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

• ClinicalTrials.gov Identifier: NCT01202864
• Recruitment Status: Completed
• First Posted: September 16, 2010
• Last Update Posted: September 1, 2017
• Sponsor: University of Cincinnati
• Collaborators: Massachusetts General Hospital; Columbia University; University of Maryland, College Park; 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
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified 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 *

• 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.
• Liu L, Fuller M, Behymer TP, Ng Y, Christianson T, Shah S, King NKK, Woo D, James ML. Selective Serotonin Reuptake Inhibitors and Intracerebral Hemorrhage Risk and Outcome. Stroke. 2020 Apr;51(4):1135-1141. doi: 10.1161/STROKEAHA.119.028406. Epub 2020 Mar 4.
• James ML, Langefeld CD, Sekar P, Moomaw CJ, Elkind MSV, Worrall BB, Sheth KN, Martini SR, Osborne J, Woo D; ERICH Investigators. Assessment of the interaction of age and sex on 90-day outcome after intracerebral hemorrhage. Neurology. 2017 Sep 5;89(10):1011-1019. doi: 10.1212/WNL.0000000000004255. Epub 2017 Jul 14.
• Walsh KB, Woo D, Sekar P, Osborne J, Moomaw CJ, Langefeld CD, Adeoye O. Untreated Hypertension: A Powerful Risk Factor for Lobar and Nonlobar Intracerebral Hemorrhage in Whites, Blacks, and Hispanics. Circulation. 2016 Nov 8;134(19):1444-1452. Epub 2016 Oct 13.

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

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, College Park
• 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