News | Patient Monitors | March 30, 2017

Acarix CADScor System Rules Out Coronary Artery Disease With 97 Percent Negative Predictive Value

Handheld system combines acoustic detection of turbulent arterial flow and myocardial movement with advanced algorithms to produce a patient-specific CAD score in less than 10 minutes

Acarix, CADScor System, coronary artery disease detection, clinical study, ACC.17

March 30, 2017 — Acarix AB recently announced the results from a new multi-center trial of its handheld CADScor System for non-invasive, non-radiation acoustic detection of coronary artery disease (CAD). The results were presented at the American College of Cardiology (ACC) 2017 Annual Scientific Meeting, held March 17-19 in Washington, D.C., and showed the handheld CADScor System rules out CAD with 97 percent negative predictive value. The results confirm the company’s previously announced figures which, prior to this study, were unconfirmed.

The trial involved 1,675 patients from two Danish hospitals with a low to intermediate likelihood of CAD referred for cardiac computed tomography angiography (CTA) and showed that the handheld CADScor System rules out CAD with 97 percent negative predictive value. Acarix believes this opens the possibility of use as a frontline test, reducing patient anxiety and waiting times, as well as improving triage for patients needing more expensive and invasive diagnostic modalities.

The system combines acoustic detection of turbulent arterial flow and myocardial movement with advanced algorithms in a handheld device to provide a patient-specific CAD score in less than 10 minutes. The research was led by Principal Investigator Morten Böttcher, M.D., Ph.D., FESC, and by Simon Winther, M.D., Ph.D., Department of Cardiology, Aarhus University Hospital, Denmark. “Despite the availability of improved risk stratification algorithms, the incidence of normal investigations such as nuclear or CT imaging remains high. We therefore tested the diagnostic accuracy of the CADScor System for ruling out CAD to see if it could be used to reduce demand for more advanced diagnostic modalities. We have concluded that, with its ability to rule out CAD with a 97 percent negative predictive value, this advanced, easy to use, stethoscope like device could indeed be deployed as a frontline test,” they said.

A CAD-score was recorded in all 1,675 patients enrolled in the trial, with the CAD-score algorithm including both acoustic features and clinical risk factors (gender, age and hypertension). Low risk was indicated by a CAD-score value less or equal to 20. The algorithm CAD-score version 3 was developed using recordings from 711 patients from previous studies and a training cohort of 589 patients from the present study. The remaining 1,086 patients were used as the validation cohort. The CAD-score was successfully analyzed in 1,464 patients (87 percent). Hemodynamic-significant CAD was present in 134 patients (9.3 percent). There were no differences in the performance of the CAD-score algorithm in the training vs. validation cohorts. In the entire cohort, the CAD-score differed between coronary artery calcium score (CACS) groups CACS=0 (n=745), CACS 1-400 (n=550) and CACS more than 400 (n=142); CAD-score: 17 ±11, 24 ±12, and 30 ±12 (p less than 0.001). CAD-score was also significantly lower for patients without vs. with hemodynamic-significant stenosis 20 ±12 vs 30 ±12 (p less than 0.001). Diagnostic performance evaluated by receiver operating characteristic curve showed an accuracy of: 72 percent (CI: 67-77 percent). CAD-score cut-off less or equal to 20 had an accuracy of:

  • Sensitivity: 81 percent (CI: 74-88 percent);
  • Specificity: 53 percent (CI: 50-56 percent);
  • PPV: 15 percent (CI: 13-18 percent); and
  • NPV: 97 percent (CI: 95-98 percent).

For more information: www.acarix.com


Related Content

News | Patient Monitors

December 26, 2023 — MindMics, Inc. reported results from a clinical study of revolutionary earbuds that use a new ...

Home December 26, 2023
Home
Feature | Patient Monitors | By Amit Shah, MD, MSCR

I work at Emory University in a multidisciplinary group that is employing medical technologies to improve our ...

Home May 05, 2022
Home
News | Patient Monitors
March 11, 2022 – Bittium will join the 65th Congress of the German Society for Clinical Neurophysiology and Functional ...
Home March 11, 2022
Home
News | Patient Monitors

June 18, 2019 – New study results validate the effectiveness of the Saranas Early Bird Bleed Monitoring System to sense ...

Home June 18, 2019
Home
News | Patient Monitors

August 16, 2018 — Lexington Biosciences Inc. recently announced the completion of the initial HeartSentry study ...

Home August 16, 2018
Home
Technology | Patient Monitors

May 16, 2018 — Itamar Medical Ltd. announced the launch of SleePath, the first integrated e-health sleep apnea care ...

Home May 16, 2018
Home
News | Patient Monitors

March 9, 2018 — Philips recently announced the integration of its IntelliVue Guardian with automated Early Warning ...

Home March 09, 2018
Home
Technology | Patient Monitors

December 8, 2016 — Corsens Medical Ltd. announced that it has received clearance for a Pre-Marketing Notification (510(k ...

Home December 08, 2016
Home
News | Patient Monitors

May 26, 2016 — Corsens Medical Ltd. announced it has successfully completed filing of a Pre-Marketing Notification (510 ...

Home May 26, 2016
Home
Technology | Patient Monitors

February 11, 2016 — Royal Philips announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the Expression ...

Home February 11, 2016
Home
Subscribe Now