Genetic Studies to Identify Stroke Subtypes and Outcome

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00357513
First received: July 26, 2006
Last updated: December 16, 2008
Last verified: December 2008
  Purpose

This study will characterize the gene response of the body's immune and inflammatory cells to stroke. There is a wide variation in stroke risk, stroke outcome, and response to clot-busting therapy for stroke. This variation may be due to differences in people's response to injury or infection, or to differences in genetic make-up between individuals. Genes store the biological information that determines the body's response to injury or infection. This study will analyze the activity of a large number of genes to try to learn which genes might be related to patient outcome. This, in turn, may lead to an understanding of which gene profiles are related to increased stroke risk and increased disability or death.

Healthy volunteers over age 21 and stroke patients over age 21 who are admitted to the NIH Stroke Program at Suburban Hospital in Bethesda, Md., may be eligible for this study. Volunteers will be screened with a medical history, blood pressure and pulse measurements, electrocardiogram, and neurological examination.

Participants will have 20 to 35 milliliters (about an ounce) of blood drawn for genetic studies. The genetic material will be extracted from the white blood cells and analyzed for normal and abnormal gene activity related to stroke.

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Condition
Cerebrovascular Disease
Stroke

Study Type: Observational
Official Title: Stroke Genomics - A Correlative Study of Stroke Subtypes, Neuroimaging, Therapy and Outcome Measures

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 840
Study Start Date: June 2002
Estimated Study Completion Date: December 2008
Detailed Description:

Background: In the United States, stroke is the third most common cause of death and the leading cause of adult disability. Despite the many efforts to find effective treatment for stroke there is at present only one acute stroke therapy. A major fact that has hindered stroke diagnosis and treatment is the lack of understanding about the pathophysiology of acute stroke. The advent of new brain imaging techniques has allowed the identification of further pathophysiological insights. To date, however, there has been a lack of genetic and molecular information, in part because the brain is not amenable to biopsy unlike other organs in the body. One new approach to studying the processes involved in the evolution of stroke and stroke recovery is the use of gene chip technology. The attraction of this technology is that it may allow differentiation of neurological conditions by non-invasive peripheral blood sampling. Objectives: The objective of this study will be to determine if the gene expression profile in white blood cells can be used to fingerprint different stroke subtypes and outcome. Study Design: Microarrays will be examined in a loop design allowing isolation of the gene effect from confounding variables by analysis of variance. Samples will be acquired from 200 control volunteers and 640 patients with various stroke subtypes. The stroke patients will have sequential samples taken at the time of stroke and during stroke recovery. Individual gene up-regulation and down-regulation will be defined by a univariate t-test comparison with the control population. These isolated gene effects will then be compared by the use of Hamming distances to define global statistical differences and graph analysis for inter-structure distances. Outcome Measures: Groups of genes with significantly altered expression in relation to stroke compared to controls allowing further examination of gene classes activity as potential stroke and stroke recovery fingerprints.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

HEALTHY VOLUNTEERS:

Over age 21

Healthy

Willing to participate in the study

Informed consent obtained

ACUTE STROKE PATIENTS:

Stroke patients admitted to Suburban or Holy Cross Hospitals

Over age 21

Willing to participate in the study

Informed Consent obtained

EXCLUSION CRITERIA:

HEALTHY VOLUNTEERS:

Active medical problems

Current symptomatic infection

Current severe allergic disorders

STROKE PATIENTS:

Cardiovascular instability

Severe anemia (hemoglobin less than 8.0 gm/dl)

Hemorrhagic diathesis

Current infection

Current severe allergic disorders

  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: NCT00357513

Locations
United States, Maryland
Suburban Hospital
Bethesda, Maryland, United States, 20814
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Holy Cross Hospital, Silver Spring
Silver Spring, Maryland, United States, 20902
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00357513     History of Changes
Other Study ID Numbers: 020221, 02-N-0221
Study First Received: July 26, 2006
Last Updated: December 16, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Cerebrovascular Disease
Gene Chip
Inflammation
Pathophysiology Stroke
Stroke Genomics
Stroke Subtypes
Neuroimaging
Clinical Outcome Measures
Stroke
CVA
Healthy Volunteer
HV
Normal Control

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 October 01, 2014