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GLOBAL Clinical Study

Genetic Loci and the Burden of Atherosclerotic Lesions

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01738828
Acronym
GLOBAL
Enrollment
10000
Registered
2012-11-30
Start date
2012-12-31
Completion date
2016-12-31
Last updated
2016-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

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.

Interventions

None listed

Sponsors

Global Genomics Group, LLC
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Genome-Wide AssociationBaselineThe primary analysis will be a genome-wide association analysis, to determine candidate genes and markers underlying coronary artery disease.

Countries

Australia, Canada, Croatia, Germany, Hungary, Netherlands, Poland, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026