Long-term Cardiac Monitoring After Cryptogenic Stroke (CMACS) "CMACS"

Completed

Phase N/A Results

Trial Description

Atrial fibrillation (AF) is a common and treatable cause of ischemic stroke, but it can be paroxysmal and asymptomatic, and therefore difficult to detect. Patients with stroke routinely undergo 24 hours of continuous cardiac telemetry during hospitalization for stroke as a means of excluding AF. Small studies indicate that extending the duration of monitoring with portable outpatient telemetry devices detects more cases of AF. However, these studies are small and lack control groups, and cannot demonstrate that prolonged cardiac monitoring detects more cases of AF than routine clinical follow-up. The investigators therefore propose a pilot study to determine the feasibility of randomizing patients to prolonged cardiac monitoring or routine clinical follow-up. The investigators will enroll 40 consecutive adult patients seen at the University of California at San Francisco (UCSF) Neurovascular service with cryptogenic stroke or high-risk TIA (ABCD2 score 4 or greater). Enrolled patients will be randomized in a 1:1 fashion. Group A will be assigned to wear an ambulatory cardiac event monitor for 21 days. Group B will be discharged home without a monitor and will serve as controls during routine clinical follow-up. The investigators' primary outcome will be feasibility, defined as more than 80% of randomized patients completing full clinical follow-up and more than 70% of cardiac monitoring if applicable. The investigators' secondary outcomes will be diagnoses of AF at 90 days and 1 year and diagnoses of recurrent stroke at 1 year.

Conditions

Interventions

  • Cardionet Mobile Cardiac Outpatient Telemetry (MCOT) Device
    Other Names: Cardionet Mobile Cardiac Outpatient Telemetry (MCOT)
    Intervention Desc: Patients will be assigned to wear the telemetry device for 21 days
    ARM 1: Kind: Experimental
    Label: Outpatient cardiac monitoring
    Description: Patients will be assigned to wear a portable outpatient cardiac telemetry device for 21 days

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Feasibility, defined as more than 80% of randomized patients completing full clinical follow-up and more than 70% of cardiac monitoring if applicable 1 year No
Secondary Diagnosis of atrial fibrillation 90 days No
Secondary Recurrent stroke 1 year No
Primary Completion of Clinical Follow-up as a Measure of Feasibility 1 year No
Primary Completion of Assigned Monitoring as a Measure of Feasibility 21 days No
Secondary Recurrent Stroke or TIA 1 year Yes

Sponsors