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Chronic Pain Canada

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

TerminatedNCT02440646
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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…

Study details

Official title
The Natural History of Coronary Atherosclerosis Within the Concept of the Glagovian Arterial Remodeling in REAL-world Stable Chest Pain Population Who Underwent nonInvasive compuTed tomographY Angiography in Comparison With Invasive Quantitative Coronary Angiography and Multimodality Imaging Handled by the Advanced Post-processing Software: Clinical potentIal and Safety
Conditions
Interventions
  • Radiation: Coronary computed tomography angiography
  • Radiation: Quantitative coronary angiography, intravascular imaging with percutaneous intervention
Sponsor
Central Clinical Hospital of the Russian Academy of Sciences
Collaborators
Ural State Medical University; De Haar Research Task Force; Center of Endosurgery and Lithotripsy, Moscow, Russia; JHWH International Advanced Cardiovascular Imaging Consortium; Medis Medical Imaging Systems B.V.; Pie Medical Imaging B.V.; De Haar Research Foundation
Start date
2015-05
Primary completion
2016-12
Sex
All
Age range
from 40 Years to 79 Years
Results posted
No results posted in this snapshot
Countries
Estonia, Netherlands, Russia
Total sites listed
4

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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 tortuosity of the vessel; * culprit lesion is located within or distal to an arterial or saphenous vein graft; * untreated, significant coronary lesion with a \>50-75% diameter stenosis remaining in the culprit vessel after the planned intervention (branch stenosis is permitted) unless allowed by the Heart Team, or the Institutional Review Board (IRB), or the Data Safety and Monitoring Board (DSMB); * lesion or vessel contains visible thrombus within the imaging procedure; * patient has an additional lesion that requires intervention within 180 days after the initial hospitalization unless allowed by the Heart Team, or the IRB, or the DSMB; * any diameter stenosis more than 75% in the non-culprit vessel; * indications for immediate bypass surgery within one year of enrollment with the SYNTAX above 34 (including multi-vessel disease requiring intervention in all three major coronary arteries); * decompensated hypotension or heart failure requiring intubation, inotropes, intravenous diuretics, o…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02440646