ongitUdinal assessments for early detection of Cardiovascular dIsease in blood Donors
- Conditions
- Cardiovascular disease10028593
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 5000
Inclusion Criteria
50 years or older
Active donor (two or more donations in year before inclusion)
One or more cardiovascular risk factor (smoker, obesity BMI 30 or higher,
hypertension or antihypertensive medication, hypercholesterolemia or statin
use, type 2 diabetes or medication, family history of cardiovascular disease
before 65 years
Exclusion Criteria
Donors that do not master the Dutch language will be excluded
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary study endpoint is incidence of cardiovascular disease, comprising<br /><br>both CHD and HF events. This endpoint is defined as cardiovascular death, or a<br /><br>hospital admission for an acute coronary syndrome (ACS), percutaneous coronary<br /><br>intervention (PCI), coronary artery bypass surgery (CABG), or newly diagnosed<br /><br>HF.<br /><br>The main study parameters are the blood biomarkers, these will be determined<br /><br>batch wise after all blood samples are collected.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary study endpoints will include the individual components of the primary<br /><br>endpoint (cardiovascular death, non-fatal CHD, myocardial infarction,<br /><br>hospitalization for newly diagnosed HF) and combinations thereof, as well as<br /><br>all-cause mortality. Secondary study endpoints will also include a variety of<br /><br>donation-related endpoints (e.g. iron and protein deficiencies), neurological<br /><br>disorders (including dementia and stroke), cancers (including breast cancer,<br /><br>colon cancer, prostate cancer), haematological disorders, kidney disorders,<br /><br>pulmonary disorders, gastrointestinal diseases and liver disorders. </p><br>