Long-term Cardiac Monitoring After Cryptogenic Stroke (CMACS)

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: Cardionet Mobile Cardiac Outpatient Telemetry (MCOT)

• Registration Number: NCT00932425
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2009-07-01
• Study First Submitted QC: 2009-07-02
• Study First Posted: 2009-07-03
• Study Start: 2009-09
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2015-02
• Results First Submitted: 2015-02-12
• Results First Submitted QC: 2015-02-12
• Last Update Submitted: 2015-02-12
• Results First Posted: 2015-02-27
• Last Update Posted: 2015-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age > 18 years
• Seen at UCSF Medical Center for cryptogenic stroke or high-risk TIA
• Onset of stroke or TIA symptoms within the previous 60 days

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Exclusion Criteria

• Definite small-vessel etiology by history or imaging
• Source found on vascular imaging of possible culprit vessels
• Source found by echocardiography (TEE not required)
• History of atrial fibrillation
• Atrial fibrillation on admission ECG
• Atrial fibrillation detected by inpatient cardiac telemetry (at least 24 hours required)
• Obvious culpable systemic illness such as endocarditis
• Patient unable to provide written, informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Outpatient cardiac monitoring	Cardionet Mobile Cardiac Outpatient Telemetry (MCOT)	Patients will be assigned to wear a portable outpatient cardiac telemetry device for 21 days

Primary Outcome Measures

Name	Time	Method
Completion of Clinical Follow-up as a Measure of Feasibility	1 year	Feasibility was defined as 90% or more of randomized patients completing full clinical follow-up and 70% or more completion of assigned cardiac monitoring if applicable
Completion of Assigned Monitoring as a Measure of Feasibility	21 days	Feasibility criteria included more than 70% completion of cardiac monitoring if applicable. Patients in the Monitoring arm were assigned to wear a Cardionet mobile cardiac outpatient telemetry monitor for 21 days. Outpatient monitoring began 22 days (+/- 12 days) after symptom onset.

Secondary Outcome Measures

Name	Time	Method
Diagnosis of Atrial Fibrillation	1 year
Recurrent Stroke or TIA	1 year	Patients and their primary physicians or neurologists were contacted at 3 months and 1 year after discharge and reported clinical diagnoses of recurrent stroke or TIA using validated questionnaires. Reported events were verified by review of relevant medical records.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States