TY - JOUR

T1 - Pilot study of the multicentre DISCHARGE Trial

T2 - image quality and protocol adherence results of computed tomography and invasive coronary angiography

AU - De Rubeis, Gianluca

AU - Napp, Adriane E.

AU - Schlattmann, Peter

AU - Geleijns, Jacob

AU - Laule, Michael

AU - Dreger, Henryk

AU - Kofoed, Klaus

AU - Sørgaard, Mathias

AU - Engstrøm, Thomas

AU - Tilsted, Hans Henrik

AU - Boi, Alberto

AU - Porcu, Michele

AU - Cossa, Stefano

AU - Rodríguez-Palomares, José F.

AU - Xavier Valente, Filipa

AU - Roque, Albert

AU - Feuchtner, Gudrun

AU - Plank, Fabian

AU - Štěchovský, Cyril

AU - Adla, Theodor

AU - Schroeder, Stephen

AU - Zelesny, Thomas

AU - Gutberlet, Matthias

AU - Woinke, Michael

AU - Károlyi, Mihály

AU - Karády, Júlia

AU - Donnelly, Patrick

AU - Ball, Peter

AU - Dodd, Jonathan

AU - Hensey, Mark

AU - Mancone, Massimo

AU - Ceccacci, Andrea

AU - Berzina, Marina

AU - Zvaigzne, Ligita

AU - Sakalyte, Gintare

AU - Basevičius, Algidas

AU - Ilnicka-Suckiel, Małgorzata

AU - Kuśmierz, Donata

AU - Faria, Rita

AU - Gama-Ribeiro, Vasco

AU - Benedek, Imre

AU - Benedek, Teodora

AU - Adjić, Filip

AU - Čanković, Milenko

AU - Berry, Colin

AU - Delles, Christian

AU - Thwaite, Erica

AU - Davis, Gershan

AU - Knuuti, Juhani

AU - Pietilä, Mikko

AU - The DISCHARGE Trial Group

N1 - Correction to: https://link.springer.com/article/10.1007%2Fs00330-020-06820-x

PY - 2020

Y1 - 2020

N2 - Objective: To implement detailed EU cardiac computed tomography angiography (CCTA) quality criteria in the multicentre DISCHARGE trial (FP72007-2013, EC-GA 603266), we reviewed image quality and adherence to CCTA protocol and to the recommendations of invasive coronary angiography (ICA) in a pilot study. Materials and methods: From every clinical centre, imaging datasets of three patients per arm were assessed for adherence to the inclusion/exclusion criteria of the pilot study, predefined standards for the CCTA protocol and ICA recommendations, image quality and non-diagnostic (NDX) rate. These parameters were compared via multinomial regression and ANOVA. If a site did not reach the minimum quality level, additional datasets had to be sent before entering into the final accepted database (FADB). Results: We analysed 226 cases (150 CCTA/76 ICA). The inclusion/exclusion criteria were not met by 6 of the 226 (2.7%) datasets. The predefined standard was not met by 13 of 76 ICA datasets (17.1%). This percentage decreased between the initial CCTA database and the FADB (multinomial regression, 53 of 70 vs 17 of 75 [76%] vs [23%]). The signal-to-noise ratio and contrast-to-noise ratio of the FADB did not improve significantly (ANOVA, p = 0.20; p = 0.09). The CTA NDX rate was reduced, but not significantly (initial CCTA database 15 of 70 [21.4%]) and FADB 9 of 75 [12%]; p = 0.13). Conclusion: We were able to increase conformity to the inclusion/exclusion criteria and CCTA protocol, improve image quality and decrease the CCTA NDX rate by implementing EU CCTA quality criteria and ICA recommendations. Key Points: • Failure to meet protocol adherence in cardiac CTA was high in the pilot study (77.6%). • Image quality varies between sites and can be improved by feedback given by the core lab. • Conformance with new EU cardiac CT quality criteria might render cardiac CTA findings more consistent and comparable.

AB - Objective: To implement detailed EU cardiac computed tomography angiography (CCTA) quality criteria in the multicentre DISCHARGE trial (FP72007-2013, EC-GA 603266), we reviewed image quality and adherence to CCTA protocol and to the recommendations of invasive coronary angiography (ICA) in a pilot study. Materials and methods: From every clinical centre, imaging datasets of three patients per arm were assessed for adherence to the inclusion/exclusion criteria of the pilot study, predefined standards for the CCTA protocol and ICA recommendations, image quality and non-diagnostic (NDX) rate. These parameters were compared via multinomial regression and ANOVA. If a site did not reach the minimum quality level, additional datasets had to be sent before entering into the final accepted database (FADB). Results: We analysed 226 cases (150 CCTA/76 ICA). The inclusion/exclusion criteria were not met by 6 of the 226 (2.7%) datasets. The predefined standard was not met by 13 of 76 ICA datasets (17.1%). This percentage decreased between the initial CCTA database and the FADB (multinomial regression, 53 of 70 vs 17 of 75 [76%] vs [23%]). The signal-to-noise ratio and contrast-to-noise ratio of the FADB did not improve significantly (ANOVA, p = 0.20; p = 0.09). The CTA NDX rate was reduced, but not significantly (initial CCTA database 15 of 70 [21.4%]) and FADB 9 of 75 [12%]; p = 0.13). Conclusion: We were able to increase conformity to the inclusion/exclusion criteria and CCTA protocol, improve image quality and decrease the CCTA NDX rate by implementing EU CCTA quality criteria and ICA recommendations. Key Points: • Failure to meet protocol adherence in cardiac CTA was high in the pilot study (77.6%). • Image quality varies between sites and can be improved by feedback given by the core lab. • Conformance with new EU cardiac CT quality criteria might render cardiac CTA findings more consistent and comparable.

KW - Angiography, coronary

KW - Coronary artery disease

KW - CT angiography

KW - Medical imaging

KW - Trial protocols

U2 - 10.1007/s00330-019-06522-z

DO - 10.1007/s00330-019-06522-z

M3 - Journal article

C2 - 31844958

AN - SCOPUS:85076803734

VL - 30

SP - 1997

EP - 2009

JO - European Radiology

JF - European Radiology

SN - 0938-7994

IS - 4

ER -