NCT02304744

Brief 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 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).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2011

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

November 26, 2014

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2014

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 6, 2015

Status Verified

March 1, 2015

Enrollment Period

3.2 years

First QC Date

November 26, 2014

Last Update Submit

March 5, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • major adverse cardiovascular events [MACE] (Stroke, myocardial infarction, coronary revascularization, death)

    Stroke, myocardial infarction, coronary revascularization, death.

    5 years

Interventions

Observational study, no intervention.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adult (\>18 years) patients who undergo coronary angiography.

You may qualify if:

  • Coronary angiography

You may not qualify if:

  • Age \< 18 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMC Utrecht

Utrecht, Utrecht, 3508GA, Netherlands

Location

Related Publications (3)

  • 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.

  • Gijsberts 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.

  • Gijsberts 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.

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and EDTA plasma.

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Observation

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

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

November 26, 2014

First Posted

December 2, 2014

Study Start

October 1, 2011

Primary Completion

December 1, 2014

Study Completion

December 1, 2019

Last Updated

March 6, 2015

Record last verified: 2015-03

Locations