Clinical trial NCT00108940: Siblings With Ischemic Stroke Study
Official title: Siblings With Ischemic Stroke Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: stroke
ischemic stroke
siblings
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2005-04-21
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: in-patient or out-patient clinics, local community

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.

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.

Eligibility 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.

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