Athero-thrombosis risk in patients with venous thrombo-embolism

Recently there has been a lot of interest in a possible link between venous and
arterial thrombosis. The association has been extensively studied in
case-control and cohort studies of both retrospective and prospective design.
In individuals with venous thrombo-embolism (VTE), a high risk of subsequent
(fatal and nonfatal) arterial thrombotic events has been observed. An
association between endothelial dysfunction and increased intima media
thickness, both signs of early, preclinical atherosclerosis and VTE has also
been shown, especially in unprovoked VTE. All this evidence has led to the
assumption that individuals who have suffered from VTE have a higher risk of
subsequent arterial thrombosis. We therefore propose a study in which VTE
patients are screened for cardiovascular risk factors. The number of patients
with VTE and an elevated risk score determined by a validated risk assessment
tool (SCORE) for cardiovascular disease will be assessed.

Primary objective:
To determine the individual cardiovascular risk profile, using validated risk
score screening methodologies (Framingham, PROCAM, Reynolds Risk Score and
SCORE) in patients with VTE to evaluate how many patients are at risk for
future cardiovascular events and will potentially benefit from cardiovascular
prevention.

Secundary objectives:

- To determine in how many patients an increased risk of cardiovascular disease
was previously unrecognized.
- To determine whether patients with unprovoked VTE more frequently have an
unfavorable cardiovascular risk profile compared to those with provoked VTE.

In this multi-centered prospective cohort study, patients between 40 and 79
years of age presenting with a first or recurrent episode of deep vein
thrombosis or pulmonary embolism will be recruited from the Department of
Vascular Medicine of the Academic Medical Centre in Amsterdam and of the
Slotervaart Hospital in Amsterdam. During the routine outpatient clinic check
up visit three to six months after the VTE, analysis of the risk of
cardiovascular events will be performed. A clinical history will be obtained
from all patients regarding family history of cardiovascular disease, smoking,
co-morbidity and medication. Measurements of blood pressure (three times),
waist hip ratio (WHR), and BMI will take place during this visit. Blood will be
drawn for blood glucose levels, HbA1c, lipid profile (levels of total
cholesterol, HDL-c, LDL-c, and triglycerides), renal function (serum
creatinine) and hsCRP. A urine sample will be analysed for urine albumine and
creatinine. Furthermore an electrocardiogram will be made for all patients. The
ten-year risk of fatal and non-fatal cardiovascular events for each patient
will be determined using risk score screening methodologies (Framingham,
PROCAM, Reynolds Risk Score and SCORE).

The burden and risk associated with participation are minimal. Participants
will be asked to visit our studycentre on a single occasion for 30 minutes.
Since bloodsampling will be performed in a fasting state, participants will
have to refrain from eating and drinking prior to their visit. The only risk
for the subjects is a hematoma as a result of the venapuncture. The
participants can gain personal benefit from the study since analysis of their
cardiovascular risk is performed and associated medical advice is given.