Trial Outcomes & Findings for Long-term Cardiac Monitoring After Cryptogenic Stroke (CMACS) (NCT NCT00932425)

NCT ID: NCT00932425

Last Updated: 2015-02-27

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2015-02-27

Participant Flow

40 patients were enrolled between October 29, 2009 and May 24, 2011

Participant milestones

Measure	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
Overall Study STARTED	20	20
Overall Study COMPLETED	20	18
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Measure	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
Overall Study Lost to Follow-up	0	1
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Long-term Cardiac Monitoring After Cryptogenic Stroke (CMACS)

Baseline characteristics by cohort

Measure	Outpatient Cardiac Monitoring n=20 Participants 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 n=20 Participants Patients discharged home with standard clinical follow-up	Total n=40 Participants Total of all reporting groups
Age, Continuous	65 years STANDARD_DEVIATION 15 • n=93 Participants	69 years STANDARD_DEVIATION 9 • n=4 Participants	67 years STANDARD_DEVIATION 12 • n=27 Participants
Sex: Female, Male Female	8 Participants n=93 Participants	9 Participants n=4 Participants	17 Participants n=27 Participants
Sex: Female, Male Male	12 Participants n=93 Participants	11 Participants n=4 Participants	23 Participants n=27 Participants
Region of Enrollment United States	20 participants n=93 Participants	20 participants n=4 Participants	40 participants n=27 Participants

PRIMARY outcome

Timeframe: 1 year

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

Outcome measures

Measure	Outpatient Cardiac Monitoring n=20 Participants 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 n=20 Participants Patients discharged home with standard clinical follow-up
Completion of Clinical Follow-up as a Measure of Feasibility	20 participants	18 participants

PRIMARY outcome

Timeframe: 21 days

Population: Only patients in the monitoring arm were assessed for compliance with assigned monitoring

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.

Outcome measures

Measure	Outpatient Cardiac Monitoring n=20 Participants 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
Completion of Assigned Monitoring as a Measure of Feasibility	15 participants	—

SECONDARY outcome

Timeframe: 90 days

Population: 2 patients in the control arm did not have a full 90 days of assessment (see Participant Flow)

Outcome measures

Measure	Outpatient Cardiac Monitoring n=20 Participants 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 n=18 Participants Patients discharged home with standard clinical follow-up
Diagnosis of Atrial Fibrillation	0 participants	0 participants

SECONDARY outcome

Timeframe: 1 year

Population: 2 participants in the Control arm were followed for less than 90 days

Outcome measures

Measure	Outpatient Cardiac Monitoring n=20 Participants 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 n=18 Participants Patients discharged home with standard clinical follow-up
Diagnosis of Atrial Fibrillation	0 participants	0 participants

SECONDARY outcome

Timeframe: 1 year

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.

Outcome measures

Measure	Outpatient Cardiac Monitoring n=20 Participants 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 n=18 Participants Patients discharged home with standard clinical follow-up
Recurrent Stroke or TIA Stroke	0 participants	1 participants
Recurrent Stroke or TIA TIA	1 participants	2 participants

Adverse Events

Outpatient Cardiac Monitoring

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Control

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Outpatient Cardiac Monitoring n=20 participants at risk 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 n=18 participants at risk Patients discharged home with standard clinical follow-up
Vascular disorders Stroke	0.00% 0/20 • 1 year 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	5.6% 1/18 • Number of events 1 • 1 year 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
Vascular disorders TIA	5.0% 1/20 • Number of events 1 • 1 year 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	11.1% 2/18 • Number of events 2 • 1 year 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

Other adverse events

Measure	Outpatient Cardiac Monitoring n=20 participants at risk 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 n=18 participants at risk Patients discharged home with standard clinical follow-up
Skin and subcutaneous tissue disorders Contact dermatitis	5.0% 1/20 • Number of events 1 • 1 year 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	— 0/0 • 1 year 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

Additional Information

Wade Smith, MD, PhD

University of California San Francisco

Phone: 415-353-8897

Email: smithw@neurology.ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place