Genetic and Environmental Risk Factors for Hemorrhagic Stroke (GERFHS)
|Study Design:||Observational Model: Ecologic or Community
Time Perspective: Prospective
|Official Title:||Genetic and Environmental Risk Factors for Hemorrhagic Stroke|
- 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 ]
- 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
|Study Start Date:||September 1997|
|Study Completion Date:||June 2007|
|Primary Completion Date:||June 2007 (Final data collection date for primary outcome measure)|
Healthy volunteers and people who have had a hemorrhagic stroke and live within a 50 mile radius of Cincinnati, Ohio.
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:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00682695
|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|
|Principal Investigator:||Daniel Woo, MD||University of Cincinnati|