Detection of Occult Paroxysmal Atrial Fibrillation After Stroke Using Prolonged Ambulatory Cardiac Monitoring

Completed

Phase N/A Results N/A

Trial Description

About one-third of patients with stroke have no documented cause for the cerebrovascular event (known as cryptogenic strokes). Atrial fibrillation is a common cause of stroke, but when transient (paroxysmal) it may remain undiagnosed. Recent data suggest that occult paroxysmal atrial fibrillation may be identified in patients with cryptogenic strokes using prolonged ambulatory cardiac rhythm monitors.
The investigators designed this study pursuing the following goals:
1. To determine the prevalence of occult paroxysmal atrial fibrillation in patients with cryptogenic stroke using long-term mobile cardiac outpatient telemetry.
2. To compare this prevalence to that found in a control group with stroke of known, non-cardioembolic cause.
3. To look for clinical, laboratory, echocardiographic, and imaging data that serve as risk factors for occult paroxysmal atrial fibrillation in patients with cryptogenic stroke.
4. To examine the utility of mobile cardiac outpatient telemetry, a relatively new diagnostic tool, in the evaluation of patients with cryptogenic stroke.

Conditions

Interventions

  • Mobile cardiac rhythm monitoring Other
    Intervention Desc: Continuous ambulatory cardiac rhythm monitoring using the CardioNet MCOT device
    ARM 1: Kind: Experimental
    Label: Cryptogenic stroke
    Description: Patients with stroke of unknown cause after comprehensive conventional evaluation
    ARM 2: Kind: Experimental
    Label: Stroke of known cause
    Description: Patients with stroke of known cause determined by comprehensive conventional evaluation

Trial Design

  • Observation: Case Control
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial Population

Patients with stroke or TIA confirmed by a vascular neurologist within previous 3 months with complete evaluation for stroke causes according to current standards.

Outcomes

Type Measure Time Frame Safety Issue
Primary Detection of Atrial Fibrillation 21 days No
Secondary Time to first episode of atrial fibrillation No
Secondary Atrial Fibrillation Load No
Secondary Adverse events related to mobile cardiac monitoring 21 days Yes
Secondary Symptomatic status of episode of atrial fibrillation 21 days No
Secondary Longest duration of episode of atrial fibrillation 21 days No

Sponsors