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Trial record 1 of 1 for:    NCT01738828
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GLOBAL Clinical Study (GLOBAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01738828
Recruitment Status : Unknown
Verified February 2016 by Global Genomics Group, LLC.
Recruitment status was:  Active, not recruiting
First Posted : November 30, 2012
Last Update Posted : February 9, 2016
Sponsor:
Information provided by (Responsible Party):
Global Genomics Group, LLC

Tracking Information
First Submitted Date November 28, 2012
First Posted Date November 30, 2012
Last Update Posted Date February 9, 2016
Study Start Date December 2012
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 28, 2012)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title GLOBAL Clinical Study
Official Title Genetic Loci and the Burden of Atherosclerotic Lesions
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 Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood, serum, plasma, buffy coat and RNA PAXgene
Sampling Method Probability Sample
Study Population Patients presenting for clinically indicated coronary CT angiography for an assessment of possible CAD are potential study candidates.
Condition Coronary Artery Disease
Intervention Not Provided
Study Groups/Cohorts
  • Subjects with CAD
  • Subjects without CAD
Publications * Voros S, Maurovich-Horvat P, Marvasty IB, Bansal AT, Barnes MR, Vazquez G, Murray SS, Voros V, Merkely B, Brown BO, Warnick GR. Precision phenotyping, panomics, and system-level bioinformatics to delineate complex biologies of atherosclerosis: rationale and design of the "Genetic Loci and the Burden of Atherosclerotic Lesions" study. J Cardiovasc Comput Tomogr. 2014 Nov-Dec;8(6):442-51. doi: 10.1016/j.jcct.2014.08.006. Epub 2014 Sep 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: November 28, 2012)
10000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2016
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia,   Canada,   Croatia,   Germany,   Hungary,   Netherlands,   Poland,   United Kingdom,   United States
Removed Location Countries Ireland
 
Administrative Information
NCT Number NCT01738828
Other Study ID Numbers CR0001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Global Genomics Group, LLC
Study Sponsor Global Genomics Group, LLC
Collaborators Not Provided
Investigators
Study Director: Szilard Voros, MD Global Genomics Group, LLC
PRS Account Global Genomics Group, LLC
Verification Date February 2016