Siblings With Ischemic Stroke Study

NCT ID: NCT00108940

Last Updated: 2011-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

900 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-12-31

Study Completion Date

2011-06-30

Brief Summary

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The purpose of this study is to find the genes that increase the risk of developing an ischemic stroke using DNA samples collected from concordant (stroke-affected) sibling pairs.

Detailed Description

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Stroke is the third leading cause of death in the United States and a leading cause of acquired disability in adults. Each year, about 700,000 people experience stroke in the country. Ischemic stroke, which constitutes about 80 percent of all strokes, is a complex genetic disorder--the result of interactions between multiple genes and multiple environmental exposures. Genes affecting cholesterol, blood pressure, clotting, and other factors may increase the risk of ischemic stroke.

In this clinical study, investigators are studying groups of siblings in which at least two of the siblings have had an ischemic stroke. The goal of this multi-center study is to find the genes that increase the risk of developing an ischemic stroke.

To accomplish the aims of the study, researchers are using DNA samples collected from concordant (stroke-affected) sibling pairs to determine if there are regions in the human genome associated with ischemic stroke or that may harbor stroke susceptibility genes.

Two teaspoons of blood will be collected from each participant and submitted for genetic analysis. Understanding the genetic predisposition to stroke could have major benefits for public health.

Conditions

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Stroke

Study Design

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Observational Model Type

FAMILY_BASED

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Subject diagnosed by a study neurologist as having had a symptomatic ischemic stroke in the past.
* Head Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) done within 7 days of symptom onset confirms absence of etiology other than ischemic stroke.
* Subject reports having at least one living sibling with a stroke.
* Subject is 18 years of age or older.

Exclusion Criteria

* The index ischemic stroke occurred within 48 hours after a cardiovascular or cerebrovascular procedure.
* The index ischemic stroke occurred within 60 days after a non-traumatic subarachnoid hemorrhage.
* The subject has brain biopsy-proven central nervous system vasculitis.
* The subject is known to have any one of the following genetic disorders: CADASIL (Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy), Fabry's disease, homocystinuria, MELAS (Mitochondrial myopathy, Encephalopathy, Lactic Acidosis, Stroke), or sickle cell anemia.
* The subject has a mechanical aortic valve or mechanical mitral valve.
* The subject had untreated or actively treated bacterial endocarditis at the time of the index ischemic stroke.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Mayo Clinic College of Medicine Jacksonville

Principal Investigators

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James F. Meschia, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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University of South Alabama

Mobile, Alabama, United States

Site Status

Mayo Clinic Arizona

Scottsdale, Arizona, United States

Site Status

East Bay Region Assoc.

Berkeley, California, United States

Site Status

Scripps Clinic

La Jolla, California, United States

Site Status

University of California, Davis

Sacramento, California, United States

Site Status

Mercy General Hospital

Sacramento, California, United States

Site Status

Shands Jacksonville

Jacksonville, Florida, United States

Site Status

Mayo Clinic College of Medicine Jacksonville

Jacksonville, Florida, United States

Site Status

Florida Neurovascular Institute

Tampa, Florida, United States

Site Status

Cleveland Clinic - Florida

Weston, Florida, United States

Site Status

OSF St. Francis Medical Center

Peoria, Illinois, United States

Site Status

Indiana University/Clarian Health Partners

Indianapolis, Indiana, United States

Site Status

Mercy Medical Center

Sioux City, Iowa, United States

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University of Maryland

Baltimore, Maryland, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

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Washington University School of Medicine

St Louis, Missouri, United States

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Rochester General Hospital

Rochester, New York, United States

Site Status

Helen Hayes Hospital

West Haverstraw, New York, United States

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Wake Forest University School of Medicine

Winston-Salem, North Carolina, United States

Site Status

University of Cincinnati

Cincinnati, Ohio, United States

Site Status

Metro Health

Cleveland, Ohio, United States

Site Status

Ohio State University

Columbus, Ohio, United States

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University of Penn. Med. Center

Philadelphia, Pennsylvania, United States

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Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

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University of Virginia

Charlottesville, Virginia, United States

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St. Mary's Medical Center

Huntington, West Virginia, United States

Site Status

Luther Midelfort Clinic

Eau Claire, Wisconsin, United States

Site Status

University of Wisconsin, Madison

Madison, Wisconsin, United States

Site Status

Froedtert Memorial Lutheran

Milwaukee, Wisconsin, United States

Site Status

Hospital Charles Le Moyne

Greenfield Park, Quebec, Canada

Site Status

L'Enfant-Jesus Hospital

Québec, Quebec, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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R01NS039987

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1082-99

Identifier Type: -

Identifier Source: org_study_id