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

July 1, 2009
October 15, 2013
September 2009
May 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00932425 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Long-term Cardiac Monitoring After Cryptogenic Stroke (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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Stroke
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)
  • Experimental: Outpatient cardiac monitoring
    Patients will be assigned to wear a portable outpatient cardiac telemetry device for 21 days
    Intervention: Device: Cardionet Mobile Cardiac Outpatient Telemetry (MCOT)
  • No Intervention: Control
    Patients will be discharged home with standard clinical follow-up
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
May 2011
May 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00932425
CMACS
No
University of California, San Francisco
University of California, San Francisco
Not Provided
Principal Investigator: Wade Smith, MD, PhD University of California, San Francisco
University of California, San Francisco
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP