Trial Review

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01738828




Registration number
NCT01738828
Ethics application status
Date submitted
28/11/2012
Date registered
30/11/2012
Date last updated
9/02/2016

Titles & IDs
Public title
GLOBAL Clinical Study
Scientific title
Genetic Loci and the Burden of Atherosclerotic Lesions
Secondary ID [1] 0 0
CR0001
Universal Trial Number (UTN)
Trial acronym
GLOBAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Subjects with CAD -

Subjects without CAD -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Genome-Wide Association
Timepoint [1] 0 0
Baseline

Eligibility
Key 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
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2016
Actual
Sample size
Target
10000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
St. Vincent's Hospital - Darlinghurst
Recruitment hospital [2] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment hospital [3] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [4] 0 0
Greenslopes Private Hospital - Greenslopes
Recruitment hospital [5] 0 0
Monash Heart - Clayton
Recruitment hospital [6] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Darlinghurst
Recruitment postcode(s) [2] 0 0
- St. Leonards
Recruitment postcode(s) [3] 0 0
- Chermside
Recruitment postcode(s) [4] 0 0
- Greenslopes
Recruitment postcode(s) [5] 0 0
- Clayton
Recruitment postcode(s) [6] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Minnesota
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
Virginia
Country [19] 0 0
United States of America
State/province [19] 0 0
Washington
Country [20] 0 0
Canada
State/province [20] 0 0
British Columbia
Country [21] 0 0
Croatia
State/province [21] 0 0
Zagreb
Country [22] 0 0
Germany
State/province [22] 0 0
Erlangen
Country [23] 0 0
Germany
State/province [23] 0 0
Munich
Country [24] 0 0
Hungary
State/province [24] 0 0
Budapest
Country [25] 0 0
Hungary
State/province [25] 0 0
Kaposvar
Country [26] 0 0
Netherlands
State/province [26] 0 0
Amersfoot
Country [27] 0 0
Netherlands
State/province [27] 0 0
Nijmegen
Country [28] 0 0
Poland
State/province [28] 0 0
Warsaw
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Belfast
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Liverpool
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Plymouth

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Global Genomics Group, LLC
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01738828
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Szilard Voros, MD
Address 0 0
Global Genomics Group, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01738828