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Acute Myocardial InfarctionFRAME-AMINCT02715518

FFR Versus Angiography-Guided Strategy for Management of AMI With Multivessel Disease

A study testing PCI using 2nd generation drug-eluting stent in people with Acute Myocardial Infarction, run by Samsung Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The aim of the study is to compare clinical outcomes following fractional flow reserve (FFR)-guided versus angiography only guided strategy in treatment of non-infarction related artery (non-IRA) stenosis in patients with acute myocardial infarction (AMI) with multivessel disease Prospective, open-label, randomized… Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Acute Myocardial Infarction
What is being tested?
PCI using 2nd generation drug-eluting stent
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,292 participants
Where
1 siteSouth Korea
Study dates
19 Aug 2016to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

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

(1) Inclusion Criteria

  1. Subject must be at least 19 years of age
  2. Acute ST-segment elevation myocardial infarction (STEMI) A. ※ STEMI: "ST-segment elevation ≥0.1 mV in ≥2 contiguous leads B. or documented newly developed left bundle-branch block "
  3. Acute non-ST-segment elevation myocardial infarction (NSTEMI)
  4. ※ NSTEMI: NSTEMI is defined as a combination of criteria with mandated elevation of a cardiac biomarker, preferably high-sensitive cardiac troponin with at least one value above 99th percentile of the upper reference limit and at least one of the following:
  5. Symptoms of ischaemia.
  6. New or presumed new significant ST-T wave changes
  7. Development of pathological Q waves on electrocardiography (ECG).
  8. Imaging evidence of new or presumed new loss of viable myocardium or regional wall motion abnormality.
  9. Intracoronary thrombus detected on angiography.
  10. Primary percutaneous coronary intervention (PCI) in < 12 h after the onset of symptoms for STEMI patients (In case of NSTEMI, PCI should be performed within 72 hours of symptom onset)
  11. Multivessel disease (at least one stenosis of >50% in a non-culprit vessel ≥ 2.0 mm by visual estimation)
  12. 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. (2) Exclusion criteria
  13. Severe stenosis with TIMI flow ≤ II of the non-IRA artery
  14. Unprotected left main coronary artery disease (stenosis > 50% by visual estimation)
  15. Non-IRA stenosis not amenable for PCI treatment by operators' decision)
  16. Chronic total occlusion in non-IRA
  17. Cardiogenic shock (Killip class IV) already at presentation or the completion of IRA PCI
  18. Intolerance to Aspirin, Clopidogrel, Plasugrel, Ticagrelor, Heparin, Bivaluridin, or Everolimus, Zotarolimus
  19. Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock)
  20. Pregnancy or breast feeding
  21. Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
  22. Other primary valvular disease with severe degree: severe mitral regurgitation, mitral stenosis, severe aortic regurgitation, or aortic stenosis
  23. Patients with a history of Coronary Artery Bypass Graft (CABG) or treated with fibrinolytic Therapy
  24. Unwillingness or inability to comply with the procedures described in this protocol.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Samsung Medical Center

    Seoul

Other trials in South Korea

About this study

Official title: Comparison of Clinical Outcomes Between Fractional Flow Reserve-guided Strategy and Angiography-guided Strategy in Treatment of Non-Infarction Related Artery Stenosis in Patients With Acute Myocardial Infarction

The aim of the study is to compare clinical outcomes following fractional flow reserve (FFR)-guided versus angiography only guided strategy in treatment of non-infarction related artery (non-IRA) stenosis in patients with acute myocardial infarction (AMI) with multivessel disease

Prospective, open-label, randomized, multicenter trial to test the clinical outcomes following FFR-guided or angiography-guided strategy in treatment of non-IRA stenosis in patients with acute AMI with multivessel disease.

Read the detailed description

The presence of ischemia is a prerequisite for the improvement of clinical outcomes with percutaneous coronary intervention (PCI). It is well-known that the discrepancy exists between angiographic stenosis severity and the presence of myocardial ischemia. This discrepancy cannot completely overcome with even more precise invasive imaging modalities such as intravascular ultrasound or optical coherence tomography.

