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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01738828
Other study ID # CR0001
Secondary ID
Status Active, not recruiting
Phase N/A
First received November 28, 2012
Last updated February 8, 2016
Start date December 2012
Est. completion date December 2016

Study information

Verified date February 2016
Source Global Genomics Group, LLC
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardHungary: Institutional Ethics CommitteeUnited Kingdom: Research Ethics Committee
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 10000
Est. completion date December 2016
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility 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

Observational Model: Case Control, Time Perspective: Prospective


Locations

Country Name City State
Australia The Prince Charles Hospital Chermside Queensland
Australia Monash Heart Clayton Victoria
Australia St. Vincent's Hospital Darlinghurst New South Wales
Australia Greenslopes Private Hospital Greenslopes Queensland
Australia Alfred Hospital Melbourne Victoria
Australia Royal North Shore Hospital St. Leonards New South Wales
Canada The University of British Columbia Vancouver British Columbia
Croatia Poliklinika Sunce Zagreb
Germany University of Erlangen Erlangen
Germany Isar Heart Center Munich
Hungary Semmelweis University Budapest
Hungary University of Kaposvar Kaposvar
Netherlands Meander Medical Center Amersfoot
Netherlands Canisius Wilhelmina Ziekenhuis Nijmegen
Poland Institute of Cardiology Warsaw
United Kingdom Ulster Hospital Belfast
United Kingdom Liverpool Heart and Chest Hospital Liverpool
United Kingdom Royal Liverpool University Hospital Liverpool
United Kingdom Plymouth Hospitals NHS Trust of Derriford Hospital Plymouth
United States Georgia Regents University Augusta Georgia
United States Baton Rouge General Medical Center Baton Rouge Louisiana
United States Walter Reed National Military Medical Center Bethesda Maryland
United States University of Virginia Charlottesville Virginia
United States University of Chicago Chicago Illinois
United States Sentral Clinical Research Services Cincinnati Ohio
United States The Linder Center for Research & Education at The Christ Hospital Cincinnati Ohio
United States University of Cincinnati Physicians Company Cincinnati Ohio
United States Colorado Health Medical Group Colorado Springs Colorado
United States Ohio Health Research Institute Columbus Ohio
United States Detroit Clinical Research Center Farmington Hills Michigan
United States Heart Center Research Huntsville Alabama
United States Midwest Heart and Vascular Specialists Kansas City Missouri
United States Saint Luke's Lipid and Diabetes Research Center Kansas City Missouri
United States Elite Research and Clinical Trials Miami Beach Florida
United States Long Island Heart Associates Mineloa New York
United States Minneapolis Heart Institute Foundation Minneapolis Minnesota
United States University of Minnesota Minneapolis Minnesota
United States Allegheny Singer Research Institute Pittsburgh Pennsylvania
United States Cardiac Study Center Puyallup Washington
United States Sutter Roseville Medical Center Roseville California
United States St. Francis Hospital Roslyn New York
United States William Beaumont Hospital Royal Oak Michigan
United States United Heart and Vascular Center St. Paul Minnesota
United States Zwanger Pesiri Radiology Stony Brook New York
United States The University of Arizona Tucson Arizona
United States The MedStar Heart Research Institute Washington District of Columbia
United States Iowa Heart Center West Des Moines Iowa
United States Berks Cardiologists Wyomissing Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Global Genomics Group, LLC

Countries where clinical trial is conducted

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

Outcome

Type Measure Description Time frame Safety issue
Primary Genome-Wide Association The primary analysis will be a genome-wide association analysis, to determine candidate genes and markers underlying coronary artery disease. Baseline No
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