Siblings With Ischemic Stroke Study

Stroke Clinical Trial

— SWISS  

Official title:

Siblings With Ischemic Stroke Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00108940
• Other study ID #: 1082-99
• Secondary ID: R01NS039987
• Status: Completed
• Phase: N/A
• First received: April 20, 2005
• Last updated: September 23, 2011
• Start date: December 2000
• Est. completion date: June 2011

Study information

• Verified date: September 2011
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: June 2011
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Family-Based, Time Perspective: Prospective

Related Conditions & MeSH terms

• Stroke

Locations

Country	Name	City	State
Canada	Hospital Charles Le Moyne	Greenfield Park	Quebec
Canada	L'Enfant-Jesus Hospital	Quebec City	Quebec
United States	University of Maryland	Baltimore	Maryland
United States	East Bay Region Assoc.	Berkeley	California
United States	University of Virginia	Charlottesville	Virginia
United States	University of Cincinnati	Cincinnati	Ohio
United States	Metro Health	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	Luther Midelfort Clinic	Eau Claire	Wisconsin
United States	St. Mary's Medical Center	Huntington	West Virginia
United States	Indiana University/Clarian Health Partners	Indianapolis	Indiana
United States	Mayo Clinic College of Medicine Jacksonville	Jacksonville	Florida
United States	Shands Jacksonville	Jacksonville	Florida
United States	Scripps Clinic	La Jolla	California
United States	University of Wisconsin, Madison	Madison	Wisconsin
United States	Froedtert Memorial Lutheran	Milwaukee	Wisconsin
United States	University of South Alabama	Mobile	Alabama
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	OSF St. Francis Medical Center	Peoria	Illinois
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	University of Penn. Med. Center	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	Rochester General Hospital	Rochester	New York
United States	Mercy General Hospital	Sacramento	California
United States	University of California, Davis	Sacramento	California
United States	Mayo Clinic Arizona	Scottsdale	Arizona
United States	Mercy Medical Center	Sioux City	Iowa
United States	Washington University School of Medicine	St. Louis	Missouri
United States	Florida Neurovascular Institute	Tampa	Florida
United States	Helen Hayes Hospital	West Haverstraw	New York
United States	Cleveland Clinic - Florida	Weston	Florida
United States	Wake Forest University School of Medicine	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Institute of Neurological Disorders and Stroke (NINDS)

Countries where clinical trial is conducted

United States,  Canada,