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

Launched by CENTRAL CLINICAL HOSPITAL OF THE RUSSIAN ACADEMY OF SCIENCES · May 7, 2015

Keywords

ClinConnect Summary

Invasive coronary angiography with fractional flow reserve (FFR) is considered as the reference standard of daily clinical practice. This invasive approach is associated with potentially life-threatening complications, high expenditures, relatively high radiation exposure, and some patient discomfort. Noninvasive cardiac computed tomography angiography (CCTA) becomes a robust alternative to the invasive approach, especially when supported by other functional and anatomical noninvasive imaging modalities such as cardiac magnetic resonance (CMR), single-photon emission computed tomography (SP...

Gender

ALL

Eligibility criteria

• 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, or intra-aortic balloon counterpulsation (including the presence of cardiogenic shock);
• • patient has a known left ventricular ejection fraction \<40% or history of decompensated congestive heart failure;
• • uncontrolled tachycardia or refractory ventricular arrhythmia;
• • presence of cardiac implants;
• • acute conduction system disease requiring a pacemaker;
• • uncontrolled hypokalemia or digitalis intoxication;
• • uncontrolled arterial hypertension;
• • moderate or severe pulmonary hypertension with pulmonary artery systolic pressure \>35 mmHg;
• • severe disorders of blood coagulation system/ coagulopathy;
• • fever; active infective endocarditis; active COVID-19 infection; any active or severe chronic viral infections; sepsis;
• • HIV infection: CDC acute retroviral syndrome/ acute HIV infection, CDC stage 3/ WHO stage 4 (AIDS; the CD4+ cell count is less than 200 or the percent of CD4+ cells is less than 15% of all lymphocytes); however, the subjects of the HIVE trial (NCT04810364) are allowed, but with chronic HIV infection (CDC stages 1, 2/ WHO stages 1, 2, 3) only;
• • tuberculosis;
• • creatinine clearance with GFR of \<45 mL/min/1.73 m2 (severe CKD, G3b-G4-G5) by CKD-EPI (2009) or \<45 mL/min by Cockroft-Gault (1976); a few reasons are there for these limitations, a) many medications are contraindicated and/ or dosages must be decreased in patients with severe CKD, b) already-in-use metformin with eGFR ≥45 mL/min/1.73 m2 is not an exclusion criterion, and metformin must be not stopped at the time of or before studies with IV contrast or withheld for 48 hours after the procedure, c) to reduce contrast material and radiation dose and therefore to prevent contrast-associated acute kidney injury, all the procedures with intravascular contrast (CCTA, CMR, SPECT, coronary angiography and any related invasive intravascular procedures) cannot be performed altogether subsequently during 24-48 hours, but it must undergo within two weeks with the recommended minimum break time between procedures of 48 hours and proper preventive hydration of the recruited patients.
• • need for dialysis;
• • liver cirrhosis;
• • severe endocrine disorders (diabetes is permitted) including pre-existing thyroid diseases unless allowed by the Heart Team, or the IRB, or the DSMB;
• • patient has a known hypersensitivity, allergy, or contraindication to any of the following: aspirin, heparin, clopidogrel, and ticlopidine, or to contrast (including iodine and gadolinium) that cannot be adequately pre-medicated;
• • severe asthma or chronic obstructive pulmonary disease with FEV-1 below 50%;
• • patient has other severe medical illness or recent history of substance abuse that may cause non-compliance; confound the data interpretation or is associated with an anticipated limited life expectancy of less than one year;
• • stage IV cancer;
• • patient on the transplant waiting list;
• • moderate and severe anemia with hemoglobin below 11.0 g/dL, any severe blood diseases;
• • acute or recent history of gastrointestinal bleeding;
• • pregnancy;
• • stroke or CVA within three months before admission to the Chest Pain Center;
• • mental diseases, claustrophobia, inability for patient cooperation;
• • prior participation in this study or patient is currently enrolled in another investigational use device, imaging, or drug study that has not been reached its primary endpoint.