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LongitUdinal assessments for early detection of Cardiovascular dIsease in blood Donors

LongitUdinal assessments for early detection of Cardiovascular dIsease in blood Donors - LUCID

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON48186
Enrollment
5000
Registered
2021-07-28
Start date
2019-10-01
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular disease

Interventions

None listed

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Donors that do not master the Dutch language will be excluded

Design outcomes

Primary

MeasureTime frame
The primary study endpoint is incidence of cardiovascular disease, comprising both CHD and HF events. This endpoint is defined as cardiovascular death, or a hospital admission for an acute coronary syndrome (ACS), percutaneous coronary intervention (PCI), coronary artery bypass surgery (CABG), or newly diagnosed HF. The main study parameters are the blood biomarkers, these will be determined batch wise after all blood samples are collected.

Secondary

MeasureTime frame
Secondary study endpoints will include the individual components of the primary endpoint (cardiovascular death, non-fatal CHD, myocardial infarction, hospitalization for newly diagnosed HF) and combinations thereof, as well as all-cause mortality. Secondary study endpoints will also include a variety of donation-related endpoints (e.g. iron and protein deficiencies), neurological disorders (including dementia and stroke), cancers (including breast cancer, colon cancer, prostate cancer), haematological disorders, kidney disorders, pulmonary disorders, gastrointestinal diseases and liver disorders.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)