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Genetic Studies to Identify Stroke Subtypes and Outcome

Primary Purpose

Cerebrovascular Disease, Stroke

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institute of Neurological Disorders and Stroke (NINDS)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cerebrovascular Disease focused on measuring Cerebrovascular Disease, Gene Chip, Inflammation, Pathophysiology Stroke, Stroke Genomics, Stroke Subtypes, Neuroimaging, Clinical Outcome Measures, Stroke, CVA, Healthy Volunteer, HV, Normal Control

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Suburban Hospital
  • National Institutes of Health Clinical Center, 9000 Rockville Pike
  • Holy Cross Hospital, Silver Spring

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 26, 2006
Last Updated
June 30, 2017
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00357513
Brief Title
Genetic Studies to Identify Stroke Subtypes and Outcome
Official Title
Stroke Genomics - A Correlative Study of Stroke Subtypes, Neuroimaging, Therapy and Outcome Measures
Study Type
Observational

2. Study Status

Record Verification Date
December 15, 2008
Overall Recruitment Status
Completed
Study Start Date
June 3, 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 15, 2008 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

5. Study Description

Brief Summary
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. ...
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Disease, Stroke
Keywords
Cerebrovascular Disease, Gene Chip, Inflammation, Pathophysiology Stroke, Stroke Genomics, Stroke Subtypes, Neuroimaging, Clinical Outcome Measures, Stroke, CVA, Healthy Volunteer, HV, Normal Control

7. Study Design

Enrollment
840 (false)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Suburban Hospital
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Facility Name
Holy Cross Hospital, Silver Spring
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11318610
Citation
Acierno JS Jr, Kennedy JC, Falardeau JL, Leyne M, Bromley MC, Colman MW, Sun M, Bove C, Ashworth LK, Chadwick LH, Schiripo T, Ma S, Goldin E, Schiffmann R, Slaugenhaupt SA. A physical and transcript map of the MCOLN1 gene region on human chromosome 19p13.3-p13.2. Genomics. 2001 Apr 15;73(2):203-10. doi: 10.1006/geno.2001.6526.
Results Reference
background
PubMed Identifier
9153519
Citation
Baird AE, Benfield A, Schlaug G, Siewert B, Lovblad KO, Edelman RR, Warach S. Enlargement of human cerebral ischemic lesion volumes measured by diffusion-weighted magnetic resonance imaging. Ann Neurol. 1997 May;41(5):581-9. doi: 10.1002/ana.410410506.
Results Reference
background
PubMed Identifier
9626183
Citation
Baird AE, Warach S. Magnetic resonance imaging of acute stroke. J Cereb Blood Flow Metab. 1998 Jun;18(6):583-609. doi: 10.1097/00004647-199806000-00001. Erratum In: J Cereb Blood Flow Metab 1998 Oct;18(10):preceding 1047.
Results Reference
background

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Genetic Studies to Identify Stroke Subtypes and Outcome

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