Factor XI Levels in Acute Ischemic Stroke

August 2, 2011 updated by: University of Utah

The purpose of this study is to evaluate the utility of measuring coagulation factor activities in the setting of acute ischemic stroke, as potential markers of inherited thrombotic risk. The investigators will determine if relationships exist between coagulation factors, including factor VIII, factor IX, and factor XI and clinical diagnosis, classification, and outcome. The investigators will determine if any significant elevations of these factor activities are independent thrombotic risk factors.

Null Hypothesis: There is no statistical difference between coagulation factors, including factors VIII, IX, or XI activity levels in patients having acute ischemic stroke as compared to acute stroke mimics.

Study Overview

Status

Completed

Conditions

Detailed Description

Increased factor XI levels have been associated with venous thromboembolic disease and acute myocardial infarction. However, checking factor XI levels is not currently indicated to assess individual thromboembolic risk. Factor XI is an important protease that links the extrinsic arm of the coagulation cascade with the intrinsic arm through dual activation by both factor XII and thrombin. Since thrombin is a downstream product of factor XI, a feedback loop is created that amplifies thrombin production and ultimately results formation of a stable fibrin clot. Sufficient thrombin generation via this pathway also contributes to activation of the Thrombin-Activatable Fibrinolysis Inhibitor (TAFI). Activated TAFI downregulates fibrinolysis and has been implicated as part of the association between elevated factor XI levels and venous thromboembolic disease. One study found that functional TAFI levels of > 120% increased the risk of ischemic stroke approximately 6-fold, however, the association between Factor XI and ischemic stroke has yet to be firmly established. We recently performed a preliminary retrospective analysis of 78 patients with stroke or transient ischemic attack (TIA) and found that patients with factor XI activity levels above the 95th percentile of an age and sex matched reference population had a relative risk of 5.3 for stroke or TIA. Factor XI measurements may be able to help identify thromboembolic disease, aiding in the determination of stroke etiology.

Study Type

Observational

Enrollment (Actual)

450

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

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Health Sciences Center

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

Consecutive patients presenting to the University of Utah Health Sciences Center Emergency Department.

Description

Inclusion Criteria:

  • Those clinically diagnosed with acute ischemic stroke
  • 18 years of age or greater

Exclusion Criteria:

  • Those without clinical diagnosis of acute ischemic stroke will be included in the control group.
  • Patients with hemorrhagic strokes
  • Inpatients who are evaluated through the Brain Attack protocol

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
Factors VIII, IX and XI levels measured
Case group
Non Stroke patients
This is the control group. This group represents patients who were initially evaluated for stroke.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the relationship between elevated factors VIII, IX and XI and acute ischemic stroke as compared to other emergent events.
Time Frame: At time of incident stroke (baseline) and at early follow-up (30-60 Days post stroke).
At time of incident stroke (baseline) and at early follow-up (30-60 Days post stroke).

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the relationship between elevated factors VIII, IX and XI and stroke subtype.
Time Frame: 30-60 Days post stroke
30-60 Days post stroke
To determine if a relationship exists between elevated factors VIII, IX and XI and the clinical severity and stroke outcome.
Time Frame: 30-60 Days post stroke
30-60 Days post stroke
To determine if factors VIII, IX and XI level are different in the acute phase of ischemic stroke relative to chronic phase.
Time Frame: 30-60 Days post stroke
30-60 Days post stroke
To determine if a relationship exists between factors VIII, IX and XI levels and early stroke/TIA recurrence.
Time Frame: 30-60 Days post stroke
30-60 Days post stroke

Collaborators and Investigators

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

Sponsor

University of Utah

Collaborators

Sheila B. Terry Memorial Research Fund

Investigators

  • Principal Investigator: Jennifer Majersik, MD, University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2009

Primary Completion (ACTUAL)

July 1, 2011

Study Completion (ACTUAL)

July 1, 2011

Study Registration Dates

First Submitted

April 28, 2009

First Submitted That Met QC Criteria

April 29, 2009

First Posted (ESTIMATE)

April 30, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

August 4, 2011

Last Update Submitted That Met QC Criteria

August 2, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14363
  • ACC: 46499140
  • IRB: 00014363

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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