NCT02715518

Brief 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, 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,292

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 22, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

August 19, 2016

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

5.9 years

First QC Date

March 16, 2016

Last Update Submit

April 15, 2024

Conditions

Acute Myocardial Infarction

Keywords

Acute ST-segment elevation myocardial infarctionAcute myocardial infarctionFractional flow reservePercutaneous coronary interventionMultivessel diseaseSTEMINSTEMI

Outcome Measures

Primary Outcomes (1)

  • Patient-oriented composite outcome

    a composite of death, myocardial infarction, or repeat revascularization

    24 months

Secondary Outcomes (15)

  • All-cause mortality

    24 months

  • Cardiac death

    24 months

  • Any myocardial infarction without procedure-related myocardial infarction

    24 months

  • Any myocardial infarction with periprocedural myocardial infarction

    24 months

  • Any revascularization

    24 months

  • +10 more secondary outcomes

Study Arms (2)

FFR-guided strategy arm

ACTIVE COMPARATOR

FFR 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.

Device: PCI using 2nd generation drug-eluting stent

Angiography-guided strategy arm

ACTIVE COMPARATOR

Non-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.

Device: PCI using 2nd generation drug-eluting stent

Interventions

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

Angiography-guided strategy armFFR-guided strategy arm

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject must be at least 19 years of age
  • 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 "
  • Acute non-ST-segment elevation myocardial infarction (NSTEMI)
  • A. ※ 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:
  • Symptoms of ischaemia.
  • New or presumed new significant ST-T wave changes
  • Development of pathological Q waves on electrocardiography (ECG).
  • Imaging evidence of new or presumed new loss of viable myocardium or regional wall motion abnormality.
  • Intracoronary thrombus detected on angiography.
  • 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)
  • Multivessel disease (at least one stenosis of \>50% in a non-culprit vessel ≥ 2.0 mm by visual estimation)
  • 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:

  • Severe stenosis with TIMI flow ≤ II of the non-IRA artery
  • Unprotected left main coronary artery disease (stenosis \> 50% by visual estimation)
  • Non-IRA stenosis not amenable for PCI treatment by operators' decision)
  • Chronic total occlusion in non-IRA
  • Cardiogenic shock (Killip class IV) already at presentation or the completion of IRA PCI
  • Intolerance to Aspirin, Clopidogrel, Plasugrel, Ticagrelor, Heparin, Bivaluridin, or Everolimus, Zotarolimus
  • 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 \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
  • Other primary valvular disease with severe degree: severe mitral regurgitation, mitral stenosis, severe aortic regurgitation, or aortic stenosis
  • Patients with a history of Coronary Artery Bypass Graft (CABG) or treated with fibrinolytic Therapy
  • Unwillingness or inability to comply with the procedures described in this protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (8)

  • 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.

    PMID: 40878980DERIVED

  • 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.

    PMID: 39726942DERIVED

  • 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.

    PMID: 38771911DERIVED

  • 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.

    PMID: 38270954DERIVED

  • 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.

    PMID: 37929584DERIVED

  • 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.

    PMID: 37821181DERIVED

  • 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.

    PMID: 36540034DERIVED

  • 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.

    PMID: 35388996DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionNon-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Joo-Yong Hahn, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Clinical event adjudication and statistical analysis will be blindly performed by independent investigators.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 16, 2016

First Posted

March 22, 2016

Study Start

August 19, 2016

Primary Completion

June 30, 2022

Study Completion

December 31, 2023

Last Updated

April 17, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
After reporting of the main results.
Access Criteria
After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked

Locations

KR(1)