OCT Versus Angiography for Culprit Lesion Revascularization in Acute Myocardial Infarction PatiEnts (FRAME-AMI3)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Myocardial Infarction; ST Elevation Myocardial Infarction
• Intervention / Treatment: Procedure: Angiography-guided PCI group; Procedure: Optical coherence tomography-guided PCI group

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.

• Study Type: Interventional
• Enrollment (Estimated): 1500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Seung Hun Lee, MD, PhD; Phone Number: 82-2-220-6246; Email: lsh8602@naver.com
• Study Contact Backup: Name: Young Joon Hong, MD, PhD; Phone Number: 82-2-220-5778; Email: hyj200@hanmail.net

Study Locations

• Korea, Republic of
  • Gwangju, Korea, Republic of, 61469
    • Recruiting
    • Chonnam National University
    • Contact: Seung Hun Lee, MD, PhD; Email: lsh8602@naver.com
    • Sub-Investigator: Seung Hun Lee, MD, PhD
    • Contact: Young Joon Hong, MD, PhD; Email: hyj200@hanmail.net
    • Principal Investigator: Young Joon Hong, MD, PhD
    • Sub-Investigator: Min Chul Kim, MD, PhD
    • Sub-Investigator: Joon Ho Ahn, MD, PhD
  • Seoul, Korea, Republic of, 06351
    • Not yet recruiting
    • Samsung Medical Center
    • Principal Investigator: Joo-Yong Hahn, MD, PhD
    • Sub-Investigator: Joo Myung Lee, MD, MPH, PhD
    • Contact: Joo-Yong Hahn, MD, PhD; Email: jooyong.hahn@gmail.com
    • Contact: Joo Myung Lee, MD, MPH, PhD; Email: drone80@hanmal.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Angiography-guided PCI; The PCI procedure in this group will be performed as standard procedure.	Procedure: Angiography-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.
Experimental: Optical coherence tomography-guided PCI; Use of OCT will be allowed at any step of PCI (pre-PCI, during PCI and post-PCI), but OCT after stent implantation will be mandatory. In this group, the recommendations for selecting reference segment, selecting appropriate size of stent, and stent optimization are as follows. OPTIS imaging catheter (Abbott Vascular) will be used for the imaging arm according to MLD MAX algorithm.	Procedure: Optical coherence tomography-guided PCI group; [Stent Optimization]; 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 mm2② In LM lesion: MSA>7 mm2 for distal LM and >8 mm2 for proximal LM; 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; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target vessel failure	a composite of cardiac death, target-vessel myocardial infarction, clinically-driven target-vessel repeat revascularization, definite or probable stent thrombosis	2 years after last patient enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause death	All-cause death	2 years after last patient enrollment
Cardiac death	Cardiac death	2 years after last patient enrollment
Incidence of contrast-induced nephropathy	Incidence of contrast-induced nephropathy, defined as an increase in serum creatinine of ≥0.5mg/dL or ≥25% from baseline within 48-72 hours after contrast agent exposure.	at least 1 week after index procedure
Rate of any myocardial infarction	Any myocardial infarction, defined by Forth Universal definition of myocardial infarction	2 years after last patient enrollment
Rate of spontaneous myocardial infarction	Spontaneous myocardial infarction, defined by Forth Universal definition of myocardial infarction	2 years after last patient enrollment
Rate of procedure-related myocardial infarction	Procedure-related myocardial infarction, defined by ARC II definition	2 years after last patient enrollment
Rate of any revascularization	Any revascularization (clinically-driven or ischemia-driven)	2 years after last patient enrollment
Rate of target vessel revascularization	Target vessel revascularization	2 years after last patient enrollment
Rate of stent thrombosis	Definite or probable stent thrombosis, defined by ARC II definition	2 years after last patient enrollment
Total procedural time	Total procedural time (primary PCI to end of the procedure including amount of staged procedure)	at least 1 week after index procedure
Total fluoroscopy time	Total fluoroscopy time (primary PCI to end of the procedure including amount of staged procedure)	at least 1 week after index procedure
Total amount of contrast use	Total amount of contrast use (primary PCI to end of the procedure including amount of staged procedure)	at least 1 week after index procedure

Collaborators and Investigators

• Sponsor: Chonnam National University Hospital
• Collaborators: Samsung Medical Center
• Investigators: Principal Investigator: Young Joon Hong, MD, PhD, Chonnam National University; Principal Investigator: Joo-Yong Hahn, MD, PhD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: December 31, 2023
• First Submitted That Met QC Criteria: January 18, 2024
• First Posted (Actual): January 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Optical coherence tomography; Primary PCI; Intravascular imaging; ST-segment elevation MI
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction
• Other Study ID Numbers: FRAMEAMI220716

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After publication of main paper, de-identified data will be shared upon reasonable requests after discussion by Executive Committee.
• IPD Sharing Time Frame: After publication of main paper.
• IPD Sharing Access Criteria: Executive Committee will discuss to share the de-identified data upon reasonable requests.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No