Currently, fractional flow reserve (FFR) is regarded as a gold-standard invasive method to define lesion-specific ischemia and FFR-guided PCI has been proven to reduce unnecessary revascularization and to enhance patient's clinical outcomes. Therefore, current guidelines recommend FFR measurement for intermediate coronary stenosis when there is no definite evidence of lesion-specific ischemia.

However, previous evidences which well demonstrated the benefit of FFR-guided strategy were mostly generated from non-acute myocardial infarction patients.1, 3-5 Recently FAMOUS-NAMI trial evaluated 176 patients with acute non-ST elevation myocardial infarction (NSTEMI) with multivessel disease, and demonstrated feasibility of FFR measurement in acute NSTEMI patients and also presented that FFR-guided decision making for non-infarct related artery (IRA) stenosis was significantly reduced unnecessary stent implantation without any difference in major adverse cardiovascular events at 1-year as well as medical cost, compared with angiography-only guided decision making process.

Nevertheless, there have been no evidence in clinical setting of acute myocardial infarction (AMI). Since about 30-50% of patients with AMI possess multivessel disease, the ability to accurately assess the functional significance of non-IRA stenoses at the time of initial primary PCI would potentially facilitate revascularization decisions with potential for health and economic benefit. Moreover, avoiding unnecessary stent implantation for non-IRA stenoses in patients with AMI with multivessel disease would reduce the possibility of stent- or procedure related complications, and enhance long-term prognosis of patients.

Therefore, the FRAME-AMI trial will compare clinical outcomes after index primary PCI between FFR-guided strategy versus angiography only-guided strategy for management of non-IRA stenoses in AMI with multivessel disease patients.

Being tested
PCI using 2nd generation drug-eluting stent
Keywords
Acute ST-segment elevation myocardial infarction, Acute myocardial infarction, Fractional flow reserve, Percutaneous coronary intervention, Multivessel disease, STEMI, NSTEMI
Medical subject headings
ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction

What participants receive

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

  • PCI using 2nd generation drug-eluting stentDevice

    Percutaneous coronary intervention (PCI) using 2nd generation drug-eluting stent for non-IRA stenosis will be decided according to the allocated arms.

    1. FFR-guided strategy arm
    2. Angiography-guided strategy arm
Study groups in NCT02715518
Study groupRoleWhat they receive
FFR-guided strategy armActive comparatorFFR measurement for non-IRA stenosis (>50% visual estimation) will be performed by continuous infusion of adenosine (140~180ug/kg/min) or intracoronary nicorandil (2mg bolus) injection. The FFR ≤ 0.80 will be targeted for PCI using 2nd generation drug-eluting stent. In case of non-IRA stenosis > 90%, we will judge FFR value of ≤ 0.80. The evaluation of non-IRA stenosis by FFR will be recommended to perform during same intervention with primary PCI for IRA. However, exceptions can be made for complex lesions including ACC/AHA classification B2/C lesion where the operator estimates that the revascularization procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a staged procedure during the same hospitalization.
Receives: Device: PCI using 2nd generation drug-eluting stent
Angiography-guided strategy armActive comparatorNon-IRA stenosis with > 50% stenosis will be the target of PCI using 2nd generation drug-eluting stent. As for the angiography-guided strategy arm, PCI for non-IRA stenosis will be recommended during same procedure. However, exceptions can be made for complex lesions including ACC/AHA classification B2/C lesion where the operator estimates that the revascularization procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a staged procedure during the same hospitalization.
Receives: Device: PCI using 2nd generation drug-eluting stent

What is being measured

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

  1. Patient-oriented composite outcome

    a composite of death, myocardial infarction, or repeat revascularization

    Measured: 24 months

Secondary outcomes (15)

