Comparing imaging-guided and angiography-guided procedures for heart stent placement
Concurrent OPTIcal Coherence Tomography and frActional Flow REserve-guided Therapeutic Intervention in Patients With Coronary Artery Disease (OPTICARE-CAD)
This study is testing whether using a new imaging method along with standard techniques can help people with coronary artery disease have better results when getting heart stents placed.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 700 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Korea University Guro Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06182683 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of using both optical coherence tomography (OCT) and fractional flow reserve (FFR) in guiding percutaneous coronary interventions (PCI) for patients with coronary artery disease. Participants will be randomly assigned to receive either the combined imaging approach or the conventional angiography-guided method during their stent implantation procedures. The study seeks to determine if the concurrent use of OCT and FFR leads to better clinical outcomes compared to traditional methods. By comparing these two strategies, the trial hopes to provide insights into optimizing treatment for coronary artery disease.
Who should consider this trial
Good fit: Ideal candidates include adults over 19 years old who are undergoing coronary stent implantation for stable angina or acute coronary syndrome.
Not a fit: Patients with a history of bleeding disorders, severe cardiogenic shock, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment outcomes for patients undergoing stent placement for coronary artery disease.
How similar studies have performed: While various studies have explored imaging-guided PCI, this specific combination of OCT and FFR has not been previously tested, making this approach novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age greater than 19 years old 2. Patients undergoing coronary stent implantation for stable angina or acute coronary syndrome 3. Patients provided on informed consent Exclusion Criteria: 1. Individuals with a history of increased bleeding tendencies or hematologic disorders 2. Presented with refractory cardiogenic shock 3. Individuals with a history of stent thrombosis 4. Expected life expectancy of less than 1 year 5. Left ventricular ejection fraction (LVEF) ≥ 20% 6. Women who are breastfeeding, pregnant, or planning to become pregnant 7. Deemed unsuitable for participation by the investigator 8. Patients unwilling to participate in the clinical trial
Where this trial is running
Seoul
- Korea University Guro Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Dong Oh Kang, MD, PhD — Korea University Guro Hospital
- Study coordinator: Dong Oh Kang, MD, PhD
- Email: gelly9@naver.com
- Phone: 82-2-2626-3184
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.