NCT02126150

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 29, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 8, 2015

Status Verified

December 1, 2015

Enrollment Period

5.3 years

First QC Date

April 24, 2014

Last Update Submit

December 7, 2015

Conditions

Coronary Artery DiseaseAcute Coronary SyndromeMyocardial InfarctionStable Angina

Outcome Measures

Primary Outcomes (1)

  • All-cause death

    5 years

Secondary Outcomes (1)

  • Major cardiovascular events

    5 years

Study Arms (1)

Ethnicity

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patients undergoing coronary angiography

You may not qualify if:

  • \< 21 years of age
  • Hemoglobin levels \<7 g/dL in women, or hemoglobin levels \<8 g/dL in men

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Singapore, Singapore, 119074, Singapore

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Coronary Artery DiseaseAcute Coronary SyndromeMyocardial InfarctionAngina, Stable

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisAngina PectorisChest PainPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 24, 2014

First Posted

April 29, 2014

Study Start

September 1, 2010

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 8, 2015

Record last verified: 2015-12

Locations

SG(1)