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
1 other identifier
interventional
1,500
1 country
21
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2024
Longer than P75 for not_applicable
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 31, 2023
CompletedFirst Posted
Study publicly available on registry
January 29, 2024
CompletedStudy Start
First participant enrolled
March 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
September 9, 2025
September 1, 2025
4.8 years
December 31, 2023
September 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (12)
All-cause death
2 years after last patient enrollment
Cardiac death
2 years after last patient enrollment
Rate of any myocardial infarction
2 years after last patient enrollment
Rate of spontaneous myocardial infarction
2 years after last patient enrollment
Rate of procedure-related myocardial infarction
2 years after last patient enrollment
- +7 more secondary outcomes
Study Arms (2)
Angiography-guided PCI
ACTIVE COMPARATORThe PCI procedure in this group will be performed as standard procedure.
Optical coherence tomography-guided PCI
EXPERIMENTALUse 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.
Interventions
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.
\[Stent Optimization\] 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
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chonnam National University Hospitallead
- Samsung Medical Centercollaborator
Study Sites (21)
Dong-A University College of Medicine
Busan, 49241, South Korea
Kosin University Gospel Hospital
Busan, 49266, South Korea
Kyungpook National University Hospital
Daegu, 41944, South Korea
Yeungnam University Medical Center
Daegu, 42415, South Korea
Daegu Catholic University Medical Center
Daegu, 42472, South Korea
Chonnam National University
Gwangju, 61469, South Korea
Wonkwang University Hospital
Iksan, 54538, South Korea
International St. Mary's Hospital
Incheon, 22711, South Korea
Jeju National University Hospital
Jeju City, 63241, South Korea
Jeonbuk National University Hospital
Jeonju, 54907, South Korea
Gyeongsang National University Hospital
Jinju, 52727, South Korea
Kyung Hee University Hospital
Seoul, 02447, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Chung-Ang University Hospital
Seoul, 06973, South Korea
Ewha Womans University Seoul Hospital
Seoul, 07804, South Korea
Ewha Womans University Mokdong Hospital
Seoul, 07985, South Korea
Korea University Guro Hospital
Seoul, 08308, South Korea
St. Carollo Hospital
Suncheon, 57931, South Korea
Uijeongbu St Mary's Hospital
Uijeongbu-si, 11765, South Korea
Ulsan University Hospital
Ulsan, 44033, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Young Joon Hong, MD, PhD
Chonnam National University
- PRINCIPAL INVESTIGATOR
Joo-Yong Hahn, MD, PhD
Samsung Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 31, 2023
First Posted
January 29, 2024
Study Start
March 25, 2024
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2029
Last Updated
September 9, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- After publication of main paper.
- Access Criteria
- Executive Committee will discuss to share the de-identified data upon reasonable requests.
After publication of main paper, de-identified data will be shared upon reasonable requests after discussion by Executive Committee.