Coronary Artery Disease Clinical Trial
— UCORBIOOfficial title:
Utrecht Coronary Biobank (UCORBIO)
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 |
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).
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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Netherlands | UMC Utrecht | Utrecht |
Lead Sponsor | Collaborator |
---|---|
UMC Utrecht |
Netherlands,
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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