- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02734758
Markers of Atrial Fibrillation
Atrial Fibrillation in Ischemic Stroke: Strengthening Identification and Decisions to Anticoagulate
Study Overview
Status
Conditions
Detailed Description
Atrial fibrillation (AF) is a major cause of ischemic stroke that is critical to identify because anticoagulation provides a 66% risk reduction in recurrent stroke. However, opportunities to prevent stroke due to AF are frequently missed because AF is paroxysmal and therefore not detected at the time of stroke. In addition, even when AF is identified anticoagulation may not be initiated due to perceived contraindications.
This study will (1) evaluate whether a gene marker can improve the identification of AF in patients with ischemic stroke, and (2) evaluate decisions by health care provider and patients to anticoagulate AF, and whether this decision could be improved by a marker of AF at time of stroke. An AF Gene Score will be developed comprised of genes associated with inflammatory and thrombotic pathways related to risk of AF thromboembolism in stroke patients with AF. The AF Gene Score measured at time of stroke can stroke will permits rapid identification of stroke due to AF which may increase initiation of anticoagulation therapy. This is important in cryptogenic stroke, where prolonged monitoring leaves uncertainty regarding the association of delayed AF with initial stroke and delays anticoagulation.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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Sacramento, California, United States, 95817
- University of California Davis
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Ischemic stroke within 72 hours of onset
- Complete evaluation to determine cause of stroke
- Informed Consent
Exclusion Criteria:
- Active Infection
- Lymphoma / Leukemia / Blood dyscrasia
- Hemorrhagic stroke
- Immunosuppressive therapy
- Illicit drug use
- Blood transfusion +/- 1 month
- Major surgery/trauma in last 6mts
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Atrial fibrillation stroke
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Non-atrial fibrillation Stroke
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Gene expression
Time Frame: Post stroke through study completion, an average of 1 year
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Post stroke through study completion, an average of 1 year
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 248994
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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