Genetic Studies to Identify Stroke Subtypes and Outcome
| Status: | Completed |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/21/2016 |
| Start Date: | June 2002 |
| End Date: | December 2008 |
Stroke Genomics - A Correlative Study of Stroke Subtypes, Neuroimaging, Therapy and Outcome Measures
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.
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.
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.
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.
- 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
We found this trial at
3
sites
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Suburban Hospital Suburban Hospital is a community-based, not-for-profit hospital serving Montgomery County and the surrounding...
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9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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