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Siblings With Ischemic Stroke Study (SWISS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00108940
Recruitment Status : Completed
First Posted : April 21, 2005
Last Update Posted : September 27, 2011
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:
Mayo Clinic

Brief Summary:
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.

Condition or disease
Stroke

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 900 participants
Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Siblings With Ischemic Stroke Study
Study Start Date : December 2000
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2011



Biospecimen Retention:   Samples With DNA
Whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
in-patient or out-patient clinics, local community
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00108940


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Locations
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United States, Alabama
University of South Alabama
Mobile, Alabama, United States, 36617
United States, Arizona
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85054
United States, California
East Bay Region Assoc.
Berkeley, California, United States, 94705
Scripps Clinic
La Jolla, California, United States, 92039
University of California, Davis
Sacramento, California, United States, 95817
Mercy General Hospital
Sacramento, California, United States, 95819
United States, Florida
Shands Jacksonville
Jacksonville, Florida, United States, 32209
Mayo Clinic College of Medicine Jacksonville
Jacksonville, Florida, United States, 32224
Florida Neurovascular Institute
Tampa, Florida, United States, 33606
Cleveland Clinic - Florida
Weston, Florida, United States, 33331
United States, Illinois
OSF St. Francis Medical Center
Peoria, Illinois, United States, 61637
United States, Indiana
Indiana University/Clarian Health Partners
Indianapolis, Indiana, United States, 46202
United States, Iowa
Mercy Medical Center
Sioux City, Iowa, United States, 51101
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New York
Rochester General Hospital
Rochester, New York, United States
Helen Hayes Hospital
West Haverstraw, New York, United States, 10994
United States, North Carolina
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267-0525
Metro Health
Cleveland, Ohio, United States, 44109
Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
University of Penn. Med. Center
Philadelphia, Pennsylvania, United States, 19104
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
United States, West Virginia
St. Mary's Medical Center
Huntington, West Virginia, United States, 25702
United States, Wisconsin
Luther Midelfort Clinic
Eau Claire, Wisconsin, United States, 54703
University of Wisconsin, Madison
Madison, Wisconsin, United States, 53792
Froedtert Memorial Lutheran
Milwaukee, Wisconsin, United States, 53226
Canada, Quebec
Hospital Charles Le Moyne
Greenfield Park, Quebec, Canada, J4V2H1
L'Enfant-Jesus Hospital
Quebec City, Quebec, Canada
Sponsors and Collaborators
Mayo Clinic
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: James F. Meschia, M.D. Mayo Clinic

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Responsible Party: James F. Meschia, MD, Mayo Clinic College of Medicine Jacksonville
ClinicalTrials.gov Identifier: NCT00108940     History of Changes
Other Study ID Numbers: 1082-99
R01NS039987 ( U.S. NIH Grant/Contract )
First Posted: April 21, 2005    Key Record Dates
Last Update Posted: September 27, 2011
Last Verified: September 2011

Keywords provided by Mayo Clinic:
stroke
ischemic stroke
siblings

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