Dan-NICAD - Danish Study of Non-Invasive Diagnostic Testing in Coronary Artery Disease

Primary study CCTA is currently the first choice to rule out coronary artery disease (CAD) in patients with typical or atypical chest pain. 4500 patients are annually examined with CCTA, in the Central Jutland Region of Denmark, and approximately 80% are discharged after ruling out CAD. CCTA is a diagnostic scan that exposes the patients to radiation, therefore a better risk stratification prior to the test is desirable. The CADscore is a newly developed danish technology that has been tested so far in 1000 patients. An area under the curve of the receiver operating characteristic (AUC of ROC) of 75-80 has been determined compared to conventional coronary angiography using quantitative coronary angiography (CCA-QCA). This indicates that the CADscore could potentially be used to diagnose CAD as a supplement or risk stratification prior to CCTA.

We aim to evaluate the CADscore in a large clinical trial including 2000 patients that by clinical indication undergo cCTA. After cCTA approximately 20 % (400 patients) will need evaluation by CCA with FFR. CADscore results will be compared to CCTA and CCA-QCA. Secondary, the CADscore will be compared to the results of CCA-FFR and perfusion scans, Cardiac-MRI and SPECT.

Substudies

1. Perfusion scans

CCTA demonstrates good diagnostic performance for detection and exclusion of anatomic coronary artery stenosis, but several studies have previously shown that CCTA has a low positive predictive value for identification of hemodynamically significant CAD. This emphasizes the need for additional tests to evaluate the severity (or exclusion) of hemodynamically significant CAD. Measurement of FFR during CCA represents the "gold standard" for assessment of the hemodynamic significance of coronary artery stenosis. The disadvantage of CCA with FFR is that it is an invasive procedure.