Natural History of Coronary Atherosclerosis in Real-World Stable Chest Pain Patients Underwent Computed Tomography Angiography in Comparison With Invasive Multimodality Imaging

Summary

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.

Conditions

• Coronary Atherosclerosis
• Coronary Artery Disease
• Contrast-induced Nephropathy
• Cerebrovascular Disease
• Alzheimer Disease
• Chronic Coronary Insufficiency
• Stable Chronic Angina

Interventions

RADIATION

Coronary computed tomography angiography

The coronary arteries will be visualized with the MSCT scan CT 5000 Ingenuity (Philips, The Netherlands) or systems from any other vendors.

RADIATION

Quantitative coronary angiography, intravascular imaging with percutaneous intervention

Coronaries will be shot with Artis zee (Siemens, Germany) or systems from any other vendors. In case if necessary the procedure will be delayed for intravascular imaging (FFR, QFR, OCT, IVUS, VH-IVUS) and/ or percutaneous intervention (with implantation of the medical device).

Sponsors & Collaborators

• Ural State Medical University

  collaborator OTHER

• De Haar Research Task Force

  collaborator INDUSTRY

• Center of Endosurgery and Lithotripsy, Moscow, Russia

  collaborator OTHER

• JHWH International Advanced Cardiovascular Imaging Consortium

  collaborator UNKNOWN

• Medis Medical Imaging Systems B.V.

  collaborator UNKNOWN

• Pie Medical Imaging B.V.

  collaborator UNKNOWN

• De Haar Research Foundation

  collaborator OTHER

• Central Clinical Hospital of the Russian Academy of Sciences

  lead OTHER_GOV

Principal Investigators

• Alexander Kharlamov, M.D., FESC, FACC, FEACVI · De Haar Research Task Force, Amsterdam-Rotterdam, The Netherlands

• Alexey Sozykin, M.D., D.Sc. · Central Clinical Hospital of the Russian Academy of Sciences

Eligibility

Min Age

40 Years

Max Age

79 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-05-31

Primary Completion

2016-12-31

Completion

2022-08-31

Countries

• Estonia
• Netherlands
• Russia

Study Locations