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NCT02126150 Clinical Trial

United Coronary Biobanks

Coronary Artery Disease Clinical Trial

— UNICORN  

Official title:
United CORoNary Biobanks

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02126150
Other study ID # 11-183
Secondary ID
Status Completed
Phase N/A
First received April 24, 2014
Last updated December 7, 2015
Start date September 2010
Est. completion date December 2015

Study information
Verified date December 2015
Source UMC Utrecht
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Observational

Clinical Trial Summary

The UNICORN consists of two collaborating biobanks, one in Utrecht and one in Singapore. From these two sites we include all patients who undergo a coronary catheterization for any reason.

At the moment of catheterization we draw blood, which will be stored in a biobank and we collect clinical characteristics. Patients are followed-up for 5 years for the occurrence of major cardiovascular events.

By including from two sites in the world we include 4 major ethnic groups: Caucasians, Chinese, Indians and Malays. We aim at including at least 2000 patients per ethnic group.

Our hypothesis is that there are differences in the risk factor burden, clinical presentation of CAD, and biochemical patterns in the blood among the ethnic groups.

Furthermore, this biobank offers a platform for multi-ethnic biomarker discovery.

Recruitment information / eligibility
Status Completed
Enrollment 2000
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 21 Years and older
Eligibility Inclusion Criteria:

- Patients undergoing coronary angiography

Exclusion Criteria:

- < 21 years of age

- Hemoglobin levels <7 g/dL in women, or hemoglobin levels <8 g/dL in men

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Singapore National University Hospital Singapore

Sponsors (2)
Lead Sponsor Collaborator
UMC Utrecht National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome
Type Measure Description Time frame Safety issue
Primary All-cause death 5 years No
Secondary Major cardiovascular events 5 years No
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