Coronary Artery Disease
Conditions
Keywords
percutaneous coronary intervention, artificial intelligence, machine learning, intravascular ultrasound, coronary angiography
Brief summary
This study is a prospective, multicenter study in the real practice to validate the diagnostic performances and clinical impact of coronary angiography & intravascular ultrasound (IVUS)-based models developed by machine learning (ML).
Detailed description
The aim of the study is to evaluate the performances and prognostic impact of coronary angiography & IVUS-based algorithms for decision making and stent optimization in a multicenter, prospective cohort. Between January 2020 and June 2027, a total of 3,000 patients who performed coronary angiography (± FFR) and have at least one coronary stenosis requiring PCI (as culprit) will be enrolled from 16 centers in South Korea. In addition, the deferred lesions with visual estimated diameter stenosis of \>30% will be evaluated as non-culprits. Brief study design is as depicted in the following figure. Supervised ML algorithms include: 1) angiography- and IVUS-based algorithms for predicting FFR, 2) IVUS-based algorithm for plaque characterization, 3) IVUS-based algorithm for predicting stent expansion, and 4) post-stenting IVUS-based algorithm for predicting stent failure. In the prospective cohort, the performance of each model will be assessed. This registry trial composed of the treated (culprit) and the deferred (nonculprit) coronary lesions has two primary objectives as follow; 1) Primary objectives in treated (culprit) lesions is to see the impact of the integrated ML model on the development of culprit-related 2-year target vessel failure (TVF). 2) Primary objectives in deferred (nonculprit) lesions is to see the impact of the integrated ML model on the development of nonculprit-related 2-year TVF.
Interventions
PROCEDUREpercutaneous coronary intervention
IVUS-guided stent implantation
Sponsors
Asan Medical Center
Boston Scientific Corporation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 19 years or older * Symptomatic angina patients with objective myocardial ischemia * Patients with at least one major epicardial coronary artery that requires stent implantation * Subject who signs with informed consent form Patient
Exclusion criteria
* ST-segment elevation MI at admission * Patients who underwent coronary artery bypass surgery or heart transplantation * Left ventricular ejection fraction \<30% * Cardiogenic shock * Patients whose life expectancy \<2 years * Woman who are breastfeeding, pregnant or planning to become pregnant during study * Patients in whom anti-platelets or heparin is contraindicated Lesion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| culprit-related TVF | 2 years after stent implantation | composite of cardiac death, myocardial infarction (MI), stent thrombosis, and clinically-driven target vessel revascularization (TVR) at 2 years after SynergyTM implantation |
| nonculprit-related TVF | 2 years after stent implantation | composite of cardiac death, MI, and clinically-driven TVR at 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| each component of primary measures | 2 years after stent implantation | each of cardiac death, non-fetal MI, ST and target vessel revascularization |
| all cause death | 2 years after stent implantation | all cause death |
| repeat revascularization | 2 years after stent implantation | repeat revascularization |
| stroke | 2 years after stent implantation | stroke |
| bleeding | 2 years after stent implantation | bleeding |
Countries
South Korea
Contacts
CONTACTSeung-Whan Lee, MD
PRINCIPAL_INVESTIGATORSeung-Whan Lee, MD
Asan Medical Center
Outcome results
None listed