Ethnic/Racial Variations of Intracerebral Hemorrhage (ERICH)

This study is enrolling participants by invitation only.

Sponsor:

Collaborators:

Massachusetts General Hospital

Columbia University

University of Maryland

Georgetown University

Wake Forest School of Medicine

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

UCSF - Fresno

Duke University

University of Virginia

National Institute of Neurological Disorders and Stroke (NINDS)

Information provided by (Responsible Party):

Daniel Woo, University of Cincinnati

ClinicalTrials.gov Identifier:

NCT01202864

First received: September 14, 2010

Last updated: May 19, 2014

Last verified: May 2014

History of Changes

Purpose

The purpose of this study is to find risk factors for hemorrhagic stroke, specifically intracerebral hemorrhage (ICH), among Caucasians, African Americans, and Hispanics.

Condition
Intracerebral Hemorrhage


Study Type:	Observational
Study Design:	Observational Model: Case Control
Official Title:	Ethnic/Racial Variations of Intracerebral Hemorrhage (ERICH)

Resource links provided by NLM:

Genetics Home Reference related topics: COL4A1-related brain small-vessel disease

MedlinePlus related topics: Bleeding

U.S. FDA Resources

Further study details as provided by University of Cincinnati:

Biospecimen Retention: Samples With DNA

whole blood


Estimated Enrollment:	6000
Study Start Date:	August 2010
Estimated Study Completion Date:	March 2015
Estimated Primary Completion Date:	March 2015 (Final data collection date for primary outcome measure)

Groups/Cohorts
Cases 3000 Cases
Controls 3000 Controls

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

Criteria

Inclusion Criteria:

All cases must meet the following eligibility criteria:

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

Exclusion Criteria:

Malignancies leading to coagulopathy
Hemorrhagic transformation of ischemic infarct
Hemorrhage secondary to dural venous sinus thrombosis

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: NCT01202864

Locations


United States, Arizona
University of Arizona
Tucson, Arizona, United States, 85724
United States, California
University of Southern California
Los Angeles, California, United States, 90033
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20007
United States, Florida
University of Miami
Miami, Florida, United States, 33136
University of Miami - Biorepository
Miami, Florida, United States, 33136
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30303
United States, Illinois
University of Illinois
Chicago, Illinois, United States, 60612
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
United States, New York
Columbia University
New York City, New York, United States, 10032
United States, North Carolina
Wake Forest University
Winston-Salem, North Carolina, United States, 27157
United States, Texas
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390
University of Texas Medical School at Houston
Houston, Texas, United States, 77030
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229

Sponsors and Collaborators

University of Cincinnati

Massachusetts General Hospital

Columbia University

University of Maryland

Georgetown University

Wake Forest School of Medicine

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

UCSF - Fresno

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

More Information

Publications:

Taylor TN, Davis PH, Torner JC, Holmes J, Meyer JW, Jacobson MF. Lifetime cost of stroke in the United States. Stroke. 1996 Sep;27(9):1459-66. Review.

Woo D, Sauerbeck LR, Kissela BM, Khoury JC, Szaflarski JP, Gebel J, Shukla R, Pancioli AM, Jauch EC, Menon AG, Deka R, Carrozzella JA, Moomaw CJ, Fontaine RN, Broderick JP. Genetic and environmental risk factors for intracerebral hemorrhage: preliminary results of a population-based study. Stroke. 2002 May;33(5):1190-5.

Kissela B, Schneider A, Kleindorfer D, Khoury J, Miller R, Alwell K, Woo D, Szaflarski J, Gebel J, Moomaw C, Pancioli A, Jauch E, Shukla R, Broderick J. Stroke in a biracial population: the excess burden of stroke among blacks. Stroke. 2004 Feb;35(2):426-31.

Hardie K, Hankey GJ, Jamrozik K, Broadhurst RJ, Anderson C. Ten-year survival after first-ever stroke in the perth community stroke study. Stroke. 2003 Aug;34(8):1842-6. Epub 2003 Jul 3.

Broderick JP, Phillips SJ, Whisnant JP, O'Fallon WM, Bergstralh EJ. Incidence rates of stroke in the eighties: the end of the decline in stroke? Stroke. 1989 May;20(5):577-82.

Broderick JP, Brott T, Tomsick T, Miller R, Huster G. Intracerebral hemorrhage more than twice as common as subarachnoid hemorrhage. J Neurosurg. 1993 Feb;78(2):188-91.

Barber M, Stott DJ. Validity of the Telephone Interview for Cognitive Status (TICS) in post-stroke subjects. Int J Geriatr Psychiatry. 2004 Jan;19(1):75-9.

de Jager CA, Budge MM, Clarke R. Utility of TICS-M for the assessment of cognitive function in older adults. Int J Geriatr Psychiatry. 2003 Apr;18(4):318-24.

MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5.

RANKIN J. Cerebral vascular accidents in patients over the age of 60. II. Prognosis. Scott Med J. 1957 May;2(5):200-15.

Flibotte JJ, Hagan N, O'Donnell J, Greenberg SM, Rosand J. Warfarin, hematoma expansion, and outcome of intracerebral hemorrhage. Neurology. 2004 Sep 28;63(6):1059-64.

Goldstein JN, Fazen LE, Snider R, Schwab K, Greenberg SM, Smith EE, Lev MH, Rosand J. Contrast extravasation on CT angiography predicts hematoma expansion in intracerebral hemorrhage. Neurology. 2007 Mar 20;68(12):889-94.

Kumar MA, Rost NS, Snider RW, Chanderraj R, Greenberg SM, Smith EE, Rosand J. Anemia and hematoma volume in acute intracerebral hemorrhage. Crit Care Med. 2009 Apr;37(4):1442-7. doi: 10.1097/CCM.0b013e31819ced3a.

Brott T, Broderick J, Kothari R, Barsan W, Tomsick T, Sauerbeck L, Spilker J, Duldner J, Khoury J. Early hemorrhage growth in patients with intracerebral hemorrhage. Stroke. 1997 Jan;28(1):1-5.

Davis SM, Broderick J, Hennerici M, Brun NC, Diringer MN, Mayer SA, Begtrup K, Steiner T; Recombinant Activated Factor VII Intracerebral Hemorrhage Trial Investigators. Hematoma growth is a determinant of mortality and poor outcome after intracerebral hemorrhage. Neurology. 2006 Apr 25;66(8):1175-81.

Mayer SA, Brun NC, Begtrup K, Broderick J, Davis S, Diringer MN, Skolnick BE, Steiner T; FAST Trial Investigators. Efficacy and safety of recombinant activated factor VII for acute intracerebral hemorrhage. N Engl J Med. 2008 May 15;358(20):2127-37. doi: 10.1056/NEJMoa0707534.


Responsible Party:	Daniel Woo, Professor, University of Cincinnati
ClinicalTrials.gov Identifier:	NCT01202864 History of Changes
Other Study ID Numbers:	1008059, R01NS069763-01
Study First Received:	September 14, 2010
Last Updated:	May 19, 2014
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Cincinnati:


Intracerebral Hemorrhage ICH Stroke CVA

Additional relevant MeSH terms:


Cerebral Hemorrhage Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases	Cerebrovascular Disorders Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Vascular Diseases

ClinicalTrials.gov processed this record on March 01, 2015

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