Status:
COMPLETED
Occult Paroxysmal Atrial Fibrillation in Patients With Non-cardioembolic Ischemic Stroke of Determined Mechanism
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
LifeWatch Services, Inc.
Conditions:
Atrial Fibrillation
Stroke
Eligibility:
All Genders
50+ years
Brief Summary
The aim of this study is to determine the yield of 3 weeks outpatient mobile cardiac monitoring for detection of atrial fibrillation in patients with history of stroke of known cause.
Detailed Description
Patients will be recruited to wear a outpatient mobile cardiac monitoring device for detection of atrial fibrillation in patients with a history of stroke of known case. Their are not study treatments...
Eligibility Criteria
Inclusion
- Age \> 50
- Ischemic stroke, or transient ischemic attack with documented acute brain infarction, within prior 6 months.
- Patient does not merit indefinite oral anticoagulation. (Patients requiring temporary OAC for purposes other than recurrent stroke prevention, such as treatment of a deep venous thrombosis, are eligible for enrollment if the long-term secondary stroke preventive strategy is anti-platelet therapy and not OAC).
- Stroke mechanism is determined to be lacunar stroke, large vessel intracranial atherosclerosis, large vessel extracranial atherosclerosis, or a combination thereof.
- Patient has been evaluated with at least a 12 lead EKG and at least one day of in-patient or out-patient cardiac telemetry, with no detection of AF or atrial flutter.
- Detection of AF or atrial flutter would change secondary prevention antithrombotic strategy (eg to indefinite OAC).
- Patient receives and successfully activates LifeStar ACT device.
- Patient or legally authorized representative signs informed consent.
Exclusion
- Known history of AF or atrial flutter.
- Patient has defibrillator or pacemaker capable of detecting AF.
- Patient has indication for indefinite OAC.
- Patient has indefinite contra-indication to OAC. (Patients with temporary ineligibility for OAC, for example due to the need for invasive medical procedures or large acute brain infarction, are eligible for enrollment).
- Stroke due to known cause not listed in inclusion criterion 4.
- Cardioembolic stroke.
- Inability to comply with LifeStar ACT monitoring regimen.
Key Trial Info
Start Date :
April 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT01410396
Start Date
April 1 2010
End Date
May 1 2013
Last Update
August 15 2013
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60611