Clinical application of quantitative coronary angiography using the CAAS system: preliminary results of the INTACT study (International Nifedipine Trial on Antiatherosclerotic Therapy).

It is the objective of the INTACT-study to test in man, whether a significant retardation of the progression of coronary artery disease is attainable with the Ca-antagonist nifedipine; this may be possible on the basis of numerous animal experiments. INTACT is a prospective, randomized, double blind, placebo controlled investigation in 423 patients with preferably early stages of coronary sclerosis in whom a progression of the disease seems likely. A proper coronary angiogram led to inclusion of the patients in the study (October 1983-June 1985). Over the following 3-years-period patients received either nifedipine 80 mg/day or placebo. The study is concluded by a control coronary angiogram with angiographic projections which are identical to those of the first coronary angiography. The extent of coronary sclerosis is objectivated by computer-assisted quantitative measurement of the entire coronary arterial system with the CAAS-system (Rotterdam). For definition purposes the coronary artery system subdivided into 25 segments. Parameters for progression assessment will be mean segment diameter, minimal obstruction diameter, percentage severity of obstruction, length of obstruction and plaque area. So far 4826 coronary segments have been analyzed from the first angiograms of 383 patients. Per patient an average of 12.6 different segments could be evaluated in at least one angiographic projection. The major coronary segments could be measured in 72-93% of the patients in one or more angiographic projections (at the average about 2 different projections). Five hundred and forty-six coronary obstructions were analyzed; 131 of these were total occlusions. Only 9% of the length of the vessel contours detected by the computer algorithm required manual correction by the operators, suggesting a high reliability of the system. It can be concluded that quantitative measurement of the complete coronary artery system can indeed be obtained in a large angiographical multicenter study such as INTACT.

RCT Entities:   Population Interventions Outcomes