  1. All-cause mortality

    All-cause mortality

    Measured: 24 months

  2. Cardiac death

    Cardiac death

    Measured: 24 months

  3. Any myocardial infarction without procedure-related myocardial infarction

    Any myocardial infarction without procedure-related myocardial infarction

    Measured: 24 months

  4. Any myocardial infarction with periprocedural myocardial infarction

    Any myocardial infarction with periprocedural myocardial infarction

    Measured: 24 months

  5. Any revascularization

    ischemia-driven or all

    Measured: 24 months

  6. Infarct-related artery (IRA) repeat revascularization

    ischemia-driven or all

    Measured: 24 months

  7. Non-IRA repeat revascularization

    ischemia-driven or all

    Measured: 24 months

  8. Stent thrombosis

    ARC-defined definite stent thrombosis

    Measured: 24 months

  9. Stroke

    ischemic and hemorrhagic

    Measured: 24 months

  10. Total amount of contrast use

    From primary PCI to end of the procedure including amount of staged procedure

    Measured: 1 week

  11. 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: 3 days

  12. Seattle Angina Questionnaires

    Angina severity

    Measured: 12-month

  13. Seattle Angina Questionnaires

    Angina severity

    Measured: 24-month

  14. All-cause death and myocardial infarction

    A composite of all-cause death and any myocardial infarction (MI) according to the ARC consensus

    Measured: 24-month

  15. Death, spontaneous myocardial infarction, or repeat revascularization

    A composite of Death, spontaneous myocardial infarction, or repeat revascularization

    Measured: 24-month

Timeline

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

  1. First posted22 Mar 2016 (estimated)
  2. Study start19 Aug 2016
  3. Primary completion30 Jun 2022
  4. Study completion31 Dec 2023

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
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
1,292 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02715518
Sponsor's protocol ID
FRAME16453143
Acronym
FRAME-AMI
Status last verified
Apr 2024
First submitted
16 Mar 2016
Last updated
17 Apr 2024
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked

Publications

  • Lee SH, Kim H, Lee JM, Ahn JH, Park S, Lee YK, Joo D, Cho KH, Kim MC, Sim DS, Kim HK, Park KH, Choo EH, Kim CJ, Ahn SG, Doh JH, Lee SY, Park SD, Lee HJ, Kang MG, Nam CW, Hong D, Joh HS, Choi KH, Park TK, Yang JH, Song YB, Choi SH, Kim JH, Ahn Y, Jeong MH, Gwon HC, Hahn JY, Koh JS, Hong YJ; FRAME-AMI Investigators. Clinical Relevance of Fractional Flow Reserve-Guided Percutaneous Coronary Interevention According to Left Ventricular Ejection Fraction in Patients With Acute Myocardial Infarction and Multivessel Disease. J Am Heart Assoc. 2025 Sep 2;14(17):e043414. doi: 10.1161/JAHA.125.043414. Epub 2025 Aug 29.

    PubMed 40878980

  • Lim Y, Jang J, Lee SH, Ahn JH, Hong YJ, Ahn Y, Jeong MH, Kim CJ, Hahn JY, Lee JM, Park KH, Choo EH, Ahn SG, Doh JH, Lee SY, Park SD, Lee HJ, Kang MG, Cho YK, Nam CW, Bu SH, Kim MC. Staged versus immediate complete revascularization for non-culprit arteries in acute myocardial infarction: a post-hoc analysis of FRAME-AMI. Front Cardiovasc Med. 2024 Dec 12;11:1475483. doi: 10.3389/fcvm.2024.1475483. eCollection 2024.

    PubMed 39726942

  • Kwon W, Choi KH, Lee SH, Hong D, Shin D, Kim HK, Park KH, Choo EH, Kim CJ, Kim MC, Hong YJ, Ahn SG, Doh JH, Lee SY, Park SD, Lee HJ, Kang MG, Koh JS, Cho YK, Nam CW, Joh HS, Kyu Park T, Yang JH, Song YB, Choi SH, Jeong MH, Gwon HC, Hahn JY, Lee JM; FRAME-AMI Investigators. Clinical Value of Single-Projection Angiography-Derived FFR in Noninfarct-Related Artery. Circ Cardiovasc Interv. 2024 May;17(5):e013844. doi: 10.1161/CIRCINTERVENTIONS.123.013844. Epub 2024 May 21.

