GLOBAL Clinical Study
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT01738828
- Lead Sponsor
- Global Genomics Group, LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 10000
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Genome-Wide Association Baseline The primary analysis will be a genome-wide association analysis, to determine candidate genes and markers underlying coronary artery disease.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (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, 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
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