Occult Paroxysmal Atrial Fibrillation in Patients With Non-cardioembolic Ischemic Stroke of Determined Mechanism
This study is currently recruiting participants.
Verified August 2011 by Northwestern University
Sponsor:
Northwestern University
Collaborator:
Lifewatch Corp
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT01410396
First received: August 3, 2011
Last updated: August 4, 2011
Last verified: August 2011
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Purpose
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.
| Condition |
|---|
|
Atrial Fibrillation Stroke |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial atrial fibrillation
MedlinePlus related topics:
Atrial Fibrillation
U.S. FDA Resources
Further study details as provided by Northwestern University:
Primary Outcome Measures:
- Detection of any episode of AF >30 seconds during 21 days of mobile outpatient cardiac telemetry [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Recurrent ischemic stroke [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 100 |
| Study Start Date: | April 2010 |
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients with history of stroke of known mechanism age greater than 50
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01410396
Locations
| United States, Illinois | |
| Northwestern University | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Kathryn L Muskovich 312-503-0492 k-muskovich@northwestern.edu | |
| Principal Investigator: Richard A Bernstein, MD, PhD | |
Sponsors and Collaborators
Northwestern University
Lifewatch Corp
More Information
No publications provided
| Responsible Party: | Richard Bernstein, MD, PhD, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT01410396 History of Changes |
| Other Study ID Numbers: | Lifewatch |
| Study First Received: | August 3, 2011 |
| Last Updated: | August 4, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Northwestern University:
|
Atrial Fibrillation Stroke |
Additional relevant MeSH terms:
|
Atrial Fibrillation Stroke Cerebral Infarction Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |
Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on May 19, 2013