Clinical trial NCT00932425: Long-term Cardiac Monitoring After Cryptogenic Stroke (CMACS)
Official title: Long-term Cardiac Monitoring After Cryptogenic Stroke (CMACS): A Pilot Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Cryptogenic
Cardioembolic
Atrial Fibrillation
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2009-07-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Completion of Clinical Follow-up as a Measure of Feasibility
timeFrame: 1 year
measure: Completion of Assigned Monitoring as a Measure of Feasibility
timeFrame: 21 days
Secondary outcomes:
measure: Diagnosis of Atrial Fibrillation
timeFrame: 90 days
measure: Diagnosis of Atrial Fibrillation
timeFrame: 1 year
measure: Recurrent Stroke or TIA
timeFrame: 1 year
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Wade Smith, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: