New and rapid diagnostic method for cardiovascular disease and prothrombotic state

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Factor VII (FVII) plays an important role in initiation of the tissue factor-induced coagulation pathway and an increase in FVII coagulant activity (FVIIc) has been proposed as an independent risk factor for coronary artery disease. However, it remains uncertain whether high FVIIc levels are due to an increase in the activation of FVII or due to an increase in the concentration of FVII mass. We developed a new fluorogenic assay for plasma activated FVII (FVIIa) using soluble tissue factor. The sensitivity of this assay ranged from 0.2 to 1,000 ng of FVIIa per milliliter of plasma. Plasma FVIIa levels were measured in 110 healthy subjects and 93 patients with hypertension, diabetes mellitus, and/or cardiovascular disease. The mean plasma FVIIa level in healthy Japanese individuals was 2.5 ng/ml and it was lower than that in Western subjects. Aging increased both the FVIIa level and FVII mass, while menopause mainly increased the FVII mass. Elderly patients with coronary artery disease and/or chronic cerebral infarction showed an increase in the plasma FVIIa levels and the FVIIa/FVIIag ratio. Arterial cardiovascular disease was more common in a high-FVIIa elderly group than in a low-FVIIa elderly group. Plasma FVIIa levels were not correlated with the serum levels of total cholesterol or triglycerides. The FVIIa level and the FVIIa/FVIIag ratio were positively correlated with the fibrinogen level and were negatively correlated with the body mass index and the serum albumin level in the elderly. In conclusion, aging, cardiovascular disease, and malnutrition increased the plasma FVIIa level. FVIIa levels were not correlated with the levels of lipids and the activity of hepatic synthesis, indicating that FVIIa may be an independent risk factor for cardiovascular disease.