Genetic and Environmental Risk Factors for Hemorrhagic Stroke-GERFHS III

NCT00930280 | Active Not Recruiting

• 2 other identifiers: 36695-35U01NS036695-16
• Study Type: observational
• Target: 1,260
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find risk factors for hemorrhagic stroke, specifically intracerebral hemorrhage (ICH). ICH, a type of bleeding into brain tissue, is a type of stroke that can result in death or disability in a large number of people. Our study hopes to identify a specific genetic risk factor that will help identify at risk individuals and target treatment strategies.

Conditions

Stroke

Keywords

stroke; brain attack; hemorrhagic stroke; risk factors

Outcome Measures

Primary Outcomes (1)

• The analysis of the presence of specific genetic markers associated with hemorrhagic stroke versus the control group.

  Identification of specific genetic markers for each subject will be measured by gene assay using the Affymetrix chip. We are looking for SNPs that persist after controlling for traditional risk factors such as hypertension, smoking exposure, diabetes, alcohol use, anticoagulant use, hypercholesterolemia and APOE alleles.

  Ongoing to be completed at the end of June 2013.

Secondary Outcomes (1)

• 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.

  Ongoing to be completed at the end of June 2013.

Study Arms (2)

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• N/A

Sponsors & Collaborators

• University of Cincinnati: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

University of Cincinnati Department of Neurology

Cincinnati, Ohio, 45267-0525, United States

Location

Related Publications (36)

• 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: 11988589 BACKGROUND

• Kissela BM, Sauerbeck L, Woo D, Khoury J, Carrozzella J, Pancioli A, Jauch E, Moomaw CJ, Shukla R, Gebel J, Fontaine R, Broderick J. Subarachnoid hemorrhage: a preventable disease with a heritable component. Stroke. 2002 May;33(5):1321-6. doi: 10.1161/01.str.0000014773.57733.3e.

  PMID: 11988610 BACKGROUND

• Woo D, Kissela BM, Khoury JC, Sauerbeck LR, Haverbusch MA, Szaflarski JP, Gebel JM, Pancioli AM, Jauch EC, Schneider A, Kleindorfer D, Broderick JP. Hypercholesterolemia, HMG-CoA reductase inhibitors, and risk of intracerebral hemorrhage: a case-control study. Stroke. 2004 Jun;35(6):1360-4. doi: 10.1161/01.STR.0000127786.16612.A4. Epub 2004 Apr 15.

  PMID: 15087556 BACKGROUND

• Flaherty ML, Woo D, Haverbusch M, Sekar P, Khoury J, Sauerbeck L, Moomaw CJ, Schneider A, Kissela B, Kleindorfer D, Broderick JP. Racial variations in location and risk of intracerebral hemorrhage. Stroke. 2005 May;36(5):934-7. doi: 10.1161/01.STR.0000160756.72109.95. Epub 2005 Mar 24.

  PMID: 15790947 BACKGROUND

• Woo D, Kaushal R, Chakraborty R, Woo J, Haverbusch M, Sekar P, Kissela B, Pancioli A, Jauch E, Kleindorfer D, Flaherty M, Schneider A, Khatri P, Sauerbeck L, Khoury J, Deka R, Broderick J. Association of apolipoprotein E4 and haplotypes of the apolipoprotein E gene with lobar intracerebral hemorrhage. Stroke. 2005 Sep;36(9):1874-9. doi: 10.1161/01.STR.0000177891.15082.b9. Epub 2005 Aug 11.

  PMID: 16100021 BACKGROUND

• Woo D, Sekar P, Chakraborty R, Haverbusch MA, Flaherty ML, Kissela BM, Kleindorfer D, Schneider A, Khoury J, Sauerbeck LR, Deka R, Broderick JP. Genetic epidemiology of intracerebral hemorrhage. J Stroke Cerebrovasc Dis. 2005 Nov-Dec;14(6):239-43. doi: 10.1016/j.jstrokecerebrovasdis.2005.08.002.

