Markers of Atrial Fibrillation

Completed

• Conditions: Atrial Fibrillation; Stroke

• Registration Number: NCT02734758
• Lead Sponsor: University of California, Davis

Brief Summary

This study will evaluate whether a gene marker can improve the identification of atrial fibrillation in patients with ischemic stroke, and evaluate whether the decision to anticoagulate could be improved by a marker of atrial fibrillation.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2016-03-31
• Study First Submitted QC: 2016-04-05
• Study First Posted: 2016-04-12
• Primary Completion: 2016-08-01
• Study Completion: 2020-10-01
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-18
• Last Update Posted: 2020-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

Inclusion Criteria

• Ischemic stroke within 72 hours of onset
• Complete evaluation to determine cause of stroke
• Informed Consent

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gene expression	Post stroke through study completion, an average of 1 year

Trial Locations

Locations (1)

University of California Davis; 🇺🇸 Sacramento, California, United States