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AzTrials

StrokeGERFHSNCT00682695

Genetic and Environmental Risk Factors for Hemorrhagic Stroke

An observational study of Stroke, run by State University of New York at Buffalo at 7 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to find risk factors for hemorrhagic stroke. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Stroke
How many people
1,000 participants
Where
7 sitesUnited States
Study dates
1 Jan 2025to 31 Dec 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: This study will be limited to physician-reviewed cases of people who have had a hemorrhagic stroke.

Who may be able to join

  • Age 18 or older
  • Resident (6 months or longer) within the recruitment center
  • Fulfillment of the criteria for spontaneous ICH
  • No evidence of trauma, brain tumor/metastases 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

Who cannot join

  • N/A

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lee A Gilkerson, RN, BSN contact

513-558-6140

Lee.gilkerson@uc.edu

7 sites in 1 country

United States7 sites, 7 recruiting
  • University of Maryland

    Baltimore, Maryland, 21201

    Tiffany Watson, 410-706-1902, tiwatson@som.umaryland.edu

    Steven Kittner, MD

    Recruiting
  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Christina Kourkoulis, 617-726-5358, CKOURKOULIS@PARTNERS.ORG

    Jonathan R, MD

    Recruiting
  • University of Illinois Chicago

    Chicago, Illinois, 60612

    Maureen Hillman, 3123553863, hillmann@uic.edu

    Fernando Testai, M.D.

    Not yet recruiting
  • University of Cincinnati

    Cincinnati, Ohio, 45267

    Lee A Gilkerson, RN, BSN, 513-558-6140, Lee.gilkerson@uc.edu

    Daniel Woo, MD

    Recruiting
  • Duke University

    Durham, North Carolina, 27710

    Andreea Podgoreanu, 919-681-4054, andrea.podgoreanu@duke.edu

    Michael L James, MD

    Recruiting
  • Baptist Health Louisville

    Louisville, Kentucky, 40207

    Karin Cryan, 5022595564, karin.cryan@BHSI.COM

    Ranjit Bagga, MD

    Recruiting
  • Columbia University

    New York, New York, 10032

    Angela Velazquez, 212-305-6071, aqv2113@cumc.columbia.edu

    David Roh, M.D.

    Not yet recruiting

Other trials in United States

About this study

The purpose of this study is to find risk factors for hemorrhagic stroke.

Read the detailed description

The proposed research builds on the most robust, statistically significant and replicated association identified to determine the mechanism by which it may relate to intracerebral hemorrhage (ICH) risk. Given that ICH is an extreme phenotype on a spectrum of manifestations of cerebral small vessel disease, the findings that emerge from our proposed studies offer the promise of broad impact for research and treatment in a wide variety of cerebrovascular disorders.

In the genetic epidemiology of hemorrhagic stroke, we propose to perform an in-depth fine-mapping of the entire 1q22 genomic region (~250kb) to investigate whether genetic variants influence gene expression that correlates with ICH status or changes in expression over time in ICH cases. As existing samples were not processed for gene expression analysis, we will recruit 500 non-lobar ICH cases (~150 black, ~350 white) and 1000 controls (300 black, 700 white) to correlate sequence variation with gene expression levels in the same samples. Identified associations will be replicated in 6,000 cases of ICH and 9,361 individuals in the CHARGE consortium with MRI white matter hyperintensity volume measurements and 5,000 controls. The current proposal takes the next logical step by pursuing the most promising findings of our Genome-Wide Association Study (GWAS) to complete the following aims:

Specific Aim #1: Perform deep DNA sequencing of Chr 1q22 among non-Hispanic white and black ICH cases and controls to identify all genomic variation within these regions and test the following:

Hypothesis #1a: Variants strongly associated with ICH risk at 1q22 are either directly causal or in linkage disequilibrium to causal variants that influence ICH risk, and sequencing of these regions will reveal both common and rare variants that exert this causal influence.

Hypothesis #1b: Variants strongly associated with ICH risk at 1q22 will be associated with risk of, or severity of, leukoaraiosis.

Specific Aim #2: Prospectively collect DNA, RNA, and serum on ICH cases and geographic region site-specific controls both at the time of ICH and in the convalescent period. We will perform RNA expression profiling between cases and controls and over time in cases. We will compute expression quantitative trait locus (eQTL) analysis with Single Nucleotide Polymorphisms (SNPs) arising from Aim 1. We will also determine whether alternatively spliced transcripts differ between cases and controls.

Hypothesis #2a: Variation in gene expression or alternatively spliced transcripts affects risk of ICH.

Hypothesis #2b: Variations identified by DNA sequencing will affect gene expression and/or alternatively spliced transcripts that affect risk of ICH.

Conditions
Stroke
Keywords
stroke, brain attack, hemorrhagic stroke, risk factors
Medical subject headings
Stroke, Hemorrhagic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00682695
Study groupRoleWhat they receive
1Participants who have had a hemorrhagic stroke at University of Maryland, University of Cincinnati, Massachusetts General Hospital, Duke University, Columbia University and University of Chicago Illinois, age 18 years or greater. Ability of the patient or legal representative to provide informed consent. Racial/ethnic category meets one of the following: African American, Caucasian or Hispanic. Healthy volunteers who are matched to the study cases with hemorrhagic stroke within +/- 5 years of age, same gender and same race.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Perform deep DNA sequencing of Chr 1q22

    Perform deep DNA sequencing of Chr 1q22 among non-Hispanic white and black ICH cases and controls to identify all genomic variation within these regions.

    Measured: Ongoing to be completed at the end of June 2021

Secondary outcomes (1)
  1. Collect and analyze DNA, RNA, and serum on ICH cases and matched control participants.

    Collect and analyze DNA, RNA, and serum on ICH cases and matched controls both at the time of ICH and in the convalescent period. We will perform RNA expression profiling between cases and controls and over time in cases.

    Measured: Ongoing to be completed at the end of June 2021

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2008 (estimated)
  2. Study start1 Jan 2025
  3. Primary completion31 Dec 2029 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00682695
Sponsor's protocol ID
NS36695
Other IDs
2U01NS036695-15A1
Acronym
GERFHS
Status last verified
Jul 2026
First submitted
20 May 2008
Last updated
2 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 11988589
  • 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.

    PubMed 11988610
  • 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.

    PubMed 15087556
  • 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.

    PubMed 15155969
  • 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.

    PubMed 15790947
  • Sauerbeck LR, Khoury JC, Woo D, Kissela BM, Moomaw CJ, Broderick JP. Smoking cessation after stroke: education and its effect on behavior. J Neurosci Nurs. 2005 Dec;37(6):316-9, 325.

    PubMed 16396084
  • 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.

    PubMed 16100021
  • 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.

    PubMed 16557295
  • Flaherty ML, Haverbusch M, Kissela B, Kleindorfer D, Schneider A, Sekar P, Moomaw CJ, Sauerbeck L, Broderick JP, Woo D. Perimesencephalic subarachnoid hemorrhage: incidence, risk factors, and outcome. J Stroke Cerebrovasc Dis. 2005 Nov-Dec;14(6):267-71. doi: 10.1016/j.jstrokecerebrovasdis.2005.07.004.

    PubMed 16518463
  • 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.

    PubMed 16269646
  • Woo D, Kaushal R, Kissela B, Sekar P, Wolujewicz M, Pal P, Alwell K, Haverbusch M, Ewing I, Miller R, Kleindorfer D, Flaherty M, Chakraborty R, Deka R, Broderick J. Association of Phosphodiesterase 4D with ischemic stroke: a population-based case-control study. Stroke. 2006 Feb;37(2):371-6. doi: 10.1161/01.STR.0000198843.72824.0a. Epub 2005 Dec 22.

    PubMed 16373644
  • 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.

    PubMed 16636234
  • 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.

    PubMed 17290088
  • Kaushal R, Pal P, Alwell K, Haverbusch M, Flaherty M, Moomaw C, Sekar P, Kissela B, Kleindorfer D, Chakraborty R, Broderick J, Deka R, Woo D. Association of ALOX5AP with ischemic stroke: a population-based case-control study. Hum Genet. 2007 Jun;121(5):601-7. doi: 10.1007/s00439-007-0338-y. Epub 2007 Mar 27.

    PubMed 17387518
  • Eden SV, Morgenstern LB, Sekar P, Moomaw CJ, Haverbusch M, Flaherty ML, Broderick JP, Woo D. The role of race in time to treatment after subarachnoid hemorrhage. Neurosurgery. 2007 May;60(5):837-43; discussion 837-43. doi: 10.1227/01.NEU.0000255451.82483.50.

    PubMed 17460518

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke, run by State University of New York at Buffalo at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lee A Gilkerson, RN, BSN (513-558-6140, Lee.gilkerson@uc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perform deep DNA sequencing of Chr 1q22 (time frame: Ongoing to be completed at the end of June 2021). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00682695, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.

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