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Long-term Cardiac Monitoring After Cryptogenic Stroke (CMACS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00932425
First received: July 1, 2009
Last updated: October 15, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Stroke
Device: Cardionet Mobile Cardiac Outpatient Telemetry (MCOT)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Long-term Cardiac Monitoring After Cryptogenic Stroke (CMACS): A Pilot Randomized Trial

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Feasibility, defined as more than 80% of randomized patients completing full clinical follow-up and more than 70% of cardiac monitoring if applicable [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Diagnosis of atrial fibrillation [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Diagnosis of atrial fibrillation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Recurrent stroke [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: September 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Cardionet Mobile Cardiac Outpatient Telemetry (MCOT)
No Intervention: Control
Patients will be discharged home with standard clinical follow-up

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00932425

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

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00932425     History of Changes
Other Study ID Numbers: CMACS
Study First Received: July 1, 2009
Last Updated: October 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Stroke
Cryptogenic
Cardioembolic
Atrial Fibrillation

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014