Reference Framework for Implementation of Cardiovascular Imaging in Clinical Trials. A Scientific Statement of the European Association of Cardiovascular Imaging (EACVI) of the ESC

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.