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| Sponsor: | University of California, San Francisco |
|---|---|
| Information provided by: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00932425 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Stroke |
Device: Cardionet Mobile Cardiac Outpatient Telemetry (MCOT) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Long-term Cardiac Monitoring After Cryptogenic Stroke (CMACS): A Pilot Randomized Trial |
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | May 2012 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Outpatient cardiac monitoring
Patients will be assigned to wear a portable outpatient cardiac telemetry device for 21 days
|
Device: Cardionet Mobile Cardiac Outpatient Telemetry (MCOT)
Patients will be assigned to wear the telemetry device for 21 days
Other Name: Cardionet Mobile Cardiac Outpatient Telemetry (MCOT)
|
|
No Intervention: Control
Patients will be discharged home with standard clinical follow-up
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| University of California, San Francisco | |
| San Francisco, California, United States, 94143 | |
| Principal Investigator: | Wade Smith, MD, PhD | University of California, San Francisco |
More Information
| Responsible Party: | Wade Smith, MD, PhD, University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00932425 History of Changes |
| Other Study ID Numbers: | CMACS |
| Study First Received: | July 1, 2009 |
| Last Updated: | July 18, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Stroke Cryptogenic Cardioembolic Atrial Fibrillation |
|
Stroke Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |