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Genetic and Environmental Risk Factors for Hemorrhagic Stroke (GERFHS)
This study has been completed.
Sponsors and Collaborators: University of Cincinnati
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT00682695
  Purpose

The purpose of this study is to find risk factors for hemorrhagic stroke.


Condition
Stroke

U.S. FDA Resources
Study Type: Observational
Study Design: Ecologic or Community, Prospective
Official Title: Genetic and Environmental Risk Factors for Hemorrhagic Stroke

Further study details as provided by National Institute of Neurological Disorders and Stroke (NINDS):

Primary Outcome Measures:
  • The analysis of the presence of specific genetic markers such as APOE4, APOE2 and Alpha-1-Antitrypsin gene mutations in people with hemorrhagic stroke versus the control group. [ Time Frame: Ongoing to be completed at the end of June 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Analysis of risk factors such as age, race, gender, current smoking, heavy alcohol use, use of anti-coagulants, 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 2008 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

whole blood or buccal DNA


Enrollment: 3187
Study Start Date: September 1997
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Healthy volunteers and people who have had a hemorrhagic stroke and live within a 50 mile radius of Cincinnati, Ohio.

Detailed Description:

Hemorrhagic stroke—specifically intracranial hemorrhage (ICH) and subarachnoid hemorrhage (SAH)—affects 50,000 to 60,000 individuals in the United States each year. The consequences of this type of stroke are devastating with 40 percent of cases ending in death within 30 days. Identifying the genetic and environmental risk factors for hemorrhagic stroke is beneficial and may lead to better treatments and possible preventions.

The purpose of this research study is to determine the significant environmental and genetic risk factors for intracerebral hemorrhage (bleeding in the brain tissue) and subarachnoid hemorrhage (bleeding around the brain). The researchers will look for the presence of several stroke-related genes and any environmental risk factors hat may contribute to stroke in people who have suffered a hemorrhagic stroke. Because environmental risk factors vary within different areas, this study will be limited to physician-reviewed cases of people who have had a hemorrhagic stroke and who live within a 50-mile radius of Cincinnati, Ohio.

There are two primary hypotheses in this study:

  1. The genetic and environmental factors associated with spontaneous ICH vary with the location and presumed mechanisms of a rupture in the artery. To test this theory researchers will divide the physician-reviewed cases of ICH into groups based on the location of the hemorrhage in the brain and determine which risk factors are associated with each group.
  2. The impact of environmental and genetic risk factors for spontaneous ICH and SAH in the population vary by gender and race. To analyze this hypothesis the researchers will divide the physician-reviewed cases of SAH and ICH into groups based on gender and race and look to see if polymorphisms (or naturally occurring variations in DNA sequence) of certain stroke-related genes are associated with a certain gender or race. The healthy volunteers and their genetic data will play an important role in this area as the researchers will compare healthy participants to those with hemorrhagic stroke. The investigators also will look for environmental risk factors (e.g., smoking, obesity, diabetes, etc.) that are prevalent in the participants with 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 and who live within a 50-mile radius of Cincinnati, Ohio.

Criteria

Inclusion Criteria:

  • Age 18 or older
  • Resident (6 months or longer) within 50 miles radius of the University of Cincinnati
  • Fulfillment of the criteria for spontaneous SAH or ICH
  • No evidence of trauma, brain tumor/metastases 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: NCT00682695

Locations
United States, Ohio
University of Cincinnati Academic Health Center, Department of Neurology, 260 Stetson St. Room # 2300, P.O. Box 670525
Cincinnati, Ohio, United States, 45267-0525
Sponsors and Collaborators
University of Cincinnati
Investigators
Principal Investigator: Joseph P. Broderick, MD University of Cincinnati
  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.
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;35:1703-1708.
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.
Sauerbeck LR, Khoury JC, Woo D, Kissela BM, Moomaw CJ, Broderick JP. Smoking cessation after stroke: education and its effect on behavior. J Neurosci Nurs. 2005 Dec;37(6):316-9, 325.
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 M, Flaherty M, Kissela B, Kleindorfer D, Schneider A, Khoury J, Sauerbeck L, Deka R, Broderick J. Genetic Epidemiology of Intracerebral Hemorrhage. Journal of Stroke and Cerebrovascular Diseases 2005;14:239-243.
Flaherty ML, Haverbusch M, Kissela B, Kleindorfer D, Schneider A, Sekar P, Moomaw CJ, Sauerbeck L, Broderick JP, Woo D. Perimesencephalic subarachnoid hemorrhage: incidence, risk factors, and outcome. J Stroke Cerebrovasc Dis. 2005 Nov-Dec;14(6):267-71.
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.
Woo D, Kaushal R, Kissela B, Sekar P, Wolujewicz M, Pal P, Alwell K, Haverbusch M, Ewing I, Miller R, Kleindorfer D, Flaherty M, Chakraborty R, Deka R, Broderick J. Association of Phosphodiesterase 4D with ischemic stroke: a population-based case-control study. Stroke. 2006 Feb;37(2):371-6. Epub 2005 Dec 22.
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.
Kaushal R, Pal P, Alwell K, Haverbusch M, Flaherty M, Moomaw C, Sekar P, Kissela B, Kleindorfer D, Chakraborty R, Broderick J, Deka R, Woo D. Association of ALOX5AP with ischemic stroke: a population-based case-control study. Hum Genet. 2007 Jun;121(5):601-7. Epub 2007 Mar 27.
Eden SV, Morgenstern LB, Sekar P, Moomaw CJ, Haverbusch M, Flaherty ML, Broderick JP, Woo D. The role of race in time to treatment after subarachnoid hemorrhage. Neurosurgery. 2007 May;60(5):837-43; discussion 837-43.
Kaushal R, Woo D, Pal P, Haverbusch M, Xi H, Moomaw C, Sekar P, Kissela B, Kleindorfer D, Flaherty M, Sauerbeck L, Chakraborty R, Broderick J, Deka R. Subarachnoid hemorrhage: tests of association with apolipoprotein E and elastin genes. BMC Med Genet. 2007 Jul 31;8:49.
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.
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.

Responsible Party: University of Cincinnati College of Medicine ( Joseph P. Broderick, MD, Chairman of the Department of Neurology )
Study ID Numbers: R01NS36695
Study First Received: May 20, 2008
Last Updated: May 20, 2008
ClinicalTrials.gov Identifier: NCT00682695  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Neurological Disorders and Stroke (NINDS):
stroke
brain attack
hemorrhagic stroke
risk factors

Study placed in the following topic categories:
Cerebral Infarction
Stroke
Vascular Diseases
Brain Ischemia
Central Nervous System Diseases
Ischemia
Brain Infarction
Intracranial Hemorrhages
Brain Diseases
Hemorrhage
Infarction
Cerebrovascular Disorders

Additional relevant MeSH terms:
Pathologic Processes
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009