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

• ClinicalTrials.gov Identifier: NCT00932425
• Recruitment Status: Completed
• First Posted: July 3, 2009
• Results First Posted: February 27, 2015
• Last Update Posted: February 27, 2015
• Sponsor: University of California, San Francisco
• Information provided by (Responsible Party): University of California, San Francisco

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Stroke	Device: Cardionet Mobile Cardiac Outpatient Telemetry (MCOT)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Long-term Cardiac Monitoring After Cryptogenic Stroke (CMACS): A Pilot Randomized Trial
• Study Start Date: September 2009
• Actual Primary Completion Date: May 2011
• Actual Study Completion Date: May 2011

Arms and Interventions

Arm	Intervention/treatment
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
No Intervention: Control; Patients will be discharged home with standard clinical follow-up

Outcome Measures

Primary Outcome Measures :

1. Completion of Clinical Follow-up as a Measure of Feasibility [ Time Frame: 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
2. Completion of Assigned Monitoring as a Measure of Feasibility [ Time Frame: 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 :

1. Diagnosis of Atrial Fibrillation [ Time Frame: 90 days ]
2. Diagnosis of Atrial Fibrillation [ Time Frame: 1 year ]
3. Recurrent Stroke or TIA [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, California

University of California, San Francisco

San Francisco, California, United States, 94143

Sponsors and Collaborators

University of California, San Francisco

Investigators

• Principal Investigator: Wade Smith, MD, PhD; University of California, San Francisco

More Information

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT00932425
• Other Study ID Numbers: CMACS
• First Posted: July 3, 2009
• Results First Posted: February 27, 2015
• Last Update Posted: February 27, 2015
• Last Verified: February 2015

Keywords provided by University of California, San Francisco:

Stroke; Cryptogenic; Cardioembolic; Atrial Fibrillation

Additional relevant MeSH terms:

Stroke; Ischemic Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases