GLOBAL Clinical Study (GLOBAL)

February 8, 2016 updated by: Global Genomics Group, LLC

Genetic Loci and the Burden of Atherosclerotic Lesions

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients presenting for clinically indicated coronary CT angiography for an assessment of possible CAD are potential study candidates.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Subjects with CAD
Subjects without CAD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genome-Wide Association
Time Frame: Baseline
The primary analysis will be a genome-wide association analysis, to determine candidate genes and markers underlying coronary artery disease.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Global Genomics Group, LLC

Investigators

  • Study Director: Szilard Voros, MD, Global Genomics Group, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

May 1, 2014

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

November 28, 2012

First Submitted That Met QC Criteria

November 28, 2012

First Posted (Estimate)

November 30, 2012

Study Record Updates

Last Update Posted (Estimate)

February 9, 2016

Last Update Submitted That Met QC Criteria

February 8, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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