The primary objective is to study the association between baseline (including genetic), and repeatedly measured blood biomarkers (including metabolomics and proteomics), and the incidence of cardiovascular disease. Secondary objectives are related…
ID
Source
Brief title
Condition
- Myocardial disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Acquired heart disease remains a major healthcare problem: coronary heart
disease (CHD) and heart failure (HF) are both among the top five leading causes
of death in the Netherlands. Biochemical markers (biomarkers) in the form of
plasma proteins represent major underlying pathophysiological mechanisms and
may monitor subtle changes in the heart that reflect and possibly predict
adverse changes before they become clinically apparent. Previous studies within
the Erasmus MC have shown that a study design with high frequency repeated
biomarker sampling is valuable for prognostication in CHD and HF patients. This
suggests that such an approach may be valuable for the prediction of incident
CHD and HF in persons without clinically manifested disease as well. A group
ideally suited to evaluate this hypothesis using the repeated measurements
design is the Dutch donor population.
Study objective
The primary objective is to study the association between baseline (including
genetic), and repeatedly measured blood biomarkers (including metabolomics and
proteomics), and the incidence of cardiovascular disease. Secondary objectives
are related to donor health, neurological disorders, cancer, haematological
disorders, kidney disorders, pulmonary disorders, gastrointestinal diseases and
liver disorders.
Study design
This is a prospective cohort study of whole blood and plasma donors in the
Netherlands. Donors will be recruited in the eight XL-locations (with
6000-10,000 donors annually) of Sanquin during one year. They will be
followed-up for a maximum of three years. Blood samples will be taken from the
sampling bag as part of regular blood/plasma donations at baseline and at every
subsequent six months. Donors will also fill in a baseline questionnaire, and a
follow-up questionnaire at each subsequent study visit.
Study burden and risks
Risks for this study are low. Venepuncture is the most invasive procedure, but
is also part of the standard donation procedure and does not introduce risk
other than minor bruising.
There are no individual benefits of participation, besides the contribution to
obtaining scientific knowledge for the future.
's-Gravendijkwal 230
Rotterdam 3015CE
NL
's-Gravendijkwal 230
Rotterdam 3015CE
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL69934.078.19 |