Long-term Cardiac Monitoring After Cryptogenic Stroke (CMACS)

NCT ID: NCT00932425

Last Updated: 2015-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2011-05-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Outpatient cardiac monitoring

Patients will be assigned to wear a portable outpatient cardiac telemetry device for 21 days

Group Type: EXPERIMENTAL

Cardionet Mobile Cardiac Outpatient Telemetry (MCOT)

Intervention Type: DEVICE

Patients will be assigned to wear the telemetry device for 21 days

Control

Patients will be discharged home with standard clinical follow-up

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cardionet Mobile Cardiac Outpatient Telemetry (MCOT)

Patients will be assigned to wear the telemetry device for 21 days

Intervention Type: DEVICE

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wade Smith, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

CMACS

Identifier Type: -

Identifier Source: org_study_id