GLOBAL Clinical Study

This study is currently recruiting participants.
Verified February 2014 by Global Genomics Group, LLC
Sponsor:
Information provided by (Responsible Party):
Global Genomics Group, LLC
ClinicalTrials.gov Identifier:
NCT01738828
First received: November 28, 2012
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

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.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Genetic Loci and the Burden of Atherosclerotic Lesions

Resource links provided by NLM:


Further study details as provided by Global Genomics Group, LLC:

Primary Outcome Measures:
  • Genome-Wide Association [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The primary analysis will be a genome-wide association analysis, to determine candidate genes and markers underlying coronary artery disease.


Biospecimen Retention:   Samples With DNA

Whole blood, serum, plasma, buffy coat and RNA PAXgene


Estimated Enrollment: 10000
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Subjects with CAD
Subjects without CAD

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01738828

Contacts
Contact: Brad Brown, MS (804) 638-8598 brad.brown@globalgenomicsgroup.com
Contact: Jeremy Moyer, MS (610) 509-6727 jeremy.moyer@globalgenomicsgroup.com

  Show 48 Study Locations
Sponsors and Collaborators
Global Genomics Group, LLC
Investigators
Study Director: Szilard Voros, MD Global Genomics Group, LLC
  More Information

No publications provided

Responsible Party: Global Genomics Group, LLC
ClinicalTrials.gov Identifier: NCT01738828     History of Changes
Other Study ID Numbers: CR0001
Study First Received: November 28, 2012
Last Updated: February 12, 2014
Health Authority: United States: Institutional Review Board
Hungary: Institutional Ethics Committee
United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 14, 2014