coronary intravascuLar UltraSound for CAlcified Nodule

JRCT ID: jRCT1050240037

Registered date:17/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Coronary artery disease
• Date of first enrollment: 20/04/2022
• Target sample size: 1000
• Study type: Observational

Outcome(s)

• Primary Outcome: Incidence of cardiovascular events (cardiac death, non-cardiac death, acute myocardial infarction, unstable angina, revascularization procedures, stroke, peripheral arterial disease, subclavian artery stenosis, aneurysm, valve disease, heart failure, bleeding)

Secondary Outcome

1) Frequency of use of guideline-recommended drug therapy (antiplatelet agents, anticoagulants, beta-blockers, ACEI inhibitors, ARBs, statins, ezetimibe, PCSK9 inhibitors, EPA/DHA preparations, fibrates, amiodarone, aldosterone receptor antagonists, DPP-4 inhibitors, GLP1 preparations, SGLT2 inhibitors, metformin, insulin)
2) Blood pressure, lipid, blood glucose, renal function, and anemia index values under drug therapy
3) Myocardial infarction severity (Killip classification, CPK, CPK-MB, troponin T, left ventricular ejection fraction)
4) Guideline-recommended revascularization procedures (PCI, CABG, peripheral vascular intervention, carotid artery bypass, aortic aneurysm replacement, stent use, stent type)
5) Coronary artery stenosis index (number of branches, degree of stenosis, lesion length, presence of calcification, bifurcation lesion, chronic total occlusive lesion, occlusion of coronary artery bypass vessel)
6) Plaque index evaluated by intracoronary imaging
7) Coronary plaque index measured by MRI
8) Coronary circulatory physiological indices before and after revascularization (myocardial blood flow reserve ratio (FFR), coronary flow reserve (CFR), resting physiological blood flow indices (iFR, RFR, dPR, DFR))
9) Plaque findings observed on coronary CT
10) Blood flow analysis indices for CT, MRI, and echocardiography
11) Myocardial ischemia index evaluated by cardiac nuclear medicine examination

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable

Include criteria

Refractory severe coronary artery disease
Furthermore, Patients with coronary artery disease should have one of the following conditions
High risk of cardiovascular events (familial hypercholesterolemia, cardiogenic shock, stenting requiring revascularization, complicated revascularization, chronic kidney disease requiring maintenance dialysis, coronary artery disease caused by calcified nodules, high risk of bleeding, elderly patients over 80 years, left main trunk stenosis)
High risk of restenosis (restenosis more than twice, restenosis causing myocardial infarction, restenosis within one year, and lesion with calcification)
Non atherosclerotic coronary artery disease (coronary artery embolism, coronary artery ectasia, spontaneous coronary artery dissection)
Subclavian artery steal syndrome
Patients with coronary artery bypass surgery
Patients with comorbidities other than coronary artery disease (peripheral vascular disease, collagen disease, inflammatory disease, chronic obstructive pulmonary disease, congenital heart disease, pulmonary hypertension, aortic dissection, apical ballooning, cerebral infarction)

• Exclude criteria: Patients deemed inappropriate by the Principal Investigator/Associate Investigator

Related Information

• Primary Sponsor: Kataoka Yu