MedPath

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
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
NameTimeMethod
Genome-Wide AssociationBaseline

The primary analysis will be a genome-wide association analysis, to determine candidate genes and markers underlying coronary artery disease.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (48)

Zwanger Pesiri Radiology

๐Ÿ‡บ๐Ÿ‡ธ

Stony Brook, New York, United States

Cardiac Study Center

๐Ÿ‡บ๐Ÿ‡ธ

Puyallup, Washington, United States

William Beaumont Hospital

๐Ÿ‡บ๐Ÿ‡ธ

Royal Oak, Michigan, United States

Ohio Health Research Institute

๐Ÿ‡บ๐Ÿ‡ธ

Columbus, Ohio, United States

Allegheny Singer Research Institute

๐Ÿ‡บ๐Ÿ‡ธ

Pittsburgh, Pennsylvania, United States

University of Chicago

๐Ÿ‡บ๐Ÿ‡ธ

Chicago, Illinois, United States

Minneapolis Heart Institute Foundation

๐Ÿ‡บ๐Ÿ‡ธ

Minneapolis, Minnesota, United States

University of Minnesota

๐Ÿ‡บ๐Ÿ‡ธ

Minneapolis, Minnesota, United States

Sentral Clinical Research Services

๐Ÿ‡บ๐Ÿ‡ธ

Cincinnati, Ohio, United States

The Linder Center for Research & Education at The Christ Hospital

๐Ÿ‡บ๐Ÿ‡ธ

Cincinnati, Ohio, United States

University of Cincinnati Physicians Company

๐Ÿ‡บ๐Ÿ‡ธ

Cincinnati, Ohio, United States

Heart Center Research

๐Ÿ‡บ๐Ÿ‡ธ

Huntsville, Alabama, United States

Sutter Roseville Medical Center

๐Ÿ‡บ๐Ÿ‡ธ

Roseville, California, United States

Georgia Regents University

๐Ÿ‡บ๐Ÿ‡ธ

Augusta, Georgia, United States

Poliklinika Sunce

๐Ÿ‡ญ๐Ÿ‡ท

Zagreb, Croatia

The University of Arizona

๐Ÿ‡บ๐Ÿ‡ธ

Tucson, Arizona, United States

Colorado Health Medical Group

๐Ÿ‡บ๐Ÿ‡ธ

Colorado Springs, Colorado, United States

University of Virginia

๐Ÿ‡บ๐Ÿ‡ธ

Charlottesville, Virginia, United States

Baton Rouge General Medical Center

๐Ÿ‡บ๐Ÿ‡ธ

Baton Rouge, Louisiana, United States

United Heart and Vascular Center

๐Ÿ‡บ๐Ÿ‡ธ

St. Paul, Minnesota, United States

Iowa Heart Center

๐Ÿ‡บ๐Ÿ‡ธ

West Des Moines, Iowa, United States

Liverpool Heart and Chest Hospital

๐Ÿ‡ฌ๐Ÿ‡ง

Liverpool, United Kingdom

Berks Cardiologists

๐Ÿ‡บ๐Ÿ‡ธ

Wyomissing, Pennsylvania, United States

Greenslopes Private Hospital

๐Ÿ‡ฆ๐Ÿ‡บ

Greenslopes, Queensland, Australia

Alfred Hospital

๐Ÿ‡ฆ๐Ÿ‡บ

Melbourne, Victoria, Australia

Royal North Shore Hospital

๐Ÿ‡ฆ๐Ÿ‡บ

St. Leonards, New South Wales, Australia

The MedStar Heart Research Institute

๐Ÿ‡บ๐Ÿ‡ธ

Washington, District of Columbia, United States

Elite Research and Clinical Trials

๐Ÿ‡บ๐Ÿ‡ธ

Miami Beach, Florida, United States

Long Island Heart Associates

๐Ÿ‡บ๐Ÿ‡ธ

Mineloa, New York, United States

Meander Medical Center

๐Ÿ‡ณ๐Ÿ‡ฑ

Amersfoot, Netherlands

Detroit Clinical Research Center

๐Ÿ‡บ๐Ÿ‡ธ

Farmington Hills, Michigan, United States

Walter Reed National Military Medical Center

๐Ÿ‡บ๐Ÿ‡ธ

Bethesda, Maryland, United States

Isar Heart Center

๐Ÿ‡ฉ๐Ÿ‡ช

Munich, Germany

Canisius Wilhelmina Ziekenhuis

๐Ÿ‡ณ๐Ÿ‡ฑ

Nijmegen, Netherlands

Institute of Cardiology

๐Ÿ‡ต๐Ÿ‡ฑ

Warsaw, Poland

Plymouth Hospitals NHS Trust of Derriford Hospital

๐Ÿ‡ฌ๐Ÿ‡ง

Plymouth, United Kingdom

Semmelweis University

๐Ÿ‡ญ๐Ÿ‡บ

Budapest, Hungary

University of Erlangen

๐Ÿ‡ฉ๐Ÿ‡ช

Erlangen, Germany

University of Kaposvar

๐Ÿ‡ญ๐Ÿ‡บ

Kaposvar, Hungary

Ulster Hospital

๐Ÿ‡ฌ๐Ÿ‡ง

Belfast, United Kingdom

Monash Heart

๐Ÿ‡ฆ๐Ÿ‡บ

Clayton, Victoria, Australia

Saint Luke's Lipid and Diabetes Research Center

๐Ÿ‡บ๐Ÿ‡ธ

Kansas City, Missouri, United States

The Prince Charles Hospital

๐Ÿ‡ฆ๐Ÿ‡บ

Chermside, Queensland, Australia

St. Francis Hospital

๐Ÿ‡บ๐Ÿ‡ธ

Roslyn, New York, United States

Midwest Heart and Vascular Specialists

๐Ÿ‡บ๐Ÿ‡ธ

Kansas City, Missouri, United States

St. Vincent's Hospital

๐Ÿ‡ฆ๐Ÿ‡บ

Darlinghurst, New South Wales, Australia

The University of British Columbia

๐Ÿ‡จ๐Ÿ‡ฆ

Vancouver, British Columbia, Canada

Royal Liverpool University Hospital

๐Ÿ‡ฌ๐Ÿ‡ง

Liverpool, United Kingdom

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