Clinical trial NCT06227754: OCT Versus Angiography for Culprit Lesion Revascularization in Acute Myocardial Infarction PatiEnts
Official title: Randomized Controlled Trial of Optical Coherence Tomography Versus Angiography for Culprit Lesion Revascularization in Patients With Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ST Elevation Myocardial Infarction
Myocardial Infarction
Keywords: ST-segment elevation MI
Optical coherence tomography
Intravascular imaging
Primary PCI
Lead sponsor: Chonnam National University Hospital
Sponsor class: OTHER
Collaborators: name: Samsung Medical Center
First posted: 2024-01-29
Enrollment: 1500
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, multicenter, open-label, randomized controlled trial to compare clinical outcomes between optical coherence tomography (OCT)-guided versus angiography-guided PCI in AMI patients undergoing PCI.
Primary purpose: TREATMENT

Brief 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).

Detailed description: Percutaneous coronary intervention (PCI) is a standard treatment for significantly stenotic lesion of coronary arteries, especially in the setting of acute myocardial infarction (AMI) where timely reperfusion is important. Traditionally, visual assessment by coronary angiography has been the main tool to identify coronary artery disease and guide revascularization. However, it is known that angiography alone is unable to adequately evaluate significance of stenotic lesion or optimization status of the stent, and that angiography suffers from high intra- and interobserver variability. Thus, methods for intracoronary imaging and/or physiology have been developed to aid these limitations.

During the PCI procedure, intravascular imaging devices such as intravascular ultrasound (IVUS) and optical coherence tomography (OCT) are useful tools for providing information on lesion characteristics and optimal stent implantation with regard to appropriate reference segment, stent expansion, stent apposition, and possible acute complications. Therefore, intravascular imaging guidance may improve clinical outcomes after complex PCI. However, although previous randomized controlled trial and registries showed significantly lower rates of major adverse clinical events following IVUS-guided PCI compared with angiography-guided PCI, the randomized controlled trials were limited with small sample size and dealt with very selected lesion subsets such as chronic total occlusion (CTO) or long lesions. Moreover, although some studies observed similar clinical outcomes between IVUS-guided PCI and OCT-guided PCI, it is uncertain whether OCT-guided PCI improves clinical outcomes compared with angiography-guided PCI.

Currently, randomized controlled trial to support beneficial impact of OCT-guided PCI, especially in patients with acute myocardial infarction (AMI) is lacking. One randomized clinical trial in 2016 with 240 non-ST-elevation myocardial infarction patients have reported higher postprocedural fractional flow reserve and similar incidence of major adverse cardiac events with the use of OCT compared to angiography alone, but this study mostly focused on immediate physiologic findings of OCT-guided PCI and only demonstrated clinical outcomes on short-term follow-up. Although the ILUMIEN IV trial evaluated efficacy of OCT-guided PCI among high risk patients including lesions were considered to be responsible for a recent myocardial infarction, there was no apparent difference in the target-vessel failure at 2 years. There is no randomized controlled trial that can provide information on its long-term clinical impact, and current clinical guidelines puts OCT on Class 2a recommendation as an alternative for IVUS, with the exception of ostial left main disease.

In this regard, randomized controlled trial comparing clinical outcome following PCI in patients with AMI where procedural optimization is performed under OCT-guidance or angiography alone would provide valuable evidence to enhance prognosis after treatment of AMI. Therefore, FRAME-AMI 3 trial has been designed to compare clinical outcomes after PCI for infarct-related artery using either OCT-guided or angiography-guided strategy.

Eligibility 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

Primary outcomes:
measure: Target vessel failure
timeFrame: 2 years after last patient enrollment
Secondary outcomes:
measure: All-cause death
timeFrame: 2 years after last patient enrollment
measure: Cardiac death
timeFrame: 2 years after last patient enrollment
measure: Rate of any myocardial infarction
timeFrame: 2 years after last patient enrollment
measure: Rate of spontaneous myocardial infarction
timeFrame: 2 years after last patient enrollment
measure: Rate of procedure-related myocardial infarction
timeFrame: 2 years after last patient enrollment
measure: Rate of any revascularization
timeFrame: 2 years after last patient enrollment
measure: Rate of target vessel revascularization
timeFrame: 2 years after last patient enrollment
measure: Rate of stent thrombosis
timeFrame: 2 years after last patient enrollment
measure: Total procedural time
timeFrame: at least 1 week after index procedure
measure: Total fluoroscopy time
timeFrame: at least 1 week after index procedure
measure: Total amount of contrast use
timeFrame: at least 1 week after index procedure
measure: Incidence of contrast-induced nephropathy
timeFrame: at least 1 week after index procedure
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Chonnam National University
name: Young Joon Hong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Joo-Yong Hahn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: