Markers of Atrial Fibrillation

November 18, 2020 updated by: University of California, Davis

Atrial Fibrillation in Ischemic Stroke: Strengthening Identification and Decisions to Anticoagulate

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.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

131

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Sacramento, California, United States, 95817
        • University of California Davis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with ischemic stroke

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Atrial fibrillation stroke
Non-atrial fibrillation Stroke

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
Post stroke through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2011

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

October 1, 2020

Study Registration Dates

First Submitted

March 31, 2016

First Submitted That Met QC Criteria

April 5, 2016

First Posted (Estimate)

April 12, 2016

Study Record Updates

Last Update Posted (Actual)

November 20, 2020

Last Update Submitted That Met QC Criteria

November 18, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

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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