Thrombotic markers as predictors for recurrent cardiovascular events after the acute coronary syndrome

Rationale:
Ischemic heart disease is the leading cause of death worldwide, killing over 6
million individuals each year, with an increasing margin into 2030. By far the
most frequent cause of ischemic heart disease is coronary atherosclerosis with
vascular plaque formation. Plaque disruption with superimposed thrombosis is
the main cause of the acute coronary syndromes (ACS) of unstable angina,
myocardial infarction, and sudden death. The number of deaths from a myocardial
infarction in the period 1980-2008 decreased by 62% from 20.352 to 7.792 and is
mainly due to faster and more adequate treatment options. However, survivors of
coronary heart disease have an increased risk for recurrent coronary events,
other vascular events and downstream consequences of coronary events. Though
not all patients will have a recurrent cardiovascular event, up till now there
are no methods for selecting those patients with the highest risk. Although
platelets are usually considered the most important factor in arterial
thrombosis, activated by rupture of an atherosclerotic plaque, there have been
recent new insights pointing more towards the importance of coagulation factors
in this process. Multiple plasma markers of activated haemostasis have been
studied in thrombotic disorders, more specifically in ACS. Many studies have
reported elevated plasma concentrations of haemostatic markers in ACS patients,
however up till now only few have tried to translate these results to the
clinic.

Objective:
The hypothesis of this study is that laboratory markers for blood coagulation,
platelet activity and inflammation may help to identify patients at risk for a
recurrent cardiovascular event after ACS. Secondary, we expect to find
differences in these markers between the patient groups with unstable angina
and acute myocardial infarction, based on the pathophysiological differences
between these diseases. Ultimately, an improved risk assessment may lead to a
more balanced choice for secondary preventive therapy in these patients.

Study design:
Prospective cohort study in 350 patients with the ACS.

Nature and extent of the burden and risks associated with participation,
benefit and group relatedness:
There are 3 venipunctures carried out. The first blood sampling is at the time
of diagnosis, either in the ambulance or at the cardiac care unit (academic
hospital Maastricht or Atrium hospital Heerlen), prior to medication or
intervention. The second blood sampling is after 1 month and the last time is 6
months after diagnosis. For the venipuncture at 1 and 6 months patients will
have to bring a visit to the heart and vascular center of the academic hospital
Maastricht or Atrium hospital Heerlen. At 12 and 24 months telephone
questionnaires will be conducted.
Regarding the control population, only the blood already collected in the
ambulance will be used. No further venipunctures will be carried out.