Coronary Artery DiseaseUNICORNNCT02126150
United Coronary Biobanks
An observational study of Coronary Artery Disease and Acute Coronary Syndrome, run by UMC Utrecht at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Coronary Artery Disease, Acute Coronary Syndrome, Myocardial Infarction
- How many people
- 2,000 participants
- Where
- 1 siteSingapore
- Study dates
- Sep 2010to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients that undergo coronary catheterization for any reason are eligible to enroll in the study.
Who may be able to join
- Patients undergoing coronary angiography
Who cannot join
- < 21 years of age
- Hemoglobin levels <7 g/dL in women, or hemoglobin levels <8 g/dL in men
Trial locations and contacts
1 site in 1 country.
About this study
Official title: United CORoNary Biobanks
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.
Read more
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.
- Medical subject headings
- Coronary Artery Disease, Acute Coronary Syndrome, Myocardial Infarction, Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ethnicity | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause death
Measured: 5 years
Secondary outcomes (1)
Major cardiovascular events
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study startSep 2010
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- National University Hospital, Singapore
- Responsible party
- Principal investigator, Crystel Gijsberts, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02126150
- Sponsor's protocol ID
- 11-183
- Acronym
- UNICORN
- Status last verified
- Dec 2015
- First submitted
- 24 Apr 2014
- Last updated
- 8 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- United CORoNary Biobanks
- ClinicalTrials.gov ID
- NCT02126150
- Acronym / sponsor ID
- UNICORN / 11-183
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- National University Hospital, Singapore
- Study start
- Sep 2010
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 29 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ethnicity | – | – |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients that undergo coronary catheterization for any reason are eligible to enroll in the study.
Key inclusion criteria (1 listed)
- Patients undergoing coronary angiography
Key exclusion criteria (2 listed)
- < 21 years of age
- Hemoglobin levels <7 g/dL in women, or hemoglobin levels <8 g/dL in men
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause death
Time frame: 5 years
1 secondary outcome
Major cardiovascular events
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2015.
Related trials for Coronary Artery Disease
Active, not recruiting
Comparison of Vessel-FFR Versus FFR in Intermediate Coronary Stenoses
Coronary Artery Disease, Coronary Artery Stenoses
Recruiting
Lifewise Preventive Video Education in Primary Care
Prevention Harmful Effects, Health Maintenance
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Recruiting
Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina
Stable Angina, Multivessel Coronary Artery Disease
RecruitingObservational study
Cardiovascular Acoustics for Early Disease Detection
Valvular Heart Disease, Coronary Artery Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Acute Coronary Syndrome, run by UMC Utrecht at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause death (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2015; AzTrials last refreshed its copy on 30 Oct 2026.