OCT Versus Angiography for Culprit Lesion Revascularization in Acute Myocardial Infarction PatiEnts
NCT ID: NCT06227754
Last Updated: 2025-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1500 participants
INTERVENTIONAL
2024-03-25
2029-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Angiography-guided PCI
The PCI procedure in this group will be performed as standard 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.
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.
Optical 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)
Interventions
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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.
Optical 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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Chonnam National University Hospital
OTHER
Responsible Party
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Young Joon Hong
Professor
Principal Investigators
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Young Joon Hong, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Chonnam National University
Joo-Yong Hahn, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Locations
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Dong-A University College of Medicine
Busan, , South Korea
Kosin University Gospel Hospital
Busan, , South Korea
Kyungpook National University Hospital
Daegu, , South Korea
Yeungnam University Medical Center
Daegu, , South Korea
Daegu Catholic University Medical Center
Daegu, , South Korea
Chonnam National University
Gwangju, , South Korea
Wonkwang University Hospital
Iksan, , South Korea
International St. Mary's Hospital
Incheon, , South Korea
Jeju National University Hospital
Jeju City, , South Korea
Jeonbuk National University Hospital
Jeonju, , South Korea
Gyeongsang National University Hospital
Jinju, , South Korea
Kyung Hee University Hospital
Seoul, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Chung-Ang University Hospital
Seoul, , South Korea
Ewha Womans University Seoul Hospital
Seoul, , South Korea
Ewha Womans University Mokdong Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
St. Carollo Hospital
Suncheon, , South Korea
Uijeongbu St Mary's Hospital
Uijeongbu-si, , South Korea
Ulsan University Hospital
Ulsan, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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FRAMEAMI220716
Identifier Type: -
Identifier Source: org_study_id
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