Clinical trial NCT01738828: GLOBAL Clinical Study
Official title: Genetic Loci and the Burden of Atherosclerotic Lesions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Lead sponsor: Global Genomics Group, LLC
Sponsor class: INDUSTRY
First posted: 2012-11-30
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients presenting for clinically indicated coronary CT angiography for an assessment of possible CAD are potential study candidates.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Genome-Wide Association
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Heart Center Research
state: Alabama
city: Tucson
country: United States
facility: The University of Arizona
state: Arizona
city: Roseville
country: United States
facility: Sutter Roseville Medical Center
state: California
city: Colorado Springs
country: United States
facility: Colorado Health Medical Group
state: Colorado
city: Washington
country: United States
facility: The MedStar Heart Research Institute
state: District of Columbia
city: Miami Beach
country: United States
facility: Elite Research and Clinical Trials
state: Florida
city: Augusta
country: United States
facility: Georgia Regents University
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: West Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Baton Rouge
country: United States
facility: Baton Rouge General Medical Center
state: Louisiana
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Farmington Hills
country: United States
facility: Detroit Clinical Research Center
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: St. Paul
country: United States
facility: United Heart and Vascular Center
state: Minnesota
city: Kansas City
country: United States
facility: Midwest Heart and Vascular Specialists
state: Missouri
city: Kansas City
country: United States
facility: Saint Luke's Lipid and Diabetes Research Center
state: Missouri
city: Mineloa
country: United States
facility: Long Island Heart Associates
state: New York
city: Roslyn
country: United States
facility: St. Francis Hospital
state: New York
city: Stony Brook
country: United States
facility: Zwanger Pesiri Radiology
state: New York
city: Cincinnati
country: United States
facility: Sentral Clinical Research Services
state: Ohio
city: Cincinnati
country: United States
facility: The Linder Center for Research & Education at The Christ Hospital
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati Physicians Company
state: Ohio
city: Columbus
country: United States
facility: Ohio Health Research Institute
state: Ohio
city: Pittsburgh
country: United States
facility: Allegheny Singer Research Institute
state: Pennsylvania
city: Wyomissing
country: United States
facility: Berks Cardiologists
state: Pennsylvania
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Puyallup
country: United States
facility: Cardiac Study Center
state: Washington
city: Darlinghurst
country: Australia
facility: St. Vincent's Hospital
state: New South Wales
city: St. Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Chermside
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: Greenslopes
country: Australia
facility: Greenslopes Private Hospital
state: Queensland
city: Clayton
country: Australia
facility: Monash Heart
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Vancouver
country: Canada
facility: The University of British Columbia
state: British Columbia
city: Zagreb
country: Croatia
facility: Poliklinika Sunce
city: Erlangen
country: Germany
facility: University of Erlangen
city: Munich
country: Germany
facility: Isar Heart Center
city: Budapest
country: Hungary
facility: Semmelweis University
city: Kaposvar
country: Hungary
facility: University of Kaposvar
city: Amersfoot
country: Netherlands
facility: Meander Medical Center
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina Ziekenhuis
city: Warsaw
country: Poland
facility: Institute of Cardiology
city: Belfast
country: United Kingdom
facility: Ulster Hospital
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
city: Plymouth
country: United Kingdom
facility: Plymouth Hospitals NHS Trust of Derriford Hospital
Study officials:
affiliation: Global Genomics Group, LLC
name: Szilard Voros, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.