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Long-term Cardiac Monitoring After Cryptogenic Stroke (CMACS)

University of California San Francisco (UCSF) logo

University of California San Francisco (UCSF)

Status

Completed

Conditions

Stroke

Treatments

Device: Cardionet Mobile Cardiac Outpatient Telemetry (MCOT)

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Outpatient cardiac monitoring
Experimental group
Description:
Patients will be assigned to wear a portable outpatient cardiac telemetry device for 21 days
Treatment:
Device: Cardionet Mobile Cardiac Outpatient Telemetry (MCOT)
Control
No Intervention group
Description:
Patients will be discharged home with standard clinical follow-up

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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