Genetic and Environmental Risk Factors for Hemorrhagic Stroke-GERFHS III

NCT ID: NCT00930280

Last Updated: 2024-08-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 1260 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2025-06-30

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.

Conditions

Stroke

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

University of Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Daniel Woo

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Woo, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati Department of Neurology

Locations

University of Cincinnati Department of Neurology

Cincinnati, Ohio, United States

Countries

United States

References

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Reference Type: BACKGROUND

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Kissela BM, Sauerbeck L, Woo D, Khoury J, Carrozzella J, Pancioli A, Jauch E, Moomaw CJ, Shukla R, Gebel J, Fontaine R, Broderick J. Subarachnoid hemorrhage: a preventable disease with a heritable component. Stroke. 2002 May;33(5):1321-6. doi: 10.1161/01.str.0000014773.57733.3e.

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Woo D, Kissela BM, Khoury JC, Sauerbeck LR, Haverbusch MA, Szaflarski JP, Gebel JM, Pancioli AM, Jauch EC, Schneider A, Kleindorfer D, Broderick JP. Hypercholesterolemia, HMG-CoA reductase inhibitors, and risk of intracerebral hemorrhage: a case-control study. Stroke. 2004 Jun;35(6):1360-4. doi: 10.1161/01.STR.0000127786.16612.A4. Epub 2004 Apr 15.

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Flaherty ML, Woo D, Haverbusch M, Sekar P, Khoury J, Sauerbeck L, Moomaw CJ, Schneider A, Kissela B, Kleindorfer D, Broderick JP. Racial variations in location and risk of intracerebral hemorrhage. Stroke. 2005 May;36(5):934-7. doi: 10.1161/01.STR.0000160756.72109.95. Epub 2005 Mar 24.

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Flaherty ML, Tao H, Haverbusch M, Sekar P, Kleindorfer D, Kissela B, Khatri P, Stettler B, Adeoye O, Moomaw CJ, Broderick JP, Woo D. Warfarin use leads to larger intracerebral hematomas. Neurology. 2008 Sep 30;71(14):1084-9. doi: 10.1212/01.wnl.0000326895.58992.27.

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Stanton RJ, Eckman MH, Woo D, Moomaw CJ, Haverbusch M, Flaherty ML, Kleindorfer DO. Ischemic Stroke and Bleeding: Clinical Benefit of Anticoagulation in Atrial Fibrillation After Intracerebral Hemorrhage. Stroke. 2020 Mar;51(3):808-814. doi: 10.1161/STROKEAHA.119.027370. Epub 2020 Jan 31.

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Other Identifiers

5U01NS036695-16

Identifier Type: NIH

Identifier Source: secondary_id

View Link

36695-3

Identifier Type: -

Identifier Source: org_study_id