Coronary Artery DiseaseGLOBALNCT01738828
GLOBAL Clinical Study
An observational study of Coronary Artery Disease, run by Global Genomics Group, LLC at 48 sites in 9 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 10,000 participants
- Where
- 48 sitesin 9 countries
- Study dates
- Dec 2012to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting for clinically indicated coronary CT angiography for an assessment of possible CAD are potential study candidates.
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
48 sites in 9 countries.
48 sites in 9 countries
United States29 sites
Georgia Regents University
Augusta, Georgia
Baton Rouge General Medical Center
Baton Rouge, Louisiana
Walter Reed National Military Medical Center
Bethesda, Maryland
University of Virginia
Charlottesville, Virginia
University of Chicago
Chicago, Illinois
Sentral Clinical Research Services
Cincinnati, Ohio
The Linder Center for Research & Education at The Christ Hospital
Cincinnati, Ohio
University of Cincinnati Physicians Company
Cincinnati, Ohio
Colorado Health Medical Group
Colorado Springs, Colorado
Ohio Health Research Institute
Columbus, Ohio
Detroit Clinical Research Center
Farmington Hills, Michigan
Heart Center Research
Huntsville, Alabama
Midwest Heart and Vascular Specialists
Kansas City, Missouri
Saint Luke's Lipid and Diabetes Research Center
Kansas City, Missouri
Elite Research and Clinical Trials
Miami Beach, Florida
Long Island Heart Associates
Mineloa, New York
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota
University of Minnesota
Minneapolis, Minnesota
Allegheny Singer Research Institute
Pittsburgh, Pennsylvania
Cardiac Study Center
Puyallup, Washington
Sutter Roseville Medical Center
Roseville, California
St. Francis Hospital
Roslyn, New York
William Beaumont Hospital
Royal Oak, Michigan
United Heart and Vascular Center
Saint Paul, Minnesota
Zwanger Pesiri Radiology
Stony Brook, New York
The University of Arizona
Tucson, Arizona
The MedStar Heart Research Institute
Washington D.C., District of Columbia
Iowa Heart Center
West Des Moines, Iowa
Berks Cardiologists
Wyomissing, Pennsylvania
Australia6 sites
The Prince Charles Hospital
Chermside, Queensland
Monash Heart
Clayton, Victoria
St. Vincent's Hospital
Darlinghurst, New South Wales
Greenslopes Private Hospital
Greenslopes, Queensland
Alfred Hospital
Melbourne, Victoria
Royal North Shore Hospital
St Leonards, New South Wales
United Kingdom4 sites
Ulster Hospital
Belfast
Liverpool Heart and Chest Hospital
Liverpool
Royal Liverpool University Hospital
Liverpool
Plymouth Hospitals NHS Trust of Derriford Hospital
Plymouth
Netherlands2 sites
Meander Medical Center
Amersfoot
Canisius Wilhelmina Ziekenhuis
Nijmegen
About this study
Official title: 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.
- Conditions
- Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with CAD | Not described | |
| Subjects without CAD | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genome-Wide Association
The primary analysis will be a genome-wide association analysis, to determine candidate genes and markers underlying coronary artery disease.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startDec 2012
- Primary completionMay 2014
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Global Genomics Group, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Szilard Voros, MD, Study director, Global Genomics Group, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01738828
- Sponsor's protocol ID
- CR0001
- Acronym
- GLOBAL
- Status last verified
- Feb 2016
- First submitted
- 28 Nov 2012
- Last updated
- 9 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Voros S, Barnes MR, Watson D, Boatwright W, Lozama A, Yates D, Narula J, Marcovina S. Unraveling Emerging Data on Lipoprotein(a)-Driven Cardiovascular Disease via Multiomics: A Review. Glob Heart. 2026 Mar 23;21(1):25. doi: 10.5334/gh.1540. eCollection 2026.
PubMed 41908166Drobni 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.
PubMed 35290075Whitaker 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.
PubMed 33392384Voros 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.
PubMed 25439791
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Loci and the Burden of Atherosclerotic Lesions
- ClinicalTrials.gov ID
- NCT01738828
- Acronym / sponsor ID
- GLOBAL / CR0001
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Global Genomics Group, LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- May 2014 (actual)
- Study completion
- Dec 2016 (estimated)
- First posted
- 30 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with CAD | – | – |
| Subjects without CAD | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting for clinically indicated coronary CT angiography for an assessment of possible CAD are potential study candidates.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Genome-Wide Association
Time frame: Baseline
The primary analysis will be a genome-wide association analysis, to determine candidate genes and markers underlying coronary artery disease.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2016.
- Derived from this study: PubMed 41908166Voros S, Barnes MR, Watson D, Boatwright W, Lozama A, Yates D, Narula J, Marcovina S. Unraveling Emerging Data on Lipoprotein(a)-Driven Cardiovascular Disease via Multiomics: A Review. Glob Heart. 2026 Mar 23;21(1):25. doi: 10.5334/gh.1540. eCollection 2026.
- Derived from this study: PubMed 35290075Drobni 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.
- Derived from this study: PubMed 33392384Whitaker 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.
- Derived from this study: PubMed 25439791Voros 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Szilard Voros, MD study director
Global Genomics Group, LLC
48 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Global Genomics Group, LLC at 48 sites in 9 countries.
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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 9 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States, Australia, United Kingdom, Germany, Hungary and 4 more countries. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genome-Wide Association (time frame: Baseline). 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 NCT01738828, which also lists 4 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 9 Feb 2016.