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United Coronary Biobanks (UNICORN)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by UMC Utrecht
Sponsor:
Collaborator:
National University Hospital, Singapore
Information provided by (Responsible Party):
Crystel Gijsberts, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT02126150
First received: April 24, 2014
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

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.


Condition
Coronary Artery Disease
Acute Coronary Syndrome
Myocardial Infarction
Stable Angina

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: United CORoNary Biobanks

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • All-cause death [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Major cardiovascular events [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Plasma, peripheral blood mononuclear cells and whole blood is stored.


Estimated Enrollment: 8000
Study Start Date: September 2010
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients that undergo coronary catheterization for any reason are eligible to enroll in the study.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02126150

Contacts
Contact: Dominique PV de Kleijn, PhD +65 97120912 surdvp@nus.edu.sg

Locations
Singapore
National University Hospital Recruiting
Singapore, Singapore, 119074
Contact: Mark YY Chan, MD    +65 6772 5596    mark_chan@nuhs.edu.sg   
Sponsors and Collaborators
UMC Utrecht
National University Hospital, Singapore
  More Information

No publications provided

Responsible Party: Crystel Gijsberts, MD, UMC Utrecht
ClinicalTrials.gov Identifier: NCT02126150     History of Changes
Other Study ID Numbers: 11-183
Study First Received: April 24, 2014
Last Updated: April 28, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Additional relevant MeSH terms:
Acute Coronary Syndrome
Angina, Stable
Coronary Artery Disease
Coronary Disease
Infarction
Myocardial Infarction
Myocardial Ischemia
Angina Pectoris
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Chest Pain
Heart Diseases
Ischemia
Necrosis
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014