Genetic and Environmental Risk Factors for Hemorrhagic Stroke-GERFHS III (GERFHS-III)

August 27, 2024 updated by: Daniel Woo, University of Cincinnati

Genetic and Environmental Risk Factors for Hemorrhagic Stroke

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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

1260

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45267-0525
        • University of Cincinnati Department of Neurology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

This study will be limited to physician-reviewed cases of people who have had a hemorrhagic stroke, specifically an intracerebral hemorrhage, and live within a 100 mile radius of the University of Cincinnati.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The analysis of the presence of specific genetic markers associated with hemorrhagic stroke versus the control group.
Time Frame: 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.
Ongoing to be completed at the end of June 2013.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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.
Ongoing to be completed at the end of June 2013.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cincinnati

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

  • Principal Investigator: Daniel Woo, M.D., University of Cincinnati Department of Neurology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

June 29, 2009

First Submitted That Met QC Criteria

June 29, 2009

First Posted (Estimated)

June 30, 2009

Study Record Updates

Last Update Posted (Actual)

August 28, 2024

Last Update Submitted That Met QC Criteria

August 27, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36695-3
  • 5U01NS036695-16 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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