Evaluating AI technologies for coronary artery disease treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to validate the diagnostic performance and clinical impact of machine learning algorithms based on coronary angiography and intravascular ultrasound (IVUS) in patients with coronary artery disease. Conducted across 15 centers in South Korea, the study will enroll 3,000 patients undergoing percutaneous coronary intervention (PCI) from January 2020 to June 2025. The study will assess the effectiveness of these AI models in predicting outcomes related to stent optimization and target vessel failure over a two-year period. Both treated and deferred lesions will be evaluated to understand the algorithms' prognostic capabilities.

Why it matters

Who can join: the full rules

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 exclusion Criteria:

* Left main culprit lesion (angiographic diameter stenosis \>50%)
* Thrombus-containing lesion
* In-stent restenosis
* Side branch lesion
* Chronic total occlusion
* Small vessel with reference diameter \<2.5mm
* Coronary spasm despite administration of nitrate
* Inability for imaging catheter to pass through tight stenosis, calcification, angulations
* Poor image quality
* Angiographically visible collateral vessels

Where it's running

• Soon Chun Hyang University Hospital Bucheon
  Bucheon-si, South Korea Recruiting
• Gosin University Gospel Hospital
  Busan, South Korea Recruiting
• Inje University Pusan Paik Hospital
  Busan, South Korea Recruiting
• Gyeongsang National University Changwon Hospital
  Changwon, South Korea Recruiting
• Kangwon National University Hospital
  Chuncheon, South Korea Recruiting
• Keimyung University Dongsan Medical Center
  Daegu, South Korea Recruiting

Study contacts

• Principal investigator: Seung-Whan Lee, MD — Asan Medical Center
• Study coordinator: Seung-Whan Lee, MD
• Email: seungwlee@amc.seoul.kr
• Phone: 82-10-7398-9897

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.