NCT02734758

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 12, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

November 20, 2020

Status Verified

November 1, 2020

Enrollment Period

5 years

First QC Date

March 31, 2016

Last Update Submit

November 18, 2020

Conditions

StrokeAtrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Gene expression

    Post stroke through study completion, an average of 1 year

Study Arms (2)

Atrial fibrillation stroke

Non-atrial fibrillation Stroke

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with ischemic stroke

You may qualify if:

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

You may not qualify if:

  • Active Infection
  • Lymphoma / Leukemia / Blood dyscrasia
  • Hemorrhagic stroke
  • Immunosuppressive therapy
  • Illicit drug use
  • Blood transfusion +/- 1 month
  • Major surgery/trauma in last 6mts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Davis

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

StrokeAtrial Fibrillation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesArrhythmias, CardiacHeart DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2016

First Posted

April 12, 2016

Study Start

August 1, 2011

Primary Completion

August 1, 2016

Study Completion

October 1, 2020

Last Updated

November 20, 2020

Record last verified: 2020-11

Locations

US(1)