NCT01202864

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2010

Longer than P75 for all trials

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 14, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2010

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2017

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

September 1, 2017

Status Verified

August 1, 2017

Enrollment Period

7 years

First QC Date

September 14, 2010

Last Update Submit

August 31, 2017

Conditions

Intracerebral Hemorrhage

Keywords

Intracerebral HemorrhageICHStrokeCerebrovascular accident

Study Arms (2)

Cases

3000 Cases

Controls

3000 Controls

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

University of Arizona

Tucson, Arizona, 85724, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

University of Miami - Biorepository

Miami, Florida, 33136, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Emory University

Atlanta, Georgia, 30303, United States

Location

University of Illinois

Chicago, Illinois, 60612, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

University of Texas Medical School at Houston

Houston, Texas, 77030, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Related Publications (22)

  • 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. doi: 10.1161/01.str.27.9.1459.

    PMID: 8784113BACKGROUND

  • 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. doi: 10.1161/01.str.0000014774.88027.22.

    PMID: 11988589BACKGROUND

  • 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. doi: 10.1161/01.STR.0000110982.74967.39.

    PMID: 14757893BACKGROUND

  • 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. doi: 10.1161/01.STR.0000082382.42061.EE. Epub 2003 Jul 3.

    PMID: 12843343BACKGROUND

  • 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. doi: 10.1161/01.str.20.5.577.

    PMID: 2718196BACKGROUND

  • 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. doi: 10.3171/jns.1993.78.2.0188.

    PMID: 8421201BACKGROUND

  • 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. doi: 10.1002/gps.1041.

    PMID: 14716702BACKGROUND

  • 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. doi: 10.1002/gps.830.

    PMID: 12673608BACKGROUND

  • MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.

    PMID: 14258950BACKGROUND

  • RANKIN J. Cerebral vascular accidents in patients over the age of 60. II. Prognosis. Scott Med J. 1957 May;2(5):200-15. doi: 10.1177/003693305700200504. No abstract available.

    PMID: 13432835BACKGROUND

  • 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. doi: 10.1212/01.wnl.0000138428.40673.83.

    PMID: 15452298BACKGROUND

  • 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. doi: 10.1212/01.wnl.0000257087.22852.21.

    PMID: 17372123BACKGROUND

  • 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.

    PMID: 19242340BACKGROUND

  • 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. doi: 10.1161/01.str.28.1.1.

    PMID: 8996478BACKGROUND

  • 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. doi: 10.1212/01.wnl.0000208408.98482.99.

    PMID: 16636233BACKGROUND

  • 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.

    PMID: 18480205BACKGROUND

  • Behymer TP, Sekar P, Demel SL, Aziz YN, Coleman ER, Williamson BJ, Stanton RJ, Sawyer RP, Turner AC, Vagal VS, Osborne J, Gilkerson LA, Comeau ME, Flaherty ML, Langefeld CD, Woo D. Psychosocial Stress and Risk for Intracerebral Hemorrhage in the ERICH (Ethnic/Racial Variations of Intracerebral Hemorrhage) Study. J Am Heart Assoc. 2025 Mar 18;14(6):e024457. doi: 10.1161/JAHA.121.024457. Epub 2025 Mar 7.

    PMID: 40055853DERIVED

  • Ridha M, Hannawi Y, Murthy S, Carvalho Poyraz F, Kumar A, Park S, Roh D, Sekar P, Woo D, Burke J. Premorbid Blood Pressure Control Modifies Risk of DWI Lesions With Acute Blood Pressure Reduction in Intracerebral Hemorrhage. Hypertension. 2024 Oct;81(10):2113-2123. doi: 10.1161/HYPERTENSIONAHA.124.23271. Epub 2024 Jul 29.

    PMID: 39069917DERIVED

  • Ng Y, Qi W, King NKK, Christianson T, Krishnamoorthy V, Shah S, Divani A, Bettin M, Coleman ER, Flaherty ML, Walsh KB, Testai FD, McCauley JL, Gilkerson LA, Langefeld CD, Behymer TP, Woo D, James ML. Initial antihypertensive agent effects on acute blood pressure after intracerebral haemorrhage. Stroke Vasc Neurol. 2022 Oct;7(5):367-374. doi: 10.1136/svn-2021-001101. Epub 2022 Apr 20.

    PMID: 35443984DERIVED

  • 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.

    PMID: 32126942DERIVED

  • 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.

    PMID: 28710330DERIVED

  • 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. doi: 10.1161/CIRCULATIONAHA.116.024073. Epub 2016 Oct 13.

    PMID: 27737957DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Cerebral HemorrhageStroke

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Daniel Woo, MD, MS

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

  • Matthew Flaherty, MD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 14, 2010

First Posted

September 16, 2010

Study Start

August 1, 2010

Primary Completion

July 31, 2017

Study Completion

August 1, 2017

Last Updated

September 1, 2017

Record last verified: 2017-08

Locations

US(15)