Long-term Cardiac Monitoring After Cryptogenic Stroke (CMACS)

Stroke Clinical Trial

— CMACS  

Official title:

Long-term Cardiac Monitoring After Cryptogenic Stroke (CMACS): A Pilot Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00932425
• Other study ID #: CMACS
• Status: Completed
• Phase: N/A
• First received: July 1, 2009
• Last updated: February 12, 2015
• Start date: September 2009
• Est. completion date: May 2011

Study information

• Verified date: February 2015
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Cardionet Mobile Cardiac Outpatient Telemetry (MCOT)
Patients will be assigned to wear the telemetry device for 21 days

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion of Clinical Follow-up as a Measure of Feasibility	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	1 year	No
Primary	Completion of Assigned Monitoring as a Measure of Feasibility	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.	21 days	No
Secondary	Diagnosis of Atrial Fibrillation		90 days	No
Secondary	Diagnosis of Atrial Fibrillation		1 year	No
Secondary	Recurrent Stroke or TIA	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.	1 year	Yes