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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00930280
Recruitment Status : Active, not recruiting
First Posted : June 30, 2009
Last Update Posted : September 26, 2019
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Daniel Woo, University of Cincinnati

Tracking Information
First Submitted Date June 29, 2009
First Posted Date June 30, 2009
Last Update Posted Date September 26, 2019
Study Start Date July 2008
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 5, 2018)
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.
Original Primary Outcome Measures
 (submitted: June 29, 2009)
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. ]
Change History Complete list of historical versions of study NCT00930280 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 5, 2018)
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.
Original Secondary Outcome Measures
 (submitted: June 29, 2009)
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. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Genetic and Environmental Risk Factors for Hemorrhagic Stroke-GERFHS III
Official Title Genetic and Environmental Risk Factors for Hemorrhagic Stroke
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.
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
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
whole blood
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.
Condition Stroke
Intervention Not Provided
Study 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: June 29, 2009)
1260
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00930280
Other Study ID Numbers 36695-3
5U01NS036695-16 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Daniel Woo, University of Cincinnati
Study Sponsor University of Cincinnati
Collaborators National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Daniel Woo, M.D. University of Cincinnati Department of Neurology
PRS Account University of Cincinnati
Verification Date September 2019