  PMID: 16557295 BACKGROUND

• Flaherty ML, Woo D, Haverbusch M, Moomaw CJ, Sekar P, Sauerbeck L, Kissela B, Kleindorfer D, Broderick JP. Potential applicability of recombinant factor VIIa for intracerebral hemorrhage. Stroke. 2005 Dec;36(12):2660-4. doi: 10.1161/01.STR.0000189634.08400.82. Epub 2005 Nov 3.

  PMID: 16269646 BACKGROUND

• Flaherty ML, Haverbusch M, Sekar P, Kissela B, Kleindorfer D, Moomaw CJ, Sauerbeck L, Schneider A, Broderick JP, Woo D. Long-term mortality after intracerebral hemorrhage. Neurology. 2006 Apr 25;66(8):1182-6. doi: 10.1212/01.wnl.0000208400.08722.7c.

  PMID: 16636234 BACKGROUND

• Flaherty ML, Haverbusch M, Sekar P, Kissela BM, Kleindorfer D, Moomaw CJ, Broderick JP, Woo D. Location and outcome of anticoagulant-associated intracerebral hemorrhage. Neurocrit Care. 2006;5(3):197-201. doi: 10.1385/NCC:5:3:197.

  PMID: 17290088 BACKGROUND

• Flaherty ML, Kissela B, Woo D, Kleindorfer D, Alwell K, Sekar P, Moomaw CJ, Haverbusch M, Broderick JP. The increasing incidence of anticoagulant-associated intracerebral hemorrhage. Neurology. 2007 Jan 9;68(2):116-21. doi: 10.1212/01.wnl.0000250340.05202.8b.

  PMID: 17210891 BACKGROUND

• Woo D, Broderick JP. Spontaneous intracerebral hemorrhage: epidemiology and clinical presentation. Neurosurg Clin N Am. 2002 Jul;13(3):265-79, v. doi: 10.1016/s1042-3680(02)00011-6.

  PMID: 12486917 BACKGROUND

• Flaherty ML, Adeoye O, Sekar P, Haverbusch M, Moomaw CJ, Tao H, Broderick JP, Woo D. The challenge of designing a treatment trial for warfarin-associated intracerebral hemorrhage. Stroke. 2009 May;40(5):1738-42. doi: 10.1161/STROKEAHA.108.538462. Epub 2009 Mar 12.

  PMID: 19286588 BACKGROUND

• Flaherty ML, Tao H, Haverbusch M, Sekar P, Kleindorfer D, Kissela B, Khatri P, Stettler B, Adeoye O, Moomaw CJ, Broderick JP, Woo D. Warfarin use leads to larger intracerebral hematomas. Neurology. 2008 Sep 30;71(14):1084-9. doi: 10.1212/01.wnl.0000326895.58992.27.

  PMID: 18824672 BACKGROUND

• Adeoye O, Woo D, Haverbusch M, Tao H, Sekar P, Moomaw CJ, Shutter L, Kleindorfer D, Kissela B, Broderick J, Flaherty ML. Eligibility for the surgical trial in intracerebral hemorrhage II study in a population-based cohort. Neurocrit Care. 2008;9(2):237-41. doi: 10.1007/s12028-007-9045-8.

  PMID: 18183500 BACKGROUND

• Flaherty ML, Woo D, Broderick J. The incidence of deep and lobar intracerebral hemorrhage in whites, blacks, and Hispanics. Neurology. 2006 Mar 28;66(6):956-7; author reply 956-7. doi: 10.1212/01.wnl.0000218670.19577.4c. No abstract available.

  PMID: 16567733 BACKGROUND

• Adeoye O, Woo D, Haverbusch M, Sekar P, Moomaw CJ, Broderick J, Flaherty ML. Surgical management and case-fatality rates of intracerebral hemorrhage in 1988 and 2005. Neurosurgery. 2008 Dec;63(6):1113-7; discussion 1117-8. doi: 10.1227/01.NEU.0000330414.56390.DE.

  PMID: 19057323 BACKGROUND

• Woo D, Haverbusch M, Sekar P, Kissela B, Khoury J, Schneider A, Kleindorfer D, Szaflarski J, Pancioli A, Jauch E, Moomaw C, Sauerbeck L, Gebel J, Broderick J. Effect of untreated hypertension on hemorrhagic stroke. Stroke. 2004 Jul;35(7):1703-8. doi: 10.1161/01.STR.0000130855.70683.c8. Epub 2004 May 20.

