SMARTool H2020 project: an ICT Approach to Coronary Artery Disease Management:
Clinical Study Design and Preliminary Data

Purpose: The difficulty of identifying and predicting which "high risk plaque" in which "high risk patient" will cause major adverse coronary events (MACE) is widely acknowledged.
SMARTool project (Horizon 2020 EU) , aims at developing an e-Health platform for assessment of CAD progression and associated MACE. It includes plaque-specific models, based on coronary CT angiography (CTA) for prediction of plaque growth and formation and functional assessment of stenosis by virtual fractional flow reserve (vFFR) computation, combined with patient risk, as derived from multiomics profiling of patient phenotype and genotype.
Methods: Cutting-edge technological solutions (coronary 3D reconstruction and modeling), miniaturization of tools for ELISA-on-chip, and “on cloud” environment are adopted to develop a user-friendly clinical decision support system (CDSS).
Molecular putative markers of CAD presence and progression over 5-6 yrs will be identified and plaque models applied to and validated by a second CTA scan in 300 patients, who represent the learning cohort.
Results: Preliminary results in 71 patients with either no CAD (28%) or stable non obstructive (48%) or obstructive CAD (24%) at baseline, evidence a 63% incidence of total plaque volume increase on the second scan, associated to a higher number of MACE and PCI and unrelated to clinical risk factors and to statin treatment.
Conclusions: A reliable prediction of plaque growth/formation in CAD patients, as provided by SMARTool CDSS, may help improving prevention of CAD growth-related MACE.

Acknowledgements: This project has received funding from the EU H2020 research and innovation programme under grant agreement No 689068.