TerminatedNot Applicable

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

Stopped: The study is terminated due to cessation of the research collaboration with Russian institutions

Estonia, Netherlands, Russia1,080 participantsStarted 2015-05

Plain-language 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.

Who can participate

Age range

40 Years – 79 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * all stable chest pain comers with chronic coronary syndrome or angina equivalent consistent with the manifestation of the stable coronary artery disease (by the 2019 Guidelines on Chronic Coronary Syndrome); * age between 40 and 79 years old; * patient must have one or two-vessel disease in a native coronary vessel requiring or not requiring PCI without indications for immediate bypass surgery with any SYNTAX score; * lesions may be either de novo or restenotic; * successful, uncomplicated PCI could be performed in the culprit vessels and all culprit lesions, but there should be no events or complications between the procedures of PCI in the past and six months before admission to the Chest Pain Center; * the non-culprit vessel should have no flow-limiting lesions (but any plaque burden) and be available for imaging. The non-culprit vessel must be considered safe for imaging evaluation; Exclusion Criteria: * any acute comorbidities; * patient has had a documented ST-elevation acute myocardial infarction within the 24 hours or acute coronary syndrome (unstable angina, myocardial infarction) during four weeks before admission to the Chest Pain Center; * patient has had a recent PCI (last 6 months before admission to the Chest Pain Center) unless the patient is undergoing a staged procedure for dual vessel treatment; * unprotected left main lesion location; * imaging evidence of severe calcification (CCTA calcium scoring with a CAC\>1000) or marked tortu…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT02440646

SponsorCentral Clinical Hospital of the Russian Academy of Sciences

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2016-12

View on ClinicalTrials.gov More Coronary Atherosclerosis trials

Plain-language summary

Who can participate

Age range

40 Years – 79 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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