GERFHS-III: Genetic and Environmental Risk Factors for Hemorrhagic Stroke-GERFHS III

Sponsor

University of Cincinnati (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT00930280

Collaborator

National Institute of Neurological Disorders and Stroke (NINDS) (NIH)

1,260

Enrollment

Location

167

Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1260 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Genetic and Environmental Risk Factors for Hemorrhagic Stroke

Study Start Date :

Jul 1, 2008

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Hemorrhagic stroke cases People who have had a hemorrhagic stroke, specifically an intracerebral hemorrhage, and live within a 100 mile radius of the University of Cincinnati.
Healthy Control Subjects Healthy volunteers who are randomly identified in the same 100 mile radius of the University of Cincinnati and have not had a hemorrhagic stroke.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.