    PubMed 38771911

  • Hong D, Lee SH, Lee J, Lee H, Shin D, Kim HK, Park KH, Choo EH, Kim CJ, Kim MC, Hong YJ, Jeong MH, Ahn SG, Doh JH, Lee SY, Don Park S, Lee HJ, Kang MG, Koh JS, Cho YK, Nam CW, Choi KH, Park TK, Yang JH, Song YB, Choi SH, Gwon HC, Guallar E, Cho J, Hahn JY, Kang D, Lee JM; FRAME-AMI Investigators. Cost-Effectiveness of Fractional Flow Reserve-Guided Treatment for Acute Myocardial Infarction and Multivessel Disease: A Prespecified Analysis of the FRAME-AMI Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2352427. doi: 10.1001/jamanetworkopen.2023.52427.

    PubMed 38270954

  • Seung J, Choo EH, Kim CJ, Kim HK, Park KH, Lee SH, Kim MC, Hong YJ, Ahn SG, Doh JH, Lee SY, Park SD, Lee HJ, Kang MG, Koh JS, Cho YK, Nam CW, Koo BK, Lee BK, Yun KH, Hong D, Joh HS, Choi KH, Park TK, Lee JM, Yang JH, Song YB, Choi SH, Gwon HC, Hahn JY; FRAME-AMI Investigators. Angiographic Severity of the Nonculprit Lesion and the Efficacy of Fractional Flow Reserve-Guided Complete Revascularization in Patients With AMI: FRAME-AMI Substudy. Circ Cardiovasc Interv. 2024 Jan;17(1):e013611. doi: 10.1161/CIRCINTERVENTIONS.123.013611. Epub 2023 Nov 6.

    PubMed 37929584

  • Lee SH, Hong D, Shin D, Kim HK, Park KH, Choo EH, Kim CJ, Kim MC, Hong YJ, Ahn SG, Doh JH, Lee SY, Park SD, Lee HJ, Kang MG, Koh JS, Cho YK, Nam CW, Joh HS, Choi KH, Park TK, Yang JH, Song YB, Choi SH, Jeong MH, Gwon HC, Hahn JY, Lee JM; FRAME-AMI Investigators. QFR Assessment and Prognosis After Nonculprit PCI in Patients With Acute Myocardial Infarction. JACC Cardiovasc Interv. 2023 Oct 9;16(19):2365-2379. doi: 10.1016/j.jcin.2023.08.032.

    PubMed 37821181

  • Lee JM, Kim HK, Park KH, Choo EH, Kim CJ, Lee SH, Kim MC, Hong YJ, Ahn SG, Doh JH, Lee SY, Park SD, Lee HJ, Kang MG, Koh JS, Cho YK, Nam CW, Koo BK, Lee BK, Yun KH, Hong D, Joh HS, Choi KH, Park TK, Yang JH, Song YB, Choi SH, Gwon HC, Hahn JY; FRAME-AMI Investigators. Fractional flow reserve versus angiography-guided strategy in acute myocardial infarction with multivessel disease: a randomized trial. Eur Heart J. 2023 Feb 7;44(6):473-484. doi: 10.1093/eurheartj/ehac763.

    PubMed 36540034

  • Shin D, Rhee TM, Lee SH, Lee JM. Revascularization Strategies in Patients With ST-Segment Elevation Myocardial Infarction and Multivessel Disease: Is FFR-Guided Strategy Still Valuable? Korean Circ J. 2022 Apr;52(4):280-287. doi: 10.4070/kcj.2021.0416.

    PubMed 35388996

Questions about this trial

What is this clinical trial studying?

A study testing PCI using 2nd generation drug-eluting stent in people with Acute Myocardial Infarction, run by Samsung Medical Center at 1 site 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?

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: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient-oriented composite outcome (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02715518, which also lists 8 linked publications.

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 17 Apr 2024.

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