Long-term Cardiac Monitoring After Cryptogenic Stroke (CMACS)

NCT00932425 | Completed Results

• 1 other identifier: CMACS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Stroke; Cryptogenic; Cardioembolic; Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Diagnosis of Atrial Fibrillation

  90 days

• Diagnosis of Atrial Fibrillation

  1 year

• Recurrent Stroke or TIA

  1 year

Study Arms (2)

Outpatient cardiac monitoring

EXPERIMENTAL

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

Device: Cardionet Mobile Cardiac Outpatient Telemetry (MCOT)

Control

NO INTERVENTION

Patients will be discharged home with standard clinical follow-up

Interventions

Cardionet Mobile Cardiac Outpatient Telemetry (MCOT) DEVICE

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

Outpatient cardiac monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Stroke; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Wade Smith, MD, PhD
• Organization: University of California San Francisco

smithw@neurology.ucsf.edu

415-353-8897

Study Officials

• Wade Smith, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2009
• First Posted: July 3, 2009
• Study Start: September 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: February 27, 2015
• Results First Posted: February 27, 2015

Record last verified: 2015-02

Locations

US (1)