We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00932425
Recruitment Status : Completed
First Posted : July 3, 2009
Results First Posted : February 27, 2015
Last Update Posted : February 27, 2015
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Stroke
Intervention Device: Cardionet Mobile Cardiac Outpatient Telemetry (MCOT)
Enrollment 40
Recruitment Details 40 patients were enrolled between October 29, 2009 and May 24, 2011
Pre-assignment Details  
Arm/Group Title Outpatient Cardiac Monitoring Control
Hide Arm/Group Description

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

 Patients discharged home with standard clinical follow-up
Period Title: Overall Study
Started 20 20
Completed 20 18
Not Completed 0 2
Reason Not Completed
Lost to Follow-up             0             1
Withdrawal by Subject             0             1
Arm/Group Title Outpatient Cardiac Monitoring Control Total
Hide Arm/Group Description

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

 Patients discharged home with standard clinical follow-up Total of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
per protocol
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
65  (15) 69  (9) 67  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
8
  40.0%
9
  45.0%
17
  42.5%
Male
12
  60.0%
11
  55.0%
23
  57.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 20 participants 40 participants
20 20 40
1.Primary Outcome
Title Completion of Clinical Follow-up as a Measure of Feasibility
Hide Description 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
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Outpatient Cardiac Monitoring Control
Hide Arm/Group Description:

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
Patients discharged home with standard clinical follow-up
Overall Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: participants
20 18
2.Primary Outcome
Title Completion of Assigned Monitoring as a Measure of Feasibility
Hide Description 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.
Time Frame 21 days
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients in the monitoring arm were assessed for compliance with assigned monitoring
Arm/Group Title Outpatient Cardiac Monitoring
Hide Arm/Group Description:

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
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
15
3.Secondary Outcome
Title Diagnosis of Atrial Fibrillation
Hide Description [Not Specified]
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
2 patients in the control arm did not have a full 90 days of assessment (see Participant Flow)
Arm/Group Title Outpatient Cardiac Monitoring Control
Hide Arm/Group Description:

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
Patients discharged home with standard clinical follow-up
Overall Number of Participants Analyzed 20 18
Measure Type: Number
Unit of Measure: participants
0 0
4.Secondary Outcome
Title Diagnosis of Atrial Fibrillation
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
2 participants in the Control arm were followed for less than 90 days
Arm/Group Title Outpatient Cardiac Monitoring Control
Hide Arm/Group Description:

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
Patients discharged home with standard clinical follow-up
Overall Number of Participants Analyzed 20 18
Measure Type: Number
Unit of Measure: participants
0 0
5.Secondary Outcome
Title Recurrent Stroke or TIA
Hide Description 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.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Outpatient Cardiac Monitoring Control
Hide Arm/Group Description:

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
Patients discharged home with standard clinical follow-up
Overall Number of Participants Analyzed 20 18
Measure Type: Number
Unit of Measure: participants
Stroke 0 1
TIA 1 2
Time Frame 1 year
Adverse Event Reporting Description Participants were assessed for adverse events attributable to the intervention during the monitoring period, and for recurrent stroke or TIA at 3 months and 1 year
 
Arm/Group Title Outpatient Cardiac Monitoring Control
Hide Arm/Group Description

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

 Patients discharged home with standard clinical follow-up
All-Cause Mortality
Outpatient Cardiac Monitoring Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Outpatient Cardiac Monitoring Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/20 (5.00%)      3/18 (16.67%)    
Vascular disorders     
Stroke †  0/20 (0.00%)  0 1/18 (5.56%)  1
TIA †  1/20 (5.00%)  1 2/18 (11.11%)  2
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Outpatient Cardiac Monitoring Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/20 (5.00%)      0/0    
Skin and subcutaneous tissue disorders     
Contact dermatitis † [1]  1/20 (5.00%)  1 0/0  0
†
Indicates events were collected by systematic assessment
[1]
One participant in the monitoring group had contact dermatitis, which we classified as an AE attributable to the intervention.
[Not Specified]
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
Layout table for Results Point of Contact information
Name/Title: Wade Smith, MD, PhD
Organization: University of California San Francisco
Phone: 415-353-8897
EMail: smithw@neurology.ucsf.edu
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00932425    
Other Study ID Numbers: CMACS
First Submitted: July 1, 2009
First Posted: July 3, 2009
Results First Submitted: February 12, 2015
Results First Posted: February 27, 2015
Last Update Posted: February 27, 2015