The GLOBAL Study (Genetic Loci and the Burden of Atherosclerotic Lesions) Protocol# CR0001

Recruiting

Conditions: coronary artery disease heart disease
10011082

Registration Number: NL-OMON38542

Lead Sponsor: Biotechnologische Industrie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 600

Inclusion Criteria

1. Ages 18-90
2. White 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

General 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 non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of this study is to understand novel genomic associations<br /><br>of CAD by using advanced cardiovascular imaging for CAD phenotyping and<br /><br>next-generation whole genome genotyping and sequencing.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>A secondary objective of this study is to understand novel gene expression,<br /><br>metabolomic, lipidomic and proteomic associations of CAD by using advanced<br /><br>cardiovascular imaging and state-of-the-art biomarker approaches.</p><br>