MYOcardial ischemia detection by circulating bioMARKERs: * the MYOMARKER-study*

Coronary artery disease (CAD) is a leading cause of morbidity and mortality in
de the Netherlands and prevalence of angina in western populations is high.
Early diagnosis of CAD is essential, because of improvement in prognosis
following timely interventions. On the other hand, early rule out of CAD
reduces costs (e.g. diagnostic procedures, hospital admissions) and patient
burden. However, the current diagnostic approach for suspected CAD in the
cardiology outpatient clinic is based on an individuals* pre-test probability
(PTP) of having CAD, and thus heterogeneous, due to dependency of diagnostic
test accuracy on PTP. Hence, there is a clinical need for sensitive biomarkers
for ischemic CAD. Recently, both plasma extracellular vesicle (EV)
protein/miRNA expression and plasma gene-expression profiles of circulating
cells are reported to have changed expression in hypoxic myocardium, and are
therefore potentially valuable sensitive diagnostic and/or prognostic
biomarkers for ischemic coronary artery disease.

To analyse the diagnostic and prognostic value of plasma EV protein/miRNA and
gene expression profiles of circulating cells for objectified ischemic coronary
artery disease in patients with complaints suspect for angina pectoris

Prospective diagnostic and prognostic cohort study.
Ahead of radionuclide myocardial perfusion imaging (rMPI), venous blood (5x10cc
and 2x4.5cc) will be obtained from the intravenous cannula (peripheral) that is
already inserted (standard clinical procedure) during preparation for rMPI. The
blood will be collected for the assessment of microvesicles and circulating
cells. In addition, patients will be asked to fill out a (short) questionaire
regarding nature and intenstity of symptoms and cardiovasculair risk factors.
Patients will be contacted for follow-up after 1 year and 2 years (primary and
secondary cardiovascular events).

As part of the study, 7 tubes of venous blood (60cc in total) will be withdrawn
from an already inserted intravenous peripheral access (canula). Additional
harm to the patient is not expected since insertion of the intravenous canula
is part of standard clinical practice during prepartion for radionuclide
myocardial perfusion imaging. Any break in the skin carries a small risk of
infection or hematoma formation. No extra site visit of physical examination is
required, and the study will not affect the treatment of the patients. For the
purpose of follow-up, the patient will be contacted (by mail or telephone)
after 1 year and 2 years.