Acarix has announces the enrolment of the final patient in the Dan-NICAD II study of non-invasive diagnostic testing in patients with suspected Coronary Artery Disease (CAD).
The study has enrolled 1,726 patients referred to coronary CT with symptoms suggestive of stable CAD from four hospitals in Denmark and was initiated in January 2018 to further establish the diagnostic accuracy of the CADScor System compared to other stratification alternatives commonly used today in parallel with securing more validated clinical data for further sophistication of the CADScor Algorithm.
Combining Dan-NICAD I and II, the CADScor data has been collected from 3,401 patients which facilitates significant substance and precision of the underlaying algorithm.
The study also includes patients below the age of 40 which provides the opportunity of a possible significant expansion of the currently identified patient group.
“We are very pleased to be able to close the inclusion period for the Dan-NICAD II study and that we have collected comprehensive data from more than 1,700 patients with suspected heart disease; data that will allow us to further ennoble the CADScor algorithm and provide further data to support the CADScor System as a clinically documented first-line diagnostic tool for ruling out chronic CAD ” said Morten Böttcher, Aarhus University Hospital, Aarhus, Denmark.
The last examinations of patients are expected during Q1 2021 in parallel with core-lab data-analysis. The result of the final analysis of the study data is expected to be submitted for publication later in 2021.