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Genetic and Environmental Risk Factors for Hemorrhagic Stroke-GERFHS III

Genetic and Environmental Risk Factors for Hemorrhagic Stroke

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00930280
Acronym
GERFHS-III
Enrollment
1260
Registered
2009-06-30
Start date
2008-07-31
Completion date
2025-06-30
Last updated
2024-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

stroke, brain attack, hemorrhagic stroke, risk factors

Brief summary

The purpose of this study is to find risk factors for hemorrhagic stroke, specifically intracerebral hemorrhage (ICH). ICH, a type of bleeding into brain tissue, is a type of stroke that can result in death or disability in a large number of people. Our study hopes to identify a specific genetic risk factor that will help identify at risk individuals and target treatment strategies.

Detailed description

Our case-control study will enroll subjects with a spontaneous ICH in the Greater Cincinnati region. For each subject enrolled we will also enroll a healthy control subject(matched by age , race and gender). Both the cases and control will undergo the same interview and have blood drawn for genetic analysis. The cases will have a chart abstraction done on their event medical record and be contacted for 3 and 6 month follow up(short interview). The genetic sample will be genotyped using the Affymetrix 6.0 gene chip looking for SNPs of interest and to identify genetic variants associated with ICH. The most promising SNPs identified through this process will be replicated in the external cohort from Massachusetts General Hospital.

Interventions

None listed

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)
CollaboratorNIH
University of Cincinnati
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Age 18 years or older * Resident (6 months or longer) within 100 miles of University of Cincinnati. * Fulfillment of the criteria for spontaneous ICH * No evidence of trauma, brain tumor/metastases, hemorrhagic transformation of ischemic stroke or infectious processes as a cause of the hemorrhage. * Ability of the patient or legal representative to provide consent for an interview, blood pressure determinations and DNA sampling.

Exclusion criteria

* N/A

Design outcomes

Primary

MeasureTime frameDescription
The analysis of the presence of specific genetic markers associated with hemorrhagic stroke versus the control group.Ongoing to be completed at the end of June 2013.Identification of specific genetic markers for each subject will be measured by gene assay using the Affymetrix chip. We are looking for SNPs that persist after controlling for traditional risk factors such as hypertension, smoking exposure, diabetes, alcohol use, anticoagulant use, hypercholesterolemia and APOE alleles.

Secondary

MeasureTime frameDescription
Analysis of risk factors such as age, race, gender, current smoking, heavy alcohol use, use of anticoagulants, diabetes, hemorrhagic stroke family history, hypertension, etc. in people with hemorrhagic stroke versus the control group.Ongoing to be completed at the end of June 2013.Traditional risk factors will be identified through self report during interview and by hospital chart notes for the case subjects. Identification of the APOE alleles for each subject will be done on their genetic sample.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026