  PMID: 15155969 BACKGROUND

• Kharofa J, Sekar P, Haverbusch M, Moomaw C, Flaherty M, Kissela B, Broderick J, Woo D. Selective serotonin reuptake inhibitors and risk of hemorrhagic stroke. Stroke. 2007 Nov;38(11):3049-51. doi: 10.1161/STROKEAHA.107.491472. Epub 2007 Sep 27.

  PMID: 17901378 BACKGROUND

• Adeoye O, Haverbusch M, Woo D, Sekar P, Moomaw CJ, Kleindorfer D, Stettler B, Kissela BM, Broderick JP, Flaherty ML. Is ED disposition associated with intracerebral hemorrhage mortality? Am J Emerg Med. 2011 May;29(4):391-5. doi: 10.1016/j.ajem.2009.10.016. Epub 2010 Mar 25.

  PMID: 20825807 BACKGROUND

• Martini SR, Flaherty ML, Brown WM, Haverbusch M, Comeau ME, Sauerbeck LR, Kissela BM, Deka R, Kleindorfer DO, Moomaw CJ, Broderick JP, Langefeld CD, Woo D. Risk factors for intracerebral hemorrhage differ according to hemorrhage location. Neurology. 2012 Dec 4;79(23):2275-82. doi: 10.1212/WNL.0b013e318276896f. Epub 2012 Nov 21.

  PMID: 23175721 BACKGROUND

• Woo D, Khoury J, Haverbusch MM, Sekar P, Flaherty ML, Kleindorfer DO, Kissela BM, Moomaw CJ, Deka R, Broderick JP. Smoking and family history and risk of aneurysmal subarachnoid hemorrhage. Neurology. 2009 Jan 6;72(1):69-72. doi: 10.1212/01.wnl.0000338567.90260.46.

  PMID: 19122033 BACKGROUND

• Thompson BB, Bejot Y, Caso V, Castillo J, Christensen H, Flaherty ML, Foerch C, Ghandehari K, Giroud M, Greenberg SM, Hallevi H, Hemphill JC 3rd, Heuschmann P, Juvela S, Kimura K, Myint PK, Nagakane Y, Naritomi H, Passero S, Rodriguez-Yanez MR, Roquer J, Rosand J, Rost NS, Saloheimo P, Salomaa V, Sivenius J, Sorimachi T, Togha M, Toyoda K, Turaj W, Vemmos KN, Wolfe CD, Woo D, Smith EE. Prior antiplatelet therapy and outcome following intracerebral hemorrhage: a systematic review. Neurology. 2010 Oct 12;75(15):1333-42. doi: 10.1212/WNL.0b013e3181f735e5. Epub 2010 Sep 8.

  PMID: 20826714 BACKGROUND

• Biffi A, Sonni A, Anderson CD, Kissela B, Jagiella JM, Schmidt H, Jimenez-Conde J, Hansen BM, Fernandez-Cadenas I, Cortellini L, Ayres A, Schwab K, Juchniewicz K, Urbanik A, Rost NS, Viswanathan A, Seifert-Held T, Stoegerer EM, Tomas M, Rabionet R, Estivill X, Brown DL, Silliman SL, Selim M, Worrall BB, Meschia JF, Montaner J, Lindgren A, Roquer J, Schmidt R, Greenberg SM, Slowik A, Broderick JP, Woo D, Rosand J; International Stroke Genetics Consortium. Variants at APOE influence risk of deep and lobar intracerebral hemorrhage. Ann Neurol. 2010 Dec;68(6):934-43. doi: 10.1002/ana.22134.

