GLOBAL Clinical Study

Coronary Artery Disease Clinical Trial

— GLOBAL  

Official title:

Genetic Loci and the Burden of Atherosclerotic Lesions

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01738828
• Other study ID #: CR0001
• 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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

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