Siblings With Ischemic Stroke Study (SWISS)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00108940
First received: April 20, 2005
Last updated: September 23, 2011
Last verified: September 2011
  Purpose

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
Stroke

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Siblings With Ischemic Stroke Study

Further study details as provided by Mayo Clinic:

Biospecimen Retention:   Samples With DNA

Whole blood


Estimated Enrollment: 900
Study Start Date: December 2000
Study Completion Date: June 2011
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00108940

  Show 32 Study Locations
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: James F. Meschia, M.D. Mayo Clinic College of Medicine Jacksonville
  More Information

No publications provided

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
Study First Received: April 20, 2005
Last Updated: September 23, 2011
Health Authority: United States: Federal Government

Keywords provided by Mayo Clinic:
stroke
ischemic stroke
siblings

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

ClinicalTrials.gov processed this record on September 18, 2014