RecruitingNot ApplicableNCT06227754

OCT Versus Angiography for Culprit Lesion Revascularization in Acute Myocardial Infarction PatiEnts

Randomized Controlled Trial of Optical Coherence Tomography Versus Angiography for Culprit Lesion Revascularization in Patients With Acute Myocardial Infarction


Sponsor

Chonnam National University Hospital

Enrollment

1,500 participants

Start Date

Mar 25, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of the study is to compare clinical outcomes between optical coherence tomography-guided versus angiography-guided percutaneous coronary intervention (PCI) in patients with acute myocardial infarction (AMI).


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Angiography-guided PCI group and a procedure called Optical coherence tomography-guided PCI group for people with myocardial infarction and st elevation myocardial infarction. The study is currently recruiting participants at 18 locations. People eligible for this study include aged 19 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREAngiography-guided PCI group

The PCI procedure in this group will be performed as standard procedure. After deployment of stent, stent optimization will be done based on angiographic findings. The optimization guided by angiography should meet the criteria of angiographic residual diameter stenosis less than 10% by visual estimation and the absence of flow limiting dissection (≥Type C dissection). When angiographic under-expansion of the stent is suspected, adjunctive balloon dilatation will be strongly recommended.

PROCEDUREOptical coherence tomography-guided PCI group

\[Stent Optimization\] 1. Stent Expansion: Visually assess residual angiographic diameter stenosis \<10% "AND" ① In non-LM lesions: In-stent minimal lumen area (MSA) \>80% of the average reference lumen area "OR" \>4.5 mm2 ② In LM lesion: MSA\>7 mm2 for distal LM and \>8 mm2 for proximal LM 2. Stent Apposition: No major malapposition (defined as a distance from stent strut to adjacent intima ≥400 um and \< 1mm length) of the stent over its entire length against the vessel wall 3. Edge Dissection: No major edge dissection in the proximal or distal reference segments, defined as 5 mm from the edge of the stent, extended to media layer with potential to provoke flow disturbances (defined as \>60° of the circumference of the vessel at site of dissection and/or \>2 mm in length of dissection flap)


Locations(18)

Kyungpook National University Hospital

Daegu, Daegu, South Korea

Yeungnam University Medical Center

Daegu, Daegu, South Korea

Daegu Catholic University Medical Center

Daegu, Daegu, South Korea

Chonnam National University

Gwangju, Gwangju, South Korea

Wonkwang University Hospital

Iksan, Iksan, South Korea

International St. Mary's Hospital

Incheon, Incheon, South Korea

Jeju National University Hospital

Jeju City, Jeju-do, South Korea

Jeonbuk National University Hospital

Jeonju, Jeonju, South Korea

Gyeongsang National University Hospital

Jinju, Jinju, South Korea

Kyung Hee University Hospital

Seoul, Seoul, South Korea

Samsung Medical Center

Seoul, Seoul, South Korea

Chung-Ang University Hospital

Seoul, Seoul, South Korea

Ewha Womans University Seoul Hospital

Seoul, Seoul, South Korea

Ewha Womans University Mokdong Hospital

Seoul, Seoul, South Korea

Korea University Guro Hospital

Seoul, Seoul, South Korea

St. Carollo Hospital

Suncheon, Suncheon, South Korea

Uijeongbu St Mary's Hospital

Uijeongbu-si, Uijeongbu, South Korea

Ulsan University Hospital

Ulsan, Ulsan, South Korea

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NCT06227754


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