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GLOBAL Clinical Study (GLOBAL)

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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

Study Description
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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.


Condition or disease
Coronary Artery Disease

Study Design
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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Genetic Loci and the Burden of Atherosclerotic Lesions
Study Start Date : December 2012
Actual Primary Completion Date : May 2014
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Subjects with CAD
Subjects without CAD


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
Whole blood, serum, plasma, buffy coat and RNA PAXgene

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01738828


Locations
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Sponsors and Collaborators
Global Genomics Group, LLC
Investigators
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Study Director: Szilard Voros, MD Global Genomics Group, LLC
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Global Genomics Group, LLC
ClinicalTrials.gov Identifier: NCT01738828    
Other Study ID Numbers: CR0001
First Posted: November 30, 2012    Key Record Dates
Last Update Posted: February 9, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases