Genetic and Environmental Risk Factors for Hemorrhagic Stroke-GERFHS III

Active, not recruiting

• Conditions: Stroke

• Registration Number: NCT00930280
• Lead Sponsor: University of Cincinnati

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.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2009-06-29
• Study First Submitted QC: 2009-06-29
• Study First Posted: 2009-06-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-27
• Last Update Posted: 2024-08-28
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1260

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Cincinnati Department of Neurology; 🇺🇸 Cincinnati, Ohio, United States