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

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ClinicalTrials.gov Identifier: NCT00930280
Recruitment Status : Active, not recruiting
First Posted : June 30, 2009
Last Update Posted : February 7, 2018
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Daniel Woo, 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.

Condition or disease
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 Type : Observational
Estimated Enrollment : 1260 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Genetic and Environmental Risk Factors for Hemorrhagic Stroke
Study Start Date : July 2008
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
whole blood


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00930280


Locations
United States, Ohio
University of Cincinnati Department of Neurology
Cincinnati, Ohio, United States, 45267-0525
Sponsors and Collaborators
University of Cincinnati
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Daniel Woo, M.D. University of Cincinnati Department of Neurology

Publications:
Woo D, Falcone GJ, Devan WJ, Brown WM, Biffi A, Howard TD, Anderson CD, Brouwers HB, Valant V, Battey TW, Radmanesh F, Raffeld MR, Baedorf-Kassis S, Deka R, Woo JG, Martin LJ, Haverbusch M, Moomaw CJ, Sun G, Broderick JP, Flaherty ML, Martini SR, Kleindorfer DO, Kissela B, Comeau ME, Jagiella JM, Schmidt H, Freudenberger P, Pichler A, Enzinger C, Hansen BM, Norrving B, Jimenez-Conde J, Giralt-Steinhauer E, Elosua R, Cuadrado-Godia E, Soriano C, Roquer J, Kraft P, Ayres AM, Schwab K, McCauley JL, Pera J, Urbanik A, Rost NS, Goldstein JN, Viswanathan A, Stögerer EM, Tirschwell DL, Selim M, Brown DL, Silliman SL, Worrall BB, Meschia JF, Kidwell CS, Montaner J, Fernandez-Cadenas I, Delgado P, Malik R, Dichgans M, Greenberg SM, Rothwell PM, Lindgren A, Slowik A, Schmidt R, Langefeld CD, Rosand J; International Stroke Genetics Consortium. Meta-analysis of genome-wide association studies identifies 1q22 as a susceptibility locus for intracerebral hemorrhage. Am J Hum Genet. 2014 Apr 3;94(4):511-21. doi: 10.1016/j.ajhg.2014.02.012. Epub 2014 Mar 20.

Responsible Party: Daniel Woo, Principal Investigator, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00930280     History of Changes
Other Study ID Numbers: 36695-3
5U01NS036695-16 ( U.S. NIH Grant/Contract )
First Posted: June 30, 2009    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Daniel Woo, University of Cincinnati:
stroke
brain attack
hemorrhagic stroke
risk factors

Additional relevant MeSH terms:
Stroke
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhage
Pathologic Processes