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

Study Timeline

• Study First Submitted: 2012-11-28
• Study First Submitted QC: 2012-11-28
• Study First Posted: 2012-11-30
• Study Start: 2012-12
• Primary Completion: 2014-05
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-08
• Last Update Posted: 2016-02-09
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10000

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

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.

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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