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coronary intravascuLar UltraSound for CAlcified Nodule

coronary intravascuLar UltraSound for CAlcified Nodule - U-SCAN

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT1050240037
Enrollment
1000
Registered
2024-05-17
Start date
2022-04-20
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary artery disease

Interventions

None listed

Sponsors

Kataoka Yu
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion 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)

Exclusion criteria

Exclusion criteria: Patients deemed inappropriate by the Principal Investigator/Associate Investigator

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Contacts

Public ContactYu Kataoka

National Cerebral and Cardiovascular Center

yu.kataoka@ncvc.go.jp+81-6-6170-1069

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026