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ST Elevation Myocardial InfarctionFRAME-AMI3NCT06227754

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

A study testing Angiography-guided PCI group and Optical coherence tomography-guided PCI group in people with ST Elevation Myocardial Infarction and Myocardial Infarction, run by Chonnam National University Hospital at 18 sites in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Angiography-guided PCI group and Optical coherence tomography-guided PCI group
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,500 participants
Where
18 sitesSouth Korea
Study dates
25 Mar 2024to 31 Dec 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
Show all 9Show fewer
  • 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

Trial locations and contacts

18 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Seung Hun Lee, MD, PhD contact

82-2-220-6246

lsh8602@naver.com

Young Joon Hong, MD, PhD contact

82-2-220-5778

hyj200@hanmail.net

18 sites in 1 country

South Korea18 sites, 18 recruiting
  • Kyungpook National University Hospital

    Daegu, Daegu, 41944

    Nam Kyun Kim, MD, PhD, namkyun.kim@knu.ac.kr

    Nam Kyun Kim, MD, PhD

    Recruiting
  • Yeungnam University Medical Center

    Daegu, Daegu, 42415

    Ung Kim, MD, PhD, woongwa@gmail.com

    Ung Kim, MD, PhD

    Recruiting
  • Daegu Catholic University Medical Center

    Daegu, Daegu, 42472

    Jin Bae Lee, MD, PhD, noblewise1@gmail.com

    Jin Bae Lee, MD, PhD

    Recruiting
  • Chonnam National University

    Gwangju, Gwangju, 61469

    Young Joon Hong, MD, PhD, hyj200@hanmail.net

    Seung Hun Lee, MD, PhD, lsh8602@naver.com

    Recruiting
  • Wonkwang University Hospital

    Iksan, Iksan, 54538

    Donghyeon Joo, MD, dhjoozz@naver.com

    Kyeong Ho Yun, MD, PhD

    Recruiting
  • International St. Mary's Hospital

    Incheon, Incheon, 22711

    Hyung-Bok Park, MD, PhD, hyungbok7@gmail.com

    Hyung-Bok Park, MD, PhD

    Recruiting
  • Jeju National University Hospital

    Jeju City, Jeju-do, 63241

    Song-Yi Kim, MD, PhD, ttoromom@jejunu.ac.kr

    Song-Yi Kim, MD, PhD

    Recruiting
  • Jeonbuk National University Hospital

    Jeonju, Jeonju, 54907

    Yi Sik Kim, MD, PhD, dr.kimesik@gmail.com

    Sang-Rok Lee, MD, PhD

    Recruiting
  • Gyeongsang National University Hospital

    Jinju, Jinju, 52727

    Jin-Sin Koh, MD, PhD, kjs0175@gmail.com

    Jin-Sin Koh, MD, PhD

    Recruiting
  • Kyung Hee University Hospital

    Seoul, Seoul, 02447

    Weon Kim, MD, PhD, mylovekw@hanmail.net

    Weon Kim, MD, PhD

    Recruiting
  • Samsung Medical Center

    Seoul, Seoul, 06351

    Joo-Yong Hahn, MD, PhD, jooyong.hahn@gmail.com

    Joo Myung Lee, MD, MPH, PhD, drone80@hanmal.net

    Recruiting
  • Chung-Ang University Hospital

    Seoul, Seoul, 06973

    Wang Soo Lee, MD, PhD, wslee1227@cau.ac.kr

    Wang Soo Lee, MD, PhD

    Recruiting
  • Ewha Womans University Seoul Hospital

    Seoul, Seoul, 07804

    Sanghoon Shin, MD, PhD, nephilla99@gmail.com

    Sanghoon Shin, MD, PhD

    Recruiting
  • Ewha Womans University Mokdong Hospital

    Seoul, Seoul, 07985

    Sodam Jung, MD, PhD, cvdosam@gmail.com

    Sodam Jung, MD, PhD

    Recruiting
  • Korea University Guro Hospital

    Seoul, Seoul, 08308

    Dong Oh Kang, MD, PhD, gelly9@naver.com

    Dong Oh Kang, MD, PhD

    Recruiting
  • St. Carollo Hospital

    Suncheon, Suncheon, 57931

    Jang Hyun Cho, MD, PhD, goodnew8@naver.com

    Jang Hyun Cho, MD, PhD

    Recruiting
  • Uijeongbu St Mary's Hospital

    Uijeongbu-si, Uijeongbu, 11765

    Chan Joon Kim, MD, PhD, godandsci@naver.com

    Chan Joon Kim, MD, PhD

    Recruiting
  • Ulsan University Hospital

    Ulsan, Ulsan, 44033

    Eun Seok Shin, MD, PhD, sesim1989@gmail.com

    Eun Seok Shin, MD, PhD

    Recruiting

Other trials in South Korea

About this study

Official title: 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).

Read the 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.

Being tested
Angiography-guided PCI group, Optical coherence tomography-guided PCI group
Keywords
