Coronary Artery DiseaseUCORBIONCT02304744
Utrecht Coronary Biobank (UCORBIO)
An observational study of Coronary Artery Disease, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
UCORBIO enrolls patients who undergo coronary angiography (for any indication). The investigators draw blood at the moment of insertion of the procedural arterial catheter. At the moment of inclusion indication, procedural details, risk factor status, medication use and quality of life (RAND-36 and EuroQoL) is… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 3,000 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2011to Dec 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult (>18 years) patients who undergo coronary angiography.
Who may be able to join
- Coronary angiography
Who cannot join
- Age < 18 years.
Trial locations and contacts
1 site in 1 country.
About this study
UCORBIO enrolls patients who undergo coronary angiography (for any indication). The investigators draw blood at the moment of insertion of the procedural arterial catheter.
At the moment of inclusion indication, procedural details, risk factor status, medication use and quality of life (RAND-36 and EuroQoL) is assessed. Patients are then followed-up for the occurrence of major adverse cardiovascular events for 5 years. During the follow-up period patients receive a questionnaire every year to check for hospital admissions. The questionnaires at two and five years of follow-up are enriched with quality of life questionnaires (RAND-36 and EuroQoL).
- Conditions
- Coronary Artery Disease
- Being tested
- Observational study, no intervention.
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study, no intervention.Other
Observational study, no intervention.
What is being measured
The primary outcome is the main question the study is designed to answer.
major adverse cardiovascular events [MACE] (Stroke, myocardial infarction, coronary revascularization, death)
Stroke, myocardial infarction, coronary revascularization, death.
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 posted2 Dec 2014 (estimated)
- Study startOct 2011
- Primary completionDec 2014
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- 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
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Crystel Gijsberts, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02304744
- Sponsor's protocol ID
- 11/183
- Acronym
- UCORBIO
- Status last verified
- Mar 2015
- First submitted
- 26 Nov 2014
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Gijsberts CM, Santema BT, Asselbergs FW, de Kleijn DP, Voskuil M, Agostoni P, Cramer MJ, Vaartjes I, Hoefer IE, Pasterkamp G, den Ruijter HM. Women Undergoing Coronary Angiography for Myocardial Infarction or Who Present With Multivessel Disease Have a Poorer Prognosis Than Men. Angiology. 2016 Jul;67(6):571-81. doi: 10.1177/0003319715604762. Epub 2015 Sep 7.
PubMed 26351289Gijsberts CM, Agostoni P, Hoefer IE, Asselbergs FW, Pasterkamp G, Nathoe H, Appelman YE, de Kleijn DP, den Ruijter HM. Gender differences in health-related quality of life in patients undergoing coronary angiography. Open Heart. 2015 Aug 27;2(1):e000231. doi: 10.1136/openhrt-2014-000231. eCollection 2015.
PubMed 26339493Gijsberts CM, Gohar A, Ellenbroek GH, Hoefer IE, de Kleijn DP, Asselbergs FW, Nathoe HM, Agostoni P, Rittersma SZ, Pasterkamp G, Appelman Y, den Ruijter HM. Severity of stable coronary artery disease and its biomarkers differ between men and women undergoing angiography. Atherosclerosis. 2015 Jul;241(1):234-40. doi: 10.1016/j.atherosclerosis.2015.02.002. Epub 2015 Feb 4.
PubMed 25670231
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utrecht Coronary Biobank (UCORBIO)
- ClinicalTrials.gov ID
- NCT02304744
- Acronym / sponsor ID
- UCORBIO / 11/183
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2019 (estimated)
- First posted
- 2 Dec 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.
UCORBIO enrolls patients who undergo coronary angiography (for any indication). The investigators draw blood at the moment of insertion of the procedural arterial catheter.
At the moment of inclusion indication, procedural details, risk factor status, medication use and quality of life (RAND-36 and EuroQoL) is assessed. Patients are then followed-up for the occurrence of major adverse cardiovascular events for 5 years. During the follow-up period patients receive a questionnaire every year to check for hospital admissions. The questionnaires at two and five years of follow-up are enriched with quality of life questionnaires (RAND-36 and EuroQoL).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult (>18 years) patients who undergo coronary angiography.
Key inclusion criteria (1 listed)
- Coronary angiography
Key exclusion criteria (1 listed)
- Age < 18 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational study, no intervention.Observational study, no intervention. | Other | – |
Primary outcome
major adverse cardiovascular events [MACE] (Stroke, myocardial infarction, coronary revascularization, death)
Time frame: 5 years
Stroke, myocardial infarction, coronary revascularization, death.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
- Derived from this study: PubMed 26351289Gijsberts CM, Santema BT, Asselbergs FW, de Kleijn DP, Voskuil M, Agostoni P, Cramer MJ, Vaartjes I, Hoefer IE, Pasterkamp G, den Ruijter HM. Women Undergoing Coronary Angiography for Myocardial Infarction or Who Present With Multivessel Disease Have a Poorer Prognosis Than Men. Angiology. 2016 Jul;67(6):571-81. doi: 10.1177/0003319715604762. Epub 2015 Sep 7.
- Derived from this study: PubMed 26339493Gijsberts CM, Agostoni P, Hoefer IE, Asselbergs FW, Pasterkamp G, Nathoe H, Appelman YE, de Kleijn DP, den Ruijter HM. Gender differences in health-related quality of life in patients undergoing coronary angiography. Open Heart. 2015 Aug 27;2(1):e000231. doi: 10.1136/openhrt-2014-000231. eCollection 2015.
- Derived from this study: PubMed 25670231Gijsberts CM, Gohar A, Ellenbroek GH, Hoefer IE, de Kleijn DP, Asselbergs FW, Nathoe HM, Agostoni P, Rittersma SZ, Pasterkamp G, Appelman Y, den Ruijter HM. Severity of stable coronary artery disease and its biomarkers differ between men and women undergoing angiography. Atherosclerosis. 2015 Jul;241(1):234-40. doi: 10.1016/j.atherosclerosis.2015.02.002. Epub 2015 Feb 4.
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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, run by UMC Utrecht at 1 site in Netherlands.
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 1 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: status not confirmed, as of the sponsor's last update on 6 Mar 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 Netherlands. 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?
Results are not available in the source record.
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?
major adverse cardiovascular events [MACE] (Stroke, myocardial infarction, coronary revascularization, 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?
On the ClinicalTrials.gov record for NCT02304744, which also lists 3 linked publications.
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 6 Mar 2015.