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Ethnic/Racial Variations of Intracerebral Hemorrhage (ERICH) (ERICH)

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ClinicalTrials.gov Identifier: NCT01202864
Recruitment Status : Completed
First Posted : September 16, 2010
Last Update Posted : September 1, 2017
Sponsor:
Collaborators:
Massachusetts General Hospital
Columbia University
University of Maryland
Georgetown University
Wake Forest University
Emory University
University of Miami
University of Illinois at Chicago
University of Texas, Southwestern Medical Center at Dallas
The University of Texas Health Science Center, Houston
The University of Texas Health Science Center at San Antonio
University of New Mexico
University of Arizona
University of Southern California
St. Luke's-Roosevelt Hospital Center
University of California, San Francisco
Duke University
University of Virginia
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Daniel Woo, University of Cincinnati

Tracking Information
First Submitted Date September 14, 2010
First Posted Date September 16, 2010
Last Update Posted Date September 1, 2017
Actual Study Start Date August 1, 2010
Actual Primary Completion Date July 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01202864 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title Ethnic/Racial Variations of Intracerebral Hemorrhage (ERICH)
Official Title Ethnic/Racial Variations of Intracerebral Hemorrhage (ERICH)
Brief Summary The purpose of this study is to find risk factors for hemorrhagic stroke, specifically intracerebral hemorrhage (ICH), among Caucasians, African Americans, and Hispanics.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
whole blood
Sampling Method Non-Probability Sample
Study Population

Our purpose is to enroll 1000 cases of ICH among whites, 1000 cases of ICH among blacks, and 1000 cases of ICH among Hispanics.

3000 controls matched to cases by race/ethnicity, age (+/- 5 years), gender, and geographic location.

Condition Intracerebral Hemorrhage
Intervention Not Provided
Study Groups/Cohorts
  • Cases
    3000 Cases
  • Controls
    3000 Controls
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 Completed
Actual Enrollment
 (submitted: September¬†14,¬†2010)
6000
Original Estimated Enrollment Same as current
Actual Study Completion Date August 1, 2017
Actual Primary Completion Date July 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

All cases must meet the following eligibility criteria:

  1. Age 18 years or greater, fulfillment of the criteria for intracerebral hemorrhage
  2. Resident for at least 6 months within 50 miles of the recruiting center
  3. No evidence of trauma, vascular malformation or aneurysm, or brain tumor as a cause of the hemorrhage
  4. Ability of the patient or legal representative to provide informed consent

Exclusion Criteria:

Exclusion Criteria:

  1. Malignancies leading to coagulopathy
  2. Hemorrhagic transformation of ischemic infarct
  3. Hemorrhage secondary to dural venous sinus thrombosis
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01202864
Other Study ID Numbers 1008059
R01NS069763-01 ( Other Grant/Funding Number: NINDS )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Daniel Woo, University of Cincinnati
Study Sponsor University of Cincinnati
Collaborators
  • Massachusetts General Hospital
  • Columbia University
  • University of Maryland
  • Georgetown University
  • Wake Forest University
  • Emory University
  • University of Miami
  • University of Illinois at Chicago
  • University of Texas, Southwestern Medical Center at Dallas
  • The University of Texas Health Science Center, Houston
  • The University of Texas Health Science Center at San Antonio
  • University of New Mexico
  • University of Arizona
  • University of Southern California
  • St. Luke's-Roosevelt Hospital Center
  • University of California, San Francisco
  • Duke University
  • University of Virginia
  • National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Daniel Woo, MD, MS University of Cincinnati
Principal Investigator: Matthew Flaherty, MD University of Cincinnati
PRS Account University of Cincinnati
Verification Date August 2017