ST-segment elevation MI, Optical coherence tomography, Intravascular imaging, Primary PCI
Medical subject headings
ST Elevation Myocardial Infarction, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Angiography-guided PCI groupProcedure or surgery

    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 groupProcedure or surgery

    [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)

Study groups in NCT06227754
Study groupRoleWhat they receive
Angiography-guided PCIActive comparatorThe PCI procedure in this group will be performed as standard procedure.
Receives: Procedure: Angiography-guided PCI group
Optical coherence tomography-guided PCIExperimentalUse 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.
Receives: Procedure: Optical coherence tomography-guided PCI group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Target vessel failure

    a composite of cardiac death, target-vessel myocardial infarction, clinically-driven target-vessel repeat revascularization, definite or probable stent thrombosis

    Measured: 2 years after last patient enrollment

Secondary outcomes (12)
  1. All-cause death

    All-cause death

    Measured: 2 years after last patient enrollment

  2. Cardiac death

    Cardiac death

    Measured: 2 years after last patient enrollment

  3. Rate of any myocardial infarction

    Any myocardial infarction, defined by Forth Universal definition of myocardial infarction

    Measured: 2 years after last patient enrollment

  4. Rate of spontaneous myocardial infarction

    Spontaneous myocardial infarction, defined by Forth Universal definition of myocardial infarction

    Measured: 2 years after last patient enrollment

  5. Rate of procedure-related myocardial infarction

    Procedure-related myocardial infarction, defined by ARC II definition

    Measured: 2 years after last patient enrollment

  6. Rate of any revascularization

    Any revascularization (clinically-driven or ischemia-driven)

    Measured: 2 years after last patient enrollment

  7. Rate of target vessel revascularization

    Target vessel revascularization

    Measured: 2 years after last patient enrollment

  8. Rate of stent thrombosis

    Definite or probable stent thrombosis, defined by ARC II definition

    Measured: 2 years after last patient enrollment

  9. Total procedural time

    Total procedural time (primary PCI to end of the procedure including amount of staged procedure)

    Measured: at least 1 week after index procedure

  10. Total fluoroscopy time

    Total fluoroscopy time (primary PCI to end of the procedure including amount of staged procedure)

    Measured: at least 1 week after index procedure

  11. Total amount of contrast use

    Total amount of contrast use (primary PCI to end of the procedure including amount of staged procedure)

    Measured: at least 1 week after index procedure

  12. 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.

    Measured: at least 1 week after index procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2024
  2. Study start25 Mar 2024
  3. Primary completion31 Mar 2031 (estimated)
  4. Study completion31 Dec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06227754
Sponsor's protocol ID
FRAMEAMI220716
Acronym
FRAME-AMI3
Status last verified
May 2026
First submitted
31 Dec 2023
Last updated
8 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: After publication of main paper, de-identified data will be shared upon reasonable requests after discussion by Executive Committee.

Questions about this trial

What is this clinical trial studying?

A study testing Angiography-guided PCI group and Optical coherence tomography-guided PCI group in people with ST Elevation Myocardial Infarction and Myocardial Infarction, run by Chonnam National University Hospital at 18 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Seung Hun Lee, MD, PhD (82-2-220-6246, lsh8602@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target vessel failure (time frame: 2 years after last patient enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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