Skip to main content
main-content

23.06.2018 | Original Paper

The clinical evaluation of the CADence device in the acoustic detection of coronary artery disease

Zeitschrift:
The International Journal of Cardiovascular Imaging
Autoren:
Joseph L. Thomas, Michael Ridner, Jason H. Cole, Jeffrey W. Chambers, Sabahat Bokhari, Demetris Yannopoulos, Morton Kern, Robert F. Wilson, Matthew J. Budoff

Abstract

The noninvasive detection of turbulent coronary flow may enable diagnosis of significant coronary artery disease (CAD) using novel sensor and analytic technology. Eligible patients (n = 1013) with chest pain and CAD risk factors undergoing nuclear stress testing were studied using the CADence (AUM Cardiovascular Inc., Northfield MN) acoustic detection (AD) system. The trial was designed to demonstrate non-inferiority of AD for diagnostic accuracy in detecting significant CAD as compared to an objective performance criteria (sensitivity 83% and specificity 80%, with 15% non-inferiority margins) for nuclear stress testing. AD analysis was blinded to clinical, core lab-adjudicated angiographic, and nuclear data. The presence of significant CAD was determined by computed tomographic (CCTA) or invasive angiography. A total of 1013 subjects without prior coronary revascularization or Q-wave myocardial infarction were enrolled. Primary analysis was performed on subjects with complete angiographic and AD data (n = 763) including 111 subjects (15%) with severe CAD based on CCTA (n = 34) and invasive angiography (n = 77). The sensitivity and specificity of AD were 78% (p = 0.012 for non-inferiority) and 35% (p < 0.001 for failure to demonstrate non-inferiority), respectively. AD results had a high 91% negative predictive value for the presence of significant CAD. AD testing failed to demonstrate non-inferior diagnostic accuracy as compared to the historical performance of a nuclear stress OPC due to low specificity. AD sensitivity was non-inferior in detecting significant CAD with a high negative predictive value supporting a potential value in excluding CAD.

Bitte loggen Sie sich ein, um Zugang zu diesem Inhalt zu erhalten

★ PREMIUM-INHALT
e.Med Interdisziplinär

Mit e.Med Interdisziplinär erhalten Sie Zugang zu allen CME-Fortbildungen und Premium-Inhalten der Fachzeitschriften, inklusive eines Print-Abos.

Weitere Produktempfehlungen anzeigen
Literatur
Über diesen Artikel
  1. Das kostenlose Testabonnement läuft nach 14 Tagen automatisch und formlos aus. Dieses Abonnement kann nur einmal getestet werden.

Neu im Fachgebiet Kardiologie

Mail Icon II Newsletter

Bestellen Sie unseren kostenlosen Newsletter Update Kardiologie und bleiben Sie gut informiert – ganz bequem per eMail.

Bildnachweise