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

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Cardionet Mobile Cardiac Outpatient Telemetry (MCOT)

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis of Atrial Fibrillation		90 days
Diagnosis of Atrial Fibrillation		1 year
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

Collaborators and Investigators

• Sponsor: University of California, San Francisco

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: July 1, 2009
• First Submitted That Met QC Criteria: July 2, 2009
• First Posted (Estimate): July 3, 2009

Study Record Updates

• Last Update Posted (Estimate): February 27, 2015
• Last Update Submitted That Met QC Criteria: February 12, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Stroke; Atrial Fibrillation; Cryptogenic; Cardioembolic
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: CMACS