GLOBAL Clinical Study
GLOBAL
Genetic Loci and the Burden of Atherosclerotic Lesions
1 other identifier
observational
10,000
9 countries
48
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2012
Longer than P75 for all trials
48 active sites
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
First Submitted
Initial submission to the registry
November 28, 2012
CompletedFirst Posted
Study publicly available on registry
November 30, 2012
CompletedStudy Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedFebruary 9, 2016
February 1, 2016
1.4 years
November 28, 2012
February 8, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Genome-Wide Association
The primary analysis will be a genome-wide association analysis, to determine candidate genes and markers underlying coronary artery disease.
Baseline
Study Arms (2)
Subjects with CAD
Subjects without CAD
Eligibility Criteria
Patients presenting for clinically indicated coronary CT angiography for an assessment of possible CAD are potential study candidates.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
Heart Center Research
Huntsville, Alabama, United States
The University of Arizona
Tucson, Arizona, United States
Sutter Roseville Medical Center
Roseville, California, United States
Colorado Health Medical Group
Colorado Springs, Colorado, United States
The MedStar Heart Research Institute
Washington D.C., District of Columbia, United States
Elite Research and Clinical Trials
Miami Beach, Florida, United States
Georgia Regents University
Augusta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Iowa Heart Center
West Des Moines, Iowa, United States
Baton Rouge General Medical Center
Baton Rouge, Louisiana, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Detroit Clinical Research Center
Farmington Hills, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
University of Minnesota
Minneapolis, Minnesota, United States
United Heart and Vascular Center
Saint Paul, Minnesota, United States
Midwest Heart and Vascular Specialists
Kansas City, Missouri, United States
Saint Luke's Lipid and Diabetes Research Center
Kansas City, Missouri, United States
Long Island Heart Associates
Mineloa, New York, United States
St. Francis Hospital
Roslyn, New York, United States
Zwanger Pesiri Radiology
Stony Brook, New York, United States
Sentral Clinical Research Services
Cincinnati, Ohio, United States
The Linder Center for Research & Education at The Christ Hospital
Cincinnati, Ohio, United States
University of Cincinnati Physicians Company
Cincinnati, Ohio, United States
Ohio Health Research Institute
Columbus, Ohio, United States
Allegheny Singer Research Institute
Pittsburgh, Pennsylvania, United States
Berks Cardiologists
Wyomissing, Pennsylvania, United States
University of Virginia
Charlottesville, Virginia, United States
Cardiac Study Center
Puyallup, Washington, United States
St. Vincent's Hospital
Darlinghurst, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
The Prince Charles Hospital
Chermside, Queensland, Australia
Greenslopes Private Hospital
Greenslopes, Queensland, Australia
Monash Heart
Clayton, Victoria, Australia
Alfred Hospital
Melbourne, Victoria, Australia
The University of British Columbia
Vancouver, British Columbia, Canada
Poliklinika Sunce
Zagreb, Croatia
University of Erlangen
Erlangen, Germany
Isar Heart Center
Munich, Germany
Semmelweis University
Budapest, Hungary
University of Kaposvar
Kaposvár, Hungary
Meander Medical Center
Amersfoot, Netherlands
Canisius Wilhelmina Ziekenhuis
Nijmegen, Netherlands
Institute of Cardiology
Warsaw, Poland
Ulster Hospital
Belfast, United Kingdom
Liverpool Heart and Chest Hospital
Liverpool, United Kingdom
Royal Liverpool University Hospital
Liverpool, United Kingdom
Plymouth Hospitals NHS Trust of Derriford Hospital
Plymouth, United Kingdom
Related Publications (3)
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.
PMID: 35290075DERIVEDWhitaker 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.
PMID: 33392384DERIVEDVoros 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.
PMID: 25439791DERIVED
Biospecimen
Whole blood, serum, plasma, buffy coat and RNA PAXgene
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Szilard Voros, MD
Global Genomics Group, LLC
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 28, 2012
First Posted
November 30, 2012
Study Start
December 1, 2012
Primary Completion
May 1, 2014
Study Completion
December 1, 2016
Last Updated
February 9, 2016
Record last verified: 2016-02