Acarix started the initiation of a multicentre trial of its handheld CADScor system, which is designed to provide non-invasive, non-radiation acoustic detection of coronary artery disease. The results from the extensive study are expected to be available early 2020.
According to a press release, Acarix believes the device has the potential to both greatly improve triaging of patients and reduce the need for costly further invasive diagnostic investigations. The new study is intended to further support eligibility, document the positive effects on health economics and also expand applicability to patients 30–39 years of age.
The press release reports that the CADScor system combines ultra-sensitive phonocardiography to detect turbulent arterial flow and myocardial movement in a handheld device to provide a patient specific coronary artery disease-score in less than eight minutes. The principal investigator is Morten Böttcher (Department of Cardiology, Aarhus University Hospital, Denmark). He says: “The acoustic-based recording device, the CADScor system, enables improved risk stratification in suspected coronary artery disease patients. With a negative predictive value of 96%, this new acoustic rule-out system could potentially supplement clinical assessment to guide decisions on the need for further investigation and thereby reduce the demand for more advanced, costly and invasive diagnostic modalities.”
The trial results are expected to involve 1,500–2,000 patients with a low-to-intermediate likelihood of coronary artery disease from four Danish hospitals. The study results are expected to improve on the negative predictive value of 96%, which suggests using the CADScor system as a first-line coronary artery disease rule-out method; thus, avoiding expensive and/or invasive diagnostic modalities for many of those patients.
Acarix chief executive offiver Søren Rysholt Christiansen comments: “The existing data already show that the CADScor system quickly and cost-effectively can provide answers to the pressing issues in coronary artery disease diagnosis.” He adds: “The DAN-NICADII study we expect to gather performance and economic date supporting the CADScor system as a fast and safe frontline assessment to reduce patient referrals by approximately 50%—a win-win for patients, payers and physicians.”