Factor XI Levels in Acute Ischemic Stroke

This study has been completed.
Sponsor:
Collaborator:
Sheila B. Terry Memorial Research Fund
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT00890812
First received: April 28, 2009
Last updated: August 2, 2011
Last verified: August 2011
  Purpose

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.


Condition
Stroke

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Factor XI Levels in Acute Ischemic Stroke

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the relationship between elevated factors VIII, IX and XI and stroke subtype. [ Time Frame: 30-60 Days post stroke ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

A small 2ml vial of spun plasma


Enrollment: 450
Study Start Date: May 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00890812

Locations
United States, Utah
University of Utah Health Sciences Center
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Sheila B. Terry Memorial Research Fund
Investigators
Principal Investigator: Jennifer Majersik, MD University of Utah
  More Information

Publications:

Responsible Party: Jennifer Majersik, MD, University of Utah
ClinicalTrials.gov Identifier: NCT00890812     History of Changes
Other Study ID Numbers: 14363, ACC: 46499140, IRB: 00014363
Study First Received: April 28, 2009
Last Updated: August 2, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
Acute Ischemic Stroke

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 11, 2014