  PMID: 21061402 BACKGROUND

• Anderson CD, Biffi A, Rahman R, Ross OA, Jagiella JM, Kissela B, Cole JW, Cortellini L, Rost NS, Cheng YC, Greenberg SM, de Bakker PI, Brown RD Jr, Brott TG, Mitchell BD, Broderick JP, Worrall BB, Furie KL, Kittner SJ, Woo D, Slowik A, Meschia JF, Saxena R, Rosand J; International Stroke Genetics Consortium. Common mitochondrial sequence variants in ischemic stroke. Ann Neurol. 2011 Mar;69(3):471-80. doi: 10.1002/ana.22108. Epub 2010 Sep 13.

  PMID: 20839239 BACKGROUND

• He H, Zhang X, Ding L, Baye TM, Kurowski BG, Martin LJ. Effect of population stratification analysis on false-positive rates for common and rare variants. BMC Proc. 2011 Nov 29;5 Suppl 9(Suppl 9):S116. doi: 10.1186/1753-6561-5-S9-S116.

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• Zhang X, He H, Ding L, Baye TM, Kurowski BG, Martin LJ. Family- and population-based designs identify different rare causal variants. BMC Proc. 2011 Nov 29;5 Suppl 9(Suppl 9):S36. doi: 10.1186/1753-6561-5-S9-S36.

  PMID: 22373077 BACKGROUND

• Ding L, Baye TM, He H, Zhang X, Kurowski BG, Martin LJ. Detection of associations with rare and common SNPs for quantitative traits: a nonparametric Bayes-based approach. BMC Proc. 2011 Nov 29;5 Suppl 9(Suppl 9):S10. doi: 10.1186/1753-6561-5-S9-S10.

  PMID: 22373351 BACKGROUND

• Baye TM, He H, Ding L, Kurowski BG, Zhang X, Martin LJ. Population structure analysis using rare and common functional variants. BMC Proc. 2011 Nov 29;5 Suppl 9(Suppl 9):S8. doi: 10.1186/1753-6561-5-S9-S8.

  PMID: 22373300 BACKGROUND

• Biffi A, Anderson CD, Jagiella JM, Schmidt H, Kissela B, Hansen BM, Jimenez-Conde J, Pires CR, Ayres AM, Schwab K, Cortellini L, Pera J, Urbanik A, Romero JM, Rost NS, Goldstein JN, Viswanathan A, Pichler A, Enzinger C, Rabionet R, Norrving B, Tirschwell DL, Selim M, Brown DL, Silliman SL, Worrall BB, Meschia JF, Kidwell CS, Broderick JP, Greenberg SM, Roquer J, Lindgren A, Slowik A, Schmidt R, Woo D, Rosand J; International Stroke Genetics Consortium. APOE genotype and extent of bleeding and outcome in lobar intracerebral haemorrhage: a genetic association study. Lancet Neurol. 2011 Aug;10(8):702-9. doi: 10.1016/S1474-4422(11)70148-X. Epub 2011 Jul 6.

  PMID: 21741316 BACKGROUND

• Woo JG, Martin LJ, Ding L, Brown WM, Howard TD, Langefeld CD, Moomaw CJ, Haverbusch M, Sun G, Indugula SR, Cheng H, Deka R, Woo D. Quantitative criteria for improving performance of buccal DNA for high-throughput genetic analysis. BMC Genet. 2012 Aug 25;13:75. doi: 10.1186/1471-2156-13-75.

  PMID: 22920755 BACKGROUND

• Woo D, Deka R, Falcone GJ, Flaherty ML, Haverbusch M, Martini SR, Greenberg SM, Ayres AM, Sauerbeck L, Kissela BM, Kleindorfer DO, Moomaw CJ, Anderson CD, Broderick JP, Rosand J, Langefeld CD, Woo JG. Apolipoprotein E, statins, and risk of intracerebral hemorrhage. Stroke. 2013 Nov;44(11):3013-7. doi: 10.1161/STROKEAHA.113.001304. Epub 2013 Sep 5.

  PMID: 24008570 BACKGROUND

• Biffi A, Anderson CD, Falcone GJ, Kissela B, Norrving B, Tirschwell DL, Selim M, Brown DL, Silliman SL, Worrall BB, Meschia JF, Kidwell CS, Broderick JP, Greenberg SM, Roquer J, Lindgren A, Slowik A, Schmidt R, Woo D, Rosand J; International Stroke Genetics Consortium. Novel insights into the genetics of intracerebral hemorrhage. Stroke. 2013 Jun;44(6 Suppl 1):S137. doi: 10.1161/STROKEAHA.113.001912. No abstract available.

