Overview on the project

CARDIOPROOF is a project to determine the applicability and effectiveness of predictive modelling and simulation tools for cardiology.

Previous Virtual Physiological Human (VPH) projects:

  • developed powerful tools for computer-based modelling of various cardiovascular (CV) diseases;
  • raised expectations to make such tools available for:
    • early diagnosis
    • predicting disease behaviour and evolution
    • predicting treatment outcomes.

CARDIOPROOF‘s motivation:

Translation into routine clinical environment has remained challenging and substantially bounded, because of lack of sufficient:

  • Validation: Data of methods validity in clinical studies is sparse
  • Comparative effectiveness: The comparative effectiveness of the methods is still unknown: Do they result in different treatment decisions? What is the comparative effect on costs?
  • Usability and interoperability: Software application and data management do not comply with clinical requirements (too complex, labour and time consuming)

CARDIOPROOF is a project to determine the applicability and effectiveness of predictive modelling and simulation tools for cardiology. Consolidating the outcomes of previous Virtual Physiological Human (VPH) projects, CARDIOPROOF will validate the tools in interrelated clinical trials. These trials will be conducted at three European centres of excellence in cardiac treatment: The Ospedale Pediatrico Bambin Gesù, in Rome; University College of London’s Great Ormond Street Hospital for Children NHS Foundation Trust (GOSH); and the Deutsches Herzzentrum Hospital of Berlin.

Previous VPH efforts, such as Health-e-Child, Sim-e-Child, and EUHeart, have developed some very powerful tools for computer-based modelling of various cardiovascular (CV) diseases, raising significant expectations to make such tools available for early diagnosis and for predicting disease behaviour and evolution as well as treatment outcomes. As yet, however, the translation into a routine clinical environment has remained challenging and substantially bounded. Despite an increasing interest from the medical community to apply VPH concepts in the field of CV diseases, limited results have been achieved so far.

CARDIOPROOF focuses on patients with aortic valve disease and aortic coarctation, which, if left untreated, can result in irreversible heart failure. This means that treatment becomes mandatory, the optimum timing and type of treatment still remain difficult to determine. With more than 50,000 interventions per year within the EU, the diseases addressed by CARDIOPROOF have a significant socio-economic impact. Present clinical guidelines are highly complex and rely mostly on imaging diagnostics and clinical parameters, without benefiting, as yet, from patient-specific disease modelling based prediction.

CARDIOPROOF will test the capacity of clinicians to obtain early diagnosis, prediction of disease behaviour and evolution and treatments outcomes by appropriately applying multi-scale modelling and simulation tools within two ad hoc clinical proof-of-concept trials on patients with aortic valve disease (AVD) and aortic coarctation (CoA), first aggregating information from multiple biological levels with regard to the patient-specific disease state, and subsequently using these data to model the response to various treatment strategies. Following this direction, CARDIOPROOF will be able to achieve the development and integration of software technologies and human-computer interaction techniques into decision support and treatment planning system, based on powerful personalised models of organ and disease that will be directly used by the healthcare professionals. Furthermore, through validation, enhanced usability, accessibility and workflow integration.

CARDIOPROOF will overcome knowledge and technology gaps which have until now been hindering the translation and deployment of VPH models into the clinical environment and an increased acceptance and use of predictive models by healthcare professionals. Finally, CARDIOPROOF pays particular attention to facilitating clearance for pre-clinical validation processes by acquiring the expected clinical evidence of the benefits of the use of computer based models. In addressing these targets, CARDIOPROOF will in fact take into account also the economic aspect of the treatments, (certainly a not negligible issue in an environment where cardiac medical costs are currently absorbing a growing amount of financial resources and appear to be rapidly rising), by performing innovative comparative outcomes analysis and by developing a comparative effectiveness study, addressing, in this way, the goal of leading to a significant reduction of costs through the use of VPH technologies.