GLOBAL Clinical Study
This study is currently recruiting participants.
Verified December 2012 by Global Genomics Group, LLC
Sponsor:
Global Genomics Group, LLC
Information provided by (Responsible Party):
Global Genomics Group, LLC
ClinicalTrials.gov Identifier:
NCT01738828
First received: November 28, 2012
Last updated: December 31, 2012
Last verified: December 2012
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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: | July 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:
- Ages 18-90
- Caucasian and of Non-Hispanic or Non-Latino origin
- Referral for coronary CT angiography to evaluate for presence of CAD
- The patient has signed the appropriate Institutional Review Board approved Informed Consent Form
Exclusion Criteria:
- 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).
- Chemotherapy in the preceding year
- Major surgery in the preceding 2 months
- Blood or blood product transfusion in the preceding 2 months
- Subjects for whom coronary CT angiography is contraindicated per institutional standard of care
- Subjects with previous coronary arterial revascularization (PCI or CABG)
- Subjects with atrial fibrillation/flutter or frequent irregular or rapid heart rhythms, which occurred within the past 3 months
- Subjects with a pacemaker or implantable cardioverter-defibrillator implant
- Active congestive heart failure or the presence of known non-ischemic cardiomyopathy
- 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 |
Locations
| United States, Kansas | |
| Midwest Cardiology Associates | Recruiting |
| Overland Park, Kansas, United States, 66209 | |
| Hungary | |
| Semmelweis University | Not yet recruiting |
| Budapest, Hungary | |
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: | December 31, 2012 |
| 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 May 16, 2013