- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01738828
GLOBAL Clinical Study (GLOBAL)
Genetic Loci and the Burden of Atherosclerotic Lesions
The GLOBAL study is an international multi-center, prospective study designed to enroll up to 10,000 consecutive eligible subjects who are clinically referred for coronary CT angiography for assessment of suspected coronary artery disease (CAD).
The purpose of the study is to perform extensive biomarker analysis of atherosclerosis in patients phenotyped using advanced imaging modalities of atherosclerosis.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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New South Wales
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Darlinghurst, New South Wales, Australia
- St. Vincent's Hospital
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St. Leonards, New South Wales, Australia
- Royal North Shore Hospital
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Queensland
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Chermside, Queensland, Australia
- The Prince Charles Hospital
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Greenslopes, Queensland, Australia
- Greenslopes Private Hospital
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Victoria
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Clayton, Victoria, Australia
- Monash Heart
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Melbourne, Victoria, Australia
- Alfred Hospital
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British Columbia
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Vancouver, British Columbia, Canada
- The University of British Columbia
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Zagreb, Croatia
- Poliklinika Sunce
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Erlangen, Germany
- University of Erlangen
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Munich, Germany
- Isar Heart Center
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Budapest, Hungary
- Semmelweis University
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Kaposvar, Hungary
- University of Kaposvar
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Amersfoot, Netherlands
- Meander Medical Center
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Nijmegen, Netherlands
- Canisius Wilhelmina Ziekenhuis
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Warsaw, Poland
- Institute of Cardiology
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Belfast, United Kingdom
- Ulster Hospital
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Liverpool, United Kingdom
- Royal Liverpool University Hospital
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Liverpool, United Kingdom
- Liverpool Heart and Chest Hospital
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Plymouth, United Kingdom
- Plymouth Hospitals NHS Trust of Derriford Hospital
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Alabama
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Huntsville, Alabama, United States
- Heart Center Research
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Arizona
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Tucson, Arizona, United States
- The University of Arizona
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California
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Roseville, California, United States
- Sutter Roseville Medical Center
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Colorado
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Colorado Springs, Colorado, United States
- Colorado Health Medical Group
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District of Columbia
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Washington, District of Columbia, United States
- The MedStar Heart Research Institute
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Florida
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Miami Beach, Florida, United States
- Elite Research and Clinical Trials
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Georgia
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Augusta, Georgia, United States
- Georgia Regents University
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Illinois
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Chicago, Illinois, United States
- University of Chicago
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Iowa
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West Des Moines, Iowa, United States
- Iowa Heart Center
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Louisiana
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Baton Rouge, Louisiana, United States
- Baton Rouge General Medical Center
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Maryland
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Bethesda, Maryland, United States
- Walter Reed National Military Medical Center
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Michigan
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Farmington Hills, Michigan, United States
- Detroit Clinical Research Center
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Royal Oak, Michigan, United States
- William Beaumont Hospital
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Minnesota
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Minneapolis, Minnesota, United States
- University of Minnesota
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Minneapolis, Minnesota, United States
- Minneapolis Heart Institute Foundation
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St. Paul, Minnesota, United States
- United Heart and Vascular Center
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Missouri
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Kansas City, Missouri, United States
- Midwest Heart and Vascular Specialists
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Kansas City, Missouri, United States
- Saint Luke's Lipid and Diabetes Research Center
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New York
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Mineloa, New York, United States
- Long Island Heart Associates
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Roslyn, New York, United States
- St. Francis Hospital
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Stony Brook, New York, United States
- Zwanger Pesiri Radiology
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Ohio
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Cincinnati, Ohio, United States
- Sentral Clinical Research Services
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Cincinnati, Ohio, United States
- The Linder Center for Research & Education at The Christ Hospital
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Cincinnati, Ohio, United States
- University of Cincinnati Physicians Company
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Columbus, Ohio, United States
- Ohio Health Research Institute
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Pennsylvania
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Pittsburgh, Pennsylvania, United States
- Allegheny Singer Research Institute
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Wyomissing, Pennsylvania, United States
- Berks Cardiologists
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Virginia
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Charlottesville, Virginia, United States
- University of Virginia
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Washington
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Puyallup, Washington, United States
- Cardiac Study Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Ages 18-90
- Caucasian and of Non-Hispanic or Non-Latino origin
- Referral for coronary CT angiography to evaluate for presence of CAD
- The patient has signed the appropriate Institutional Review Board approved Informed Consent Form
Exclusion Criteria:
- Immunosuppressive or immunomodulatory therapy including any dose of systemic corticosteroids in the preceding 30 days (except if steroids are administered as pre-medication prior to contrast administration for CT scan within 24 hours).
- Chemotherapy in the preceding year
- Major surgery in the preceding 2 months
- Blood or blood product transfusion in the preceding 2 months
- Subjects for whom coronary CT angiography is contraindicated per institutional standard of care
- Subjects with previous coronary arterial revascularization (PCI or CABG)
- Subjects with atrial fibrillation/flutter or frequent irregular or rapid heart rhythms, which occurred within the past 3 months
- Subjects with a pacemaker or implantable cardioverter-defibrillator implant
- Active congestive heart failure or the presence of known non-ischemic cardiomyopathy
- Known genetic disorders of atherosclerosis, lipid or lipoprotein metabolism
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Subjects with CAD
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Subjects without CAD
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Genome-Wide Association
Time Frame: Baseline
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The primary analysis will be a genome-wide association analysis, to determine candidate genes and markers underlying coronary artery disease.
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Baseline
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Szilard Voros, MD, Global Genomics Group, LLC
Publications and helpful links
General Publications
- Drobni ZD, Kolossvary M, Karady J, Jermendy AL, Tarnoki AD, Tarnoki DL, Simon J, Szilveszter B, Littvay L, Voros S, Jermendy G, Merkely B, Maurovich-Horvat P. Heritability of Coronary Artery Disease: Insights From a Classical Twin Study. Circ Cardiovasc Imaging. 2022 Mar;15(3):e013348. doi: 10.1161/CIRCIMAGING.121.013348. Epub 2022 Mar 15.
- Whitaker J, Karady J, Karim R, Tobon-Gomez C, Fastl T, Razeghi O, O'Neill L, Decroocq M, Williams S, Corrado C, Mukherjee RK, Sim I, O'Hare D, Kotadia I, Kolossvary M, Merkely B, Littvay L, Tarnoki AD, Tarnoki DL, Voros S, Razavi R, O'Neill M, Rajani R, Maurovich Horvat P, Niederer S. Standardised computed tomographic assessment of left atrial morphology and tissue thickness in humans. Int J Cardiol Heart Vasc. 2020 Dec 24;32:100694. doi: 10.1016/j.ijcha.2020.100694. eCollection 2021 Feb.
- Voros S, Maurovich-Horvat P, Marvasty IB, Bansal AT, Barnes MR, Vazquez G, Murray SS, Voros V, Merkely B, Brown BO, Warnick GR. Precision phenotyping, panomics, and system-level bioinformatics to delineate complex biologies of atherosclerosis: rationale and design of the "Genetic Loci and the Burden of Atherosclerotic Lesions" study. J Cardiovasc Comput Tomogr. 2014 Nov-Dec;8(6):442-51. doi: 10.1016/j.jcct.2014.08.006. Epub 2014 Sep 6.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR0001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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