protocol 2 years No
Secondary composite endpoint of: (1) AF >30 seconds, (2) non-sustained (>3 beats, <30 seconds) irregular atrial tachyarrhythmia (including brief runs of AF), or (3) atrial flutter. 90 days No

Sponsors