  PMID: 23709713 BACKGROUND

• Devan WJ, Falcone GJ, Anderson CD, Jagiella JM, Schmidt H, Hansen BM, Jimenez-Conde J, Giralt-Steinhauer E, Cuadrado-Godia E, Soriano C, Ayres AM, Schwab K, Kassis SB, Valant V, Pera J, Urbanik A, Viswanathan A, Rost NS, Goldstein JN, Freudenberger P, Stogerer EM, Norrving B, Tirschwell DL, Selim M, Brown DL, Silliman SL, Worrall BB, Meschia JF, Kidwell CS, Montaner J, Fernandez-Cadenas I, Delgado P, Greenberg SM, Roquer J, Lindgren A, Slowik A, Schmidt R, Woo D, Rosand J, Biffi A; International Stroke Genetics Consortium. Heritability estimates identify a substantial genetic contribution to risk and outcome of intracerebral hemorrhage. Stroke. 2013 Jun;44(6):1578-83. doi: 10.1161/STROKEAHA.111.000089. Epub 2013 Apr 4.

  PMID: 23559261 BACKGROUND

• Adeoye O, Walsh K, Woo JG, Haverbusch M, Moomaw CJ, Broderick JP, Kissela BM, Kleindorfer D, Flaherty ML, Woo D. Peripheral monocyte count is associated with case fatality after intracerebral hemorrhage. J Stroke Cerebrovasc Dis. 2014 Feb;23(2):e107-11. doi: 10.1016/j.jstrokecerebrovasdis.2013.09.006. Epub 2013 Oct 8.

  PMID: 24119622 BACKGROUND

• Woo D, Falcone GJ, Devan WJ, Brown WM, Biffi A, Howard TD, Anderson CD, Brouwers HB, Valant V, Battey TW, Radmanesh F, Raffeld MR, Baedorf-Kassis S, Deka R, Woo JG, Martin LJ, Haverbusch M, Moomaw CJ, Sun G, Broderick JP, Flaherty ML, Martini SR, Kleindorfer DO, Kissela B, Comeau ME, Jagiella JM, Schmidt H, Freudenberger P, Pichler A, Enzinger C, Hansen BM, Norrving B, Jimenez-Conde J, Giralt-Steinhauer E, Elosua R, Cuadrado-Godia E, Soriano C, Roquer J, Kraft P, Ayres AM, Schwab K, McCauley JL, Pera J, Urbanik A, Rost NS, Goldstein JN, Viswanathan A, Stogerer EM, Tirschwell DL, Selim M, Brown DL, Silliman SL, Worrall BB, Meschia JF, Kidwell CS, Montaner J, Fernandez-Cadenas I, Delgado P, Malik R, Dichgans M, Greenberg SM, Rothwell PM, Lindgren A, Slowik A, Schmidt R, Langefeld CD, Rosand J; International Stroke Genetics Consortium. Meta-analysis of genome-wide association studies identifies 1q22 as a susceptibility locus for intracerebral hemorrhage. Am J Hum Genet. 2014 Apr 3;94(4):511-21. doi: 10.1016/j.ajhg.2014.02.012. Epub 2014 Mar 20.

  PMID: 24656865 BACKGROUND

• Stanton RJ, Eckman MH, Woo D, Moomaw CJ, Haverbusch M, Flaherty ML, Kleindorfer DO. Ischemic Stroke and Bleeding: Clinical Benefit of Anticoagulation in Atrial Fibrillation After Intracerebral Hemorrhage. Stroke. 2020 Mar;51(3):808-814. doi: 10.1161/STROKEAHA.119.027370. Epub 2020 Jan 31.

  PMID: 32000590 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Stroke; Hemorrhagic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Daniel Woo, M.D.

  University of Cincinnati Department of Neurology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 29, 2009
• First Posted: June 30, 2009
• Study Start: July 1, 2008
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)