GLOBAL Clinical Study

NCT ID: NCT01738828

Last Updated: 2016-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects with CAD

No interventions assigned to this group

Subjects without CAD

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Ages 18-90
2. Caucasian and of Non-Hispanic or Non-Latino origin
3. Referral for coronary CT angiography to evaluate for presence of CAD
4. The patient has signed the appropriate Institutional Review Board approved Informed Consent Form

Exclusion Criteria

1. 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).
2. Chemotherapy in the preceding year
3. Major surgery in the preceding 2 months
4. Blood or blood product transfusion in the preceding 2 months
5. Subjects for whom coronary CT angiography is contraindicated per institutional standard of care
6. Subjects with previous coronary arterial revascularization (PCI or CABG)
7. Subjects with atrial fibrillation/flutter or frequent irregular or rapid heart rhythms, which occurred within the past 3 months
8. Subjects with a pacemaker or implantable cardioverter-defibrillator implant
9. Active congestive heart failure or the presence of known non-ischemic cardiomyopathy
10. Known genetic disorders of atherosclerosis, lipid or lipoprotein metabolism
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Global Genomics Group, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Szilard Voros, MD

Role: STUDY_DIRECTOR

Global Genomics Group, LLC

Locations

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Heart Center Research

Huntsville, Alabama, United States

Site Status

The University of Arizona

Tucson, Arizona, United States

Site Status

Sutter Roseville Medical Center

Roseville, California, United States

Site Status

Colorado Health Medical Group

Colorado Springs, Colorado, United States

Site Status

The MedStar Heart Research Institute

Washington D.C., District of Columbia, United States

Site Status

Elite Research and Clinical Trials

Miami Beach, Florida, United States

Site Status

Georgia Regents University

Augusta, Georgia, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

Iowa Heart Center

West Des Moines, Iowa, United States

Site Status

Baton Rouge General Medical Center

Baton Rouge, Louisiana, United States

Site Status

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Site Status

Detroit Clinical Research Center

Farmington Hills, Michigan, United States

Site Status

William Beaumont Hospital

Royal Oak, Michigan, United States

Site Status

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

Site Status

University of Minnesota

Minneapolis, Minnesota, United States

Site Status

United Heart and Vascular Center

Saint Paul, Minnesota, United States

Site Status

Midwest Heart and Vascular Specialists

Kansas City, Missouri, United States

Site Status

Saint Luke's Lipid and Diabetes Research Center

Kansas City, Missouri, United States

Site Status

Long Island Heart Associates

Mineloa, New York, United States

Site Status

St. Francis Hospital

Roslyn, New York, United States

Site Status

Zwanger Pesiri Radiology

Stony Brook, New York, United States

Site Status

Sentral Clinical Research Services

Cincinnati, Ohio, United States

Site Status

The Linder Center for Research & Education at The Christ Hospital

Cincinnati, Ohio, United States

Site Status

University of Cincinnati Physicians Company

Cincinnati, Ohio, United States

Site Status

Ohio Health Research Institute

Columbus, Ohio, United States

Site Status

Allegheny Singer Research Institute

Pittsburgh, Pennsylvania, United States

Site Status

Berks Cardiologists

Wyomissing, Pennsylvania, United States

Site Status

University of Virginia

Charlottesville, Virginia, United States

Site Status

Cardiac Study Center

Puyallup, Washington, United States

Site Status

St. Vincent's Hospital

Darlinghurst, New South Wales, Australia

Site Status

Royal North Shore Hospital

St Leonards, New South Wales, Australia

Site Status

The Prince Charles Hospital

Chermside, Queensland, Australia

Site Status

Greenslopes Private Hospital

Greenslopes, Queensland, Australia

Site Status

Monash Heart

Clayton, Victoria, Australia

Site Status

Alfred Hospital

Melbourne, Victoria, Australia

Site Status

The University of British Columbia

Vancouver, British Columbia, Canada

Site Status

Poliklinika Sunce

Zagreb, , Croatia

Site Status

University of Erlangen

Erlangen, , Germany

Site Status

Isar Heart Center

Munich, , Germany

Site Status

Semmelweis University

Budapest, , Hungary

Site Status

University of Kaposvar

Kaposvár, , Hungary

Site Status

Meander Medical Center

Amersfoot, , Netherlands

Site Status

Canisius Wilhelmina Ziekenhuis

Nijmegen, , Netherlands

Site Status

Institute of Cardiology

Warsaw, , Poland

Site Status

Ulster Hospital

Belfast, , United Kingdom

Site Status

Liverpool Heart and Chest Hospital

Liverpool, , United Kingdom

Site Status

Royal Liverpool University Hospital

Liverpool, , United Kingdom

Site Status

Plymouth Hospitals NHS Trust of Derriford Hospital

Plymouth, , United Kingdom

Site Status

Countries

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United States Australia Canada Croatia Germany Hungary Netherlands Poland United Kingdom

References

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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.

Reference Type DERIVED
PMID: 35290075 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33392384 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25439791 (View on PubMed)

Other Identifiers

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CR0001

Identifier Type: -

Identifier Source: org_study_id

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