Evaluating AI technologies for coronary artery disease treatment
Influence of Novel Intravascular Ultrasound-Based Artificial Intelligence Technologies on Event Reduction Following Percutaneous Coronary Intervention (INNOVATE-PCI)
Asan Medical Center · NCT05807841
This study is testing if AI tools can help doctors better predict outcomes for patients with coronary artery disease who are getting stents placed in their arteries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Asan Medical Center (other) |
| Locations | 16 sites (Bucheon-si and 15 other locations) |
| Trial ID | NCT05807841 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include symptomatic angina patients aged 19 or older with at least one coronary artery requiring stent implantation.
Not a fit: Patients with severe conditions such as ST-segment elevation myocardial infarction or those with a life expectancy of less than two years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance decision-making and improve outcomes for patients undergoing PCI.
How similar studies have performed: Other studies utilizing machine learning in cardiovascular interventions have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Bucheon-si and 15 other locations
- 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)
- The Catholic university of korea, daejeon st. mary's hospital — Daejeon, South Korea (RECRUITING)
- Gangneung Asan Hospital — Gangneung, South Korea (RECRUITING)
- Jesushospital — Jeonju, South Korea (RECRUITING)
- Chungnam National University Sejong Hospital — Sejong, South Korea (RECRUITING)
- Seung-Whan Lee — Seoul, South Korea (RECRUITING)
- Kangbuk Samsung Medical Center — Seoul, South Korea (NOT_YET_RECRUITING)
- The Catholic university of korea, Eunpyeong st. mary's hospital — Seoul, South Korea (RECRUITING)
- Veterans Hospital Service Medical Center — Seoul, South Korea (RECRUITING)
- The Catholic University of Korea ST.VINCENT'S Hospital — Suwon, South Korea (RECRUITING)
- Ulsan University Hospital — Ulsan, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Coronary Artery Disease, percutaneous coronary intervention, artificial intelligence, machine learning, intravascular ultrasound, coronary angiography