Genetic and Environmental Risk Factors for Hemorrhagic Stroke (GERFHS)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00682695
First received: May 20, 2008
Last updated: May 6, 2009
Last verified: May 2009
  Purpose

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


Condition
Stroke

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
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 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Daniel Woo, MD University of Cincinnati
  More Information

Publications:
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.
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.

Responsible Party: Daniel Woo, MD, University of Cincinnati College of Medicine
ClinicalTrials.gov Identifier: NCT00682695     History of Changes
Other Study ID Numbers: R01NS36695
Study First Received: May 20, 2008
Last Updated: May 6, 2009
Health Authority: United States: Federal Government

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 October 19, 2014