Stopped: The study is terminated due to cessation of the research collaboration with Russian institutions
In a prospective international multicenter observational study, 1080 stable chest pain patients (REALITY Advanced registry of CCTA patients) with the suspected chronic coronary syndrome will be enrolled. All of them will undergo computed tomography angiography, CMR and/ or SPECT, and Echo. One of the cohorts will be examined with multimodality invasive imaging including quantitative coronary angiography, FFR, QFR with or without further percutaneous coronary intervention, OCT, and some of them - with IVUS, VH-IVUS. The plaque size and relevant stenosis, a composition of the atherosclerotic lesion, major adverse cardiovascular events (all-cause death, death from cardiac causes, myocardial infarction, or rehospitalization due to unstable or progressive angina, ischemia-driven revascularization) will be judged to be related to either originally treated (culprit) lesions or untreated (non-culprit) lesions. Moreover, the clinical potential of both non-invasive and invasive imaging, as well as anatomical vs functional modalities in two real-world patient flows, will be estimated with the special focus on the natural progression of atherosclerosis, clinical outcomes, and safety (contrast-induced nephropathy, radiocontrast-induced thyroid dysfunction, and radiation dose). The diagnostic accuracy will be analyzed. The follow-up period will achieve 12 months prospectively with collected clinical events and imaging outcomes which will be determined at the baseline and 12-month follow-up. The independent ethics expertise will be provided by the Ural State Medical University (Yekaterinburg, Russia) and Central Clinical Hospital of the Russian Academy of Sciences (Moscow, Russia). The monitoring of the clinical data with imaging as well as further CoreLab expertise (expert-level post-processing multimodal imaging software of Medis Imaging B.V., Leiden, The Netherlands) will be provided by De Haar Research Task Force, Amsterdam-Rotterdam, the Netherlands. FFR-CT is scheduled to be assessed by the ElucidVivo Research Edition software from Elucid Bio, Boston, MA, U.S.A. The REALITY project is a part of the JHWH (Jahweh) International Advanced Cardiovascular Imaging Consortium. The main objective of the Consortium that is uniting international efforts of both Academia and Industry is a synergistic development of the advanced machine-learning imaging software in order to integrate benefits of both non-invasive and invasive imaging providing the daily clinical practice with the robust tool for the anatomical and functional examination of coronary atherosclerosis, PCI-related arterial remodeling, and relevant myocardial function.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Change of per cent of plaque burden from baseline to follow-up as assessed by either CCTA or QCA
Timeframe: At 12 months after the baseline imaging procedure
Number of participants with major adverse cardiac events that are related to plaque burden
Timeframe: At 12 months after the baseline imaging procedure
Head-to-head comparison between non-invasive (CCTA, FFR-CT, CMR, SPECT, Echo) and invasive imaging (QCA, FFR, QFR, OCT, IVUS, VH-IVUS)
Timeframe: At baseline and 12 months after the baseline imaging procedure
Non-invasive imaging for risk stratification
Timeframe: At 12 months after the baseline imaging procedure
Invasive imaging for risk stratification
Timeframe: At 12 months after the baseline imaging procedure
Diagnostic accuracy of non-invasive and invasive imaging
Timeframe: At baseline and 12 months after the baseline imaging procedure
Progression of atherosclerosis and plaque composition in comparison between non-invasive and invasive imaging methods
Timeframe: At baseline and 12 months after the baseline imaging procedure
Comparison between anatomical and functional imaging modalities
Timeframe: At baseline and 12 months after the baseline imaging procedure