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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Daniel Woo, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00930280
First received: June 29, 2009
Last updated: December 19, 2012
Last verified: December 2012
  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

Resource links provided by NLM:


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
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: NCT00930280

Locations
United States, Ohio
University of Cincinnati Department of Neurology
Cincinnati, Ohio, United States, 45267-0525
Sponsors and Collaborators
University of Cincinnati
Investigators
Principal Investigator: Daniel Woo, M.D. University of Cincinnati Department of Neurology
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 September 18, 2014