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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

Tracking Information
First Submitted Date April 20, 2005
First Posted Date April 21, 2005
Last Update Posted Date September 27, 2011
Study Start Date December 2000
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00108940 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title Siblings With Ischemic Stroke Study
Official Title Siblings With Ischemic Stroke Study
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.

Study Type Observational
Study Design Observational Model: Family-Based
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood
Sampling Method Non-Probability Sample
Study Population in-patient or out-patient clinics, local community
Condition Stroke
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: June¬†23,¬†2005)
900
Original Enrollment Same as current
Actual Study Completion Date June 2011
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00108940
Other Study ID Numbers 1082-99
R01NS039987 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party James F. Meschia, MD, Mayo Clinic College of Medicine Jacksonville
Study Sponsor Mayo Clinic
Collaborators National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: James F. Meschia, M.D. Mayo Clinic
PRS Account Mayo Clinic
Verification Date September 2011