Genetic Studies to Identify Stroke Subtypes and Outcome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

840 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-06-03

Study Completion Date

2008-12-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

...

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Genetic Variants in Stroke

NCT07186517

Stroke Genetic Association Studies

NOT_YET_RECRUITING

Genetic and Blood Biomarkers in Neurological and Neuromuscular Diseases

NCT02780531

Neurological Disorders Neuromuscular Disorders

COMPLETED

Genetic Identification of Monogenic Disorders in Early-onset Stroke Using Targeted Next Generation Sequencing Panel

NCT04485598

Stroke, Acute Transient Ischemic Attack Single-gene Disorders

COMPLETED

Familial Intracranial Aneurysm Study II

NCT00071565

Intracranial Aneurysm Subarachnoid Hemorrhage

COMPLETED

Genetic Analysis of Familial Brain Aneurysms

NCT00011856

Intracranial Aneurysm

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cerebrovascular Disease Stroke

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes