Reference Framework for Implementation of Cardiovascular Imaging in Clinical Trials. A Scientific Statement of the European Association of Cardiovascular Imaging (EACVI) of the ESC
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
- Arti A. Ramkisoensing (ORCID: https://orcid.org/0000-0001-9036-6935)
- Jaume Agüero (ORCID: https://orcid.org/0000-0001-7416-871X)
- Victoria Delgado (ORCID: https://orcid.org/0000-0002-9841-2737)
- Elena Surkova (ORCID: https://orcid.org/0000-0001-5334-8551)
- Maribel González‐Del‐Hoyo (ORCID: https://orcid.org/0000-0003-0587-050X)
- Marianna Fontana (ORCID: https://orcid.org/0000-0002-9233-9831)
- Riccardo Maria Inciardi (ORCID: https://orcid.org/0000-0003-4846-8529)
- Philippe B. Bertrand (ORCID: https://orcid.org/0000-0001-6324-6874)
- Nina Ajmone Marsan (ORCID: https://orcid.org/0000-0001-7208-5769)
- Michael T. Lu (ORCID: https://orcid.org/0000-0003-4696-9610)
- Maja Čikeš (ORCID: https://orcid.org/0000-0002-4772-5549)
- Marc R. Dweck (ORCID: https://orcid.org/0000-0001-9847-5917)
- Andreas A. Giannopoulos (ORCID: https://orcid.org/0000-0002-0938-3170)
- Andrea Baggiano (ORCID: https://orcid.org/0000-0002-8261-4529)
- Anna Baritussio (ORCID: https://orcid.org/0000-0002-6900-6705)
- Alessia Gimelli
Institutions
- University of Padua (IT)
- University Hospital Centre Zagreb (HR)
- University of Zurich (CH)
- Leiden University Medical Center (NL)
- Royal Brompton & Harefield NHS Foundation Trust (GB)
- Instituto de Salud Carlos III (ES)
- Harefield Hospital (GB)
- Massachusetts General Hospital (US)
- Centro Cardiologico Monzino (IT)
- AstraZeneca (South Korea) (KR)
- University Hospital of Zurich (CH)
- Lung Institute (US)
- Surgical Specialties (Canada) (CA)
- AstraZeneca (Australia) (AU)
- Amyloidosis Foundation (US)
- Centro de Investigación Biomédica en Red (ES)
- AstraZeneca (Poland) (PL)
- Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol (ES)
- Ziekenhuis Oost-Limburg (BE)
- Fondazione Toscana Gabriele Monasterio (IT)
- University College London (GB)
- Imperial College London (GB)
- University of Brescia (IT)
- University of Edinburgh (GB)
Publication Details
- Journal
- European Heart Journal - Cardiovascular Imaging
- Published
- 2026-07-01
- DOI
- https://doi.org/10.1093/ehjci/jeag171
- Primary Topic
- Cardiac Imaging and Diagnostics
- Type
- article
- Field-Weighted Citation Impact
- 0.00