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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cardionet Mobile Cardiac Outpatient Telemetry (MCOT)
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stroke focused on measuring Stroke, Cryptogenic, Cardioembolic, Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Outpatient cardiac monitoring

Control

Arm Description

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

Patients will be discharged home with standard clinical follow-up

Outcomes

Primary Outcome Measures

Completion of Clinical Follow-up as a Measure of Feasibility
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
Completion of Assigned Monitoring as a Measure of Feasibility
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.

Secondary Outcome Measures

Diagnosis of Atrial Fibrillation
Diagnosis of Atrial Fibrillation
Recurrent Stroke or TIA
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.

Full Information

First Posted
July 1, 2009
Last Updated
February 12, 2015
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT00932425
Brief Title
Long-term Cardiac Monitoring After Cryptogenic Stroke (CMACS)
Acronym
CMACS
Official Title
Long-term Cardiac Monitoring After Cryptogenic Stroke (CMACS): A Pilot Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Cryptogenic, Cardioembolic, Atrial Fibrillation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Outpatient cardiac monitoring
Arm Type
Experimental
Arm Description
Patients will be assigned to wear a portable outpatient cardiac telemetry device for 21 days
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients will be discharged home with standard clinical follow-up
Intervention Type
Device
Intervention Name(s)
Cardionet Mobile Cardiac Outpatient Telemetry (MCOT)
Intervention Description
Patients will be assigned to wear the telemetry device for 21 days
Primary Outcome Measure Information:
Title
Completion of Clinical Follow-up as a Measure of Feasibility
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
Title
Completion of Assigned Monitoring as a Measure of Feasibility
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
Secondary Outcome Measure Information:
Title
Diagnosis of Atrial Fibrillation
Time Frame
90 days
Title
Diagnosis of Atrial Fibrillation
Time Frame
1 year
Title
Recurrent Stroke or TIA
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wade Smith, MD, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

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Long-term Cardiac Monitoring After Cryptogenic Stroke (CMACS)

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