INCOAG: Whole-blood coagulation profile

Cardiovascular diseases remain the principal cause of death and ischemic heart disease and stroke comprise >50% of total cardiovascular mortality. Arterial thrombosis is the principal cause of acute ischemic cardiovascular death due to occlusion of coronary or carotid arteries leading to myocardial infarction and stroke, respectively. Thrombosis in the venous system is also an important cause of acute death, due to pulmonary embolism. In the Netherlands annually 30,000 patients suffer a deep venous thrombosis and in 35% of these patients pulmonary embolism occurs. In patients with symptomatic pulmonary embolism the mortality rate is 5%. In addition to acute mortality, major long-term morbidity consists of heart failure and hemiplegia in case of arterial thromboembolism and post-thrombotic syndrome and pulmonary hypertension in case of venous thromboembolism. Major advances have been made in the timely diagnosis and treatment of thrombosis in general, both in the venous and arterial system. Effective prevention however is still dramatically insufficient. Also monitoring of anticoagulant therapy, including home monitoring is considered in need of improvement.
One of the major reasons for the lack of effective preventive strategies is the inability to identify persons at risk of thrombosis. Literature suggests it would be possible to identify different risk levels of thrombosis with multiplex assays. The purpose of INCOAG is therefore:
1. To develop a state of the art prototype of a diagnostic assay device carrying a clinically validated combination of (miniaturized) coagulation factor assays, and including a clinical decision support module, to rapidly quantify the risk of arterial and venous thrombosis in the individual patient, based on a single blood sample.
2. To clinically validate this prototype device on patient samples from already published clinical trials for arterial and venous thrombosis and anticoagulant monitoring (road to the FDA).