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Long-term Cardiac Monitoring After Cryptogenic Stroke (CMACS) (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: February 12, 2015
Last verified: February 2015
Results First Received: February 12, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Stroke
Intervention: Device: Cardionet Mobile Cardiac Outpatient Telemetry (MCOT)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
40 patients were enrolled between October 29, 2009 and May 24, 2011

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Outpatient Cardiac Monitoring

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

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

Control Patients discharged home with standard clinical follow-up

Participant Flow:   Overall Study
    Outpatient Cardiac Monitoring     Control  
STARTED     20     20  
COMPLETED     20     18  
NOT COMPLETED     0     2  
Lost to Follow-up                 0                 1  
Withdrawal by Subject                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
per protocol

Reporting Groups
  Description
Outpatient Cardiac Monitoring

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

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

Control Patients discharged home with standard clinical follow-up
Total Total of all reporting groups

Baseline Measures
    Outpatient Cardiac Monitoring     Control     Total  
Number of Participants  
[units: participants]
  20     20     40  
Age  
[units: years]
Mean (Standard Deviation)
  65  (15)     69  (9)     67  (12)  
Gender  
[units: participants]
     
Female     8     9     17  
Male     12     11     23  
Region of Enrollment  
[units: participants]
     
United States     20     20     40  



  Outcome Measures
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1.  Primary:   Completion of Clinical Follow-up as a Measure of Feasibility   [ Time Frame: 1 year ]

2.  Primary:   Completion of Assigned Monitoring as a Measure of Feasibility   [ Time Frame: 21 days ]

3.  Secondary:   Diagnosis of Atrial Fibrillation   [ Time Frame: 90 days ]

4.  Secondary:   Diagnosis of Atrial Fibrillation   [ Time Frame: 1 year ]

5.  Secondary:   Recurrent Stroke or TIA   [ Time Frame: 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Wade Smith, MD, PhD
Organization: University of California San Francisco
phone: 415-353-8897
e-mail: smithw@neurology.ucsf.edu



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
Results First Received: February 12, 2015
Last Updated: February 12, 2015
Health Authority: United States: Institutional Review Board