Genetic and Environmental Risk Factors for Hemorrhagic Stroke-GERFHS III - Full Text View

Purpose

The purpose of this study is to find risk factors for hemorrhagic stroke, specifically intracerebral hemorrhage (ICH).

Condition
Stroke

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	Genetic and Environmental Risk Factors for Hemorrhagic Stroke

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:

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. ] [ Designated as safety issue: No ]

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. [ Time Frame: Ongoing to be completed at the end of June 2013. ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

whole blood

Estimated Enrollment:	1260
Study Start Date:	July 2008
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts
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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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:

N/A

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

Publications:

Woo D, Sauerbeck LR, Kissela BM, Khoury JC, Szaflarski JP, Gebel J, Shukla R, Pancioli AM, Jauch EC, Menon AG, Deka R, Carrozzella JA, Moomaw CJ, Fontaine RN, Broderick JP. Genetic and environmental risk factors for intracerebral hemorrhage: preliminary results of a population-based study. Stroke. 2002 May;33(5):1190-5.

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.

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. Epub 2004 Apr 15.

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. Epub 2005 Mar 24.

Woo D, Kaushal R, Chakraborty R, Woo J, Haverbusch M, Sekar P, Kissela B, Pancioli A, Jauch E, Kleindorfer D, Flaherty M, Schneider A, Khatri P, Sauerbeck L, Khoury J, Deka R, Broderick J. Association of apolipoprotein E4 and haplotypes of the apolipoprotein E gene with lobar intracerebral hemorrhage. Stroke. 2005 Sep;36(9):1874-9. Epub 2005 Aug 11.

Woo D, Sekar P, Chakraborty R, Haverbusch MA, Flaherty ML, Kissela BM, Kleindorfer D, Schneider A, Khoury J, Sauerbeck LR, Deka R, Broderick JP. Genetic epidemiology of intracerebral hemorrhage. J Stroke Cerebrovasc Dis. 2005 Nov-Dec;14(6):239-43.

Flaherty ML, Woo D, Haverbusch M, Moomaw CJ, Sekar P, Sauerbeck L, Kissela B, Kleindorfer D, Broderick JP. Potential applicability of recombinant factor VIIa for intracerebral hemorrhage. Stroke. 2005 Dec;36(12):2660-4. Epub 2005 Nov 3.

Flaherty ML, Haverbusch M, Sekar P, Kissela B, Kleindorfer D, Moomaw CJ, Sauerbeck L, Schneider A, Broderick JP, Woo D. Long-term mortality after intracerebral hemorrhage. Neurology. 2006 Apr 25;66(8):1182-6.

Flaherty ML, Haverbusch M, Sekar P, Kissela BM, Kleindorfer D, Moomaw CJ, Broderick JP, Woo D. Location and outcome of anticoagulant-associated intracerebral hemorrhage. Neurocrit Care. 2006;5(3):197-201.

Flaherty ML, Kissela B, Woo D, Kleindorfer D, Alwell K, Sekar P, Moomaw CJ, Haverbusch M, Broderick JP. The increasing incidence of anticoagulant-associated intracerebral hemorrhage. Neurology. 2007 Jan 9;68(2):116-21.

Woo D, Broderick JP. Spontaneous intracerebral hemorrhage: epidemiology and clinical presentation. Neurosurg Clin N Am. 2002 Jul;13(3):265-79, v. Review.

Flaherty ML, Adeoye O, Sekar P, Haverbusch M, Moomaw CJ, Tao H, Broderick JP, Woo D. The challenge of designing a treatment trial for warfarin-associated intracerebral hemorrhage. Stroke. 2009 May;40(5):1738-42. Epub 2009 Mar 12.

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.

Adeoye O, Woo D, Haverbusch M, Tao H, Sekar P, Moomaw CJ, Shutter L, Kleindorfer D, Kissela B, Broderick J, Flaherty ML. Eligibility for the surgical trial in intracerebral hemorrhage II study in a population-based cohort. Neurocrit Care. 2008;9(2):237-41.

Flaherty ML, Woo D, Broderick J. The incidence of deep and lobar intracerebral hemorrhage in whites, blacks, and Hispanics. Neurology. 2006 Mar 28;66(6):956-7; author reply 956-7. No abstract available.

Adeoye O, Woo D, Haverbusch M, Sekar P, Moomaw CJ, Broderick J, Flaherty ML. Surgical management and case-fatality rates of intracerebral hemorrhage in 1988 and 2005. Neurosurgery. 2008 Dec;63(6):1113-7; discussion 1117-8.

Woo D, Haverbusch M, Sekar P, Kissela B, Khoury J, Schneider A, Kleindorfer D, Szaflarski J, Pancioli A, Jauch E, Moomaw C, Sauerbeck L, Gebel J, Broderick J. Effect of untreated hypertension on hemorrhagic stroke. Stroke. 2004 Jul;35(7):1703-8. Epub 2004 May 20.

Kharofa J, Sekar P, Haverbusch M, Moomaw C, Flaherty M, Kissela B, Broderick J, Woo D. Selective serotonin reuptake inhibitors and risk of hemorrhagic stroke. Stroke. 2007 Nov;38(11):3049-51. Epub 2007 Sep 27.

Adeoye O, Haverbusch M, Woo D, Sekar P, Moomaw CJ, Kleindorfer D, Stettler B, Kissela BM, Broderick JP, Flaherty ML. Is ED disposition associated with intracerebral hemorrhage mortality? Am J Emerg Med. 2011 May;29(4):391-5. doi: 10.1016/j.ajem.2009.10.016. Epub 2010 Mar 25.

Martini SR, Flaherty ML, Brown WM, Haverbusch M, Comeau ME, Sauerbeck LR, Kissela BM, Deka R, Kleindorfer DO, Moomaw CJ, Broderick JP, Langefeld CD, Woo D. Risk factors for intracerebral hemorrhage differ according to hemorrhage location. Neurology. 2012 Dec 4;79(23):2275-82. doi: 10.1212/WNL.0b013e318276896f. Epub 2012 Nov 21.

Responsible Party:	Daniel Woo, Principal Investigator, University of Cincinnati
ClinicalTrials.gov Identifier:	NCT00930280 History of Changes
Other Study ID Numbers:	36695-3, NS036695-10A2
Study First Received:	June 29, 2009
Last Updated:	December 19, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Cincinnati:

stroke
brain attack
hemorrhagic stroke
risk factors

Additional relevant MeSH terms:

Stroke
Cerebral Infarction
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013

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