FFR Versus Angiography-Guided Strategy for Management of AMI With Multivessel Disease (FRAME-AMI)
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ClinicalTrials.