Reference framework for implementation of cardiovascular imaging in clinical trials: a scientific statement of the European Association of Cardiovascular Imaging of the ESC

European Heart Journal - Cardiovascular Imaging, vol. 27, pp. 1585–1602

Abstract

Cardiovascular imaging is integral to modern clinical trials of new pharmaceuticals or devices, enabling refined eligibility, mechanistic insight, and sensitive assessment of treatment response and safety. Potential heterogeneity in data acquisition, analysis, and reporting may affect reproducibility and interpretability across multicentre settings. Rigorous standardization and fit-for-purpose validation of imaging endpoints can improve statistical efficiency, reduce trial duration and cost, and strengthen generated evidence. This Scientific Statement outlines a reference framework for the implementation of cardiovascular imaging in clinical trials. We provide considerations on use of imaging parameters as eligibility criteria in clinical trials, for efficacy signals evaluation, and for assessment of safety. We define principles for clinical, analytical, and operational validation of imaging endpoints, and discuss concepts of minimal clinically important change and minimal detectable change. Additionally, we discuss feasibility considerations for use of cardiovascular imaging endpoints in multicentre clinical trials where differences in equipment and local experience may exist. We delineate standards for harmonization, centralized analysis, and quality control in clinical trials, as well as challenges and opportunities of the integration of artificial intelligence within core-lab workflows. Lastly, we identify gaps in knowledge, challenge of preclinical-clinical translatability and highlight training needs and innovation priorities.

Authors 16

1. Elena Surkova corresponding

   AstraZeneca (United Kingdom) · Guy's and St Thomas' NHS Foundation Trust · Harefield Hospital · Imperial College London

   Affiliation as printed

   National Heart and Lung Institute, Imperial College London , Guy Scadding Building, Cale Street, London SW3 6LY ,

   Royal Brompton and Harefield Hospitals, Guy’s and St. Thomas’ NHS Foundation Trust , Sydney Street, London SW3 6NP ,

   Translational Sciences and Clinical Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca , 1 Francis Crick Avenue, Cambridge CB2 0AA ,

2. Alessia Gimelli

   Fondazione Toscana Gabriele Monasterio

   Affiliation as printed

   Imaging Department, Fondazione Toscana Gabriele Monasterio , Pisa ,

3. Andreas A. Giannopoulos

   University of Zurich · University Hospital Zurich

   Affiliation as printed

   Department of Nuclear Cardiology, Cardiac Imaging, University Hospital Zurich , Zurich ,

4. Nina Ajmone Marsan Aachen Department of Cardiology, Leiden University Medical Center

   Leiden University Medical Center

   Affiliation as printed

   Department of Cardiology, Leiden University Medical Center , Albinusdreef 2, Leiden 2300 RC ,

5. Andrea Baggiano

   Centro Cardiologico Monzino

   Affiliation as printed

   Perioperative Cardiology and Cardiovascular Imaging Department, Centro Cardiologico Monzino IRCCS , Milan ,

6. Maja Čikeš

   University Hospital Centre Zagreb · University of Zagreb

   Affiliation as printed

   University of Zagreb School of Medicine, Department of Cardiovascular Diseases, University Hospital Center Zagreb , Zagreb ,

7. Anna Baritussio

   University of Padua · Azienda Ospedale - Università Padova

   Affiliation as printed

   Department of Cardiac, Thoracic, Vascular Sciences and Public Health, Padua University Hospital , Padua ,

8. Arti Anushka Ramkisoensing Aachen Department of Cardiology, Leiden University Medical Center

   Leiden University Medical Center

   Affiliation as printed

   Department of Cardiology, Leiden University Medical Center , Albinusdreef 2, Leiden 2300 RC ,

9. Marc Richard Dweck

   University of Edinburgh

   Affiliation as printed

   BHF Centre for Cardiovascular Science, University of Edinburgh , Chancellors Building, Little France Crescent, Little France, Edinburgh EH16 4SB ,

10. Maribel González‐Del‐Hoyo

    University of Zurich · University Hospital Zurich

    Affiliation as printed

    Department of Cardiology, University Heart Center, University Hospital Zurich, University of Zurich , Zurich ,

11. Jaume Agüero

    Instituto de Salud Carlos III · Hospital Universitari i Politècnic La Fe · Centro de Investigación en Red en Enfermedades Cardiovasculares · Centro de Investigación Biomédica en Red

    Affiliation as printed

    Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Instituto de Salud Carlos III , Madrid ,

    Department of Cardiology, Hospital Univeristario y Politecnico La Fe , Valencia ,

12. Philippe B. Bertrand

    Ziekenhuis Oost-Limburg

    Affiliation as printed

    Deparment of Cardiology, Ziekenhuis Oost-Limburg , Genk ,

13. Marianna Fontana

    University College London

    Affiliation as printed

    National Amyloidosis Centre, University College London , London ,

14. Riccardo Maria Inciardi

    Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · University of Brescia

    Affiliation as printed

    Institute of Cardiology, ASST Spedali Civili, Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia , Brescia ,

15. Michael T. Lu

    Harvard University · Massachusetts General Hospital

    Affiliation as printed

    Cardiovascular Imaging Research Center, Massachusetts General Hospital and Harvard Medical School , Boston MA ,

16. Victoria Delgado

    Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol · Hospital Universitari Germans Trias i Pujol

    Affiliation as printed

    Centre of Comparative Medicine and Bioimaging, Institute of Research Germans Trias i Pujol, Badalona ,

    Institut del Cor, Hospital Universitari Germans Trias i Pujol, Badalona ,