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NCT02304744 Clinical Trial

Utrecht Coronary Biobank (UCORBIO)

Coronary Artery Disease Clinical Trial

— UCORBIO  

Official title:
Utrecht Coronary Biobank (UCORBIO)

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02304744
Other study ID # 11/183
Secondary ID
Status Active, not recruiting
Phase N/A
First received November 26, 2014
Last updated March 5, 2015
Start date October 2011
Est. completion date December 2019

Study information
Verified date March 2015
Source UMC Utrecht
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Observational

Clinical 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 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).

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 3000
Est. completion date December 2019
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Coronary angiography

Exclusion Criteria:

- Age < 18 years.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• Observational study, no intervention.
Observational study, no intervention.

Locations
Country Name City State
Netherlands UMC Utrecht Utrecht

Sponsors (1)
Lead Sponsor Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary major adverse cardiovascular events [MACE] (Stroke, myocardial infarction, coronary revascularization, death) Stroke, myocardial infarction, coronary revascularization, death. 5 years No
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