Comparing imaging techniques for heart artery treatment in heart attack patients
Randomized Controlled Trial of Optical Coherence Tomography Versus Angiography for Culprit Lesion Revascularization in Patients With Acute Myocardial Infarction
This study is testing whether using a new imaging technique called optical coherence tomography can help doctors treat heart attack patients better than the traditional method during a procedure to open blocked arteries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1500 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Chonnam National University Hospital Academic / other |
| Locations | 18 sites (Daegu, Daegu and 17 other locations) |
| Trial ID | NCT06227754 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the clinical outcomes of two different imaging techniques—optical coherence tomography (OCT) and traditional angiography—during percutaneous coronary intervention (PCI) in patients experiencing acute myocardial infarction (AMI). The research will involve patients who are undergoing primary PCI within 12 hours of symptom onset, assessing how each imaging method influences the effectiveness of the procedure. By utilizing OCT, the study seeks to provide more detailed information on coronary artery lesions and optimize stent placement, potentially leading to better patient outcomes. The findings could help establish a more effective standard of care for AMI patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 19 and older who are experiencing acute ST-segment elevation myocardial infarction and are eligible for primary PCI.
Not a fit: Patients with target lesions not suitable for PCI or those with severe renal impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved clinical outcomes and reduced adverse events for patients undergoing PCI for acute myocardial infarction.
How similar studies have performed: Previous studies have shown promising results with intravascular imaging techniques like IVUS, but this specific comparison of OCT versus angiography in a broader AMI population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject must be at least 19 years of age * Acute ST-segment elevation myocardial infarction (STEMI) \*STEMI: ST-segment elevation ≥0.1 mV in ≥2 contiguous leads or documented newly developed left bundle-branch block1 * Primary percutaneous coronary intervention (PCI) in \< 12 h after the onset of symptoms for STEMI patients * Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic evaluation and PCI and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure. Exclusion Criteria: * Target lesions not amenable for PCI by operators' decision * Ostial lesions located in left main vessel or right coronary artery (left main body or distal bifurcation lesions can be enrolled by operator's discretion) * Creatinine clearance ≤30 ml/min/1.73 m2 and not on dialysis (chronic dialysis dependent patients are eligible for enrolment regardless of creatinine clearance) * Cardiogenic shock (Killip class IV) at presentation * Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparin, or Everolimus * Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock) * Pregnancy or breast feeding * Non-cardiac co-morbid conditions are present with life expectancy \<2 year or that may result in protocol non-compliance (per site investigator's medical judgment) * Unwillingness or inability to comply with the procedures described in this protocol
Where this trial is running
Daegu, Daegu and 17 other locations
- Kyungpook National University Hospital — Daegu, Daegu, South Korea (Recruiting)
- Yeungnam University Medical Center — Daegu, Daegu, South Korea (Recruiting)
- Daegu Catholic University Medical Center — Daegu, Daegu, South Korea (Recruiting)
- Chonnam National University — Gwangju, Gwangju, South Korea (Recruiting)
- Wonkwang University Hospital — Iksan, Iksan, South Korea (Recruiting)
- International St. Mary's Hospital — Incheon, Incheon, South Korea (Recruiting)
- Jeju National University Hospital — Jeju City, Jeju-do, South Korea (Recruiting)
- Jeonbuk National University Hospital — Jeonju, Jeonju, South Korea (Recruiting)
- Gyeongsang National University Hospital — Jinju, Jinju, South Korea (Recruiting)
- Kyung Hee University Hospital — Seoul, Seoul, South Korea (Recruiting)
- Samsung Medical Center — Seoul, Seoul, South Korea (Recruiting)
- Chung-Ang University Hospital — Seoul, Seoul, South Korea (Recruiting)
- Ewha Womans University Seoul Hospital — Seoul, Seoul, South Korea (Recruiting)
- Ewha Womans University Mokdong Hospital — Seoul, Seoul, South Korea (Recruiting)
- Korea University Guro Hospital — Seoul, Seoul, South Korea (Recruiting)
- St. Carollo Hospital — Suncheon, Suncheon, South Korea (Recruiting)
- Uijeongbu St Mary's Hospital — Uijeongbu-si, Uijeongbu, South Korea (Recruiting)
- Ulsan University Hospital — Ulsan, Ulsan, South Korea (Recruiting)
Study contacts
- Principal investigator: Young Joon Hong, MD, PhD — Chonnam National University
- Study coordinator: Seung Hun Lee, MD, PhD
- Email: lsh8602@naver.com
- Phone: 82-2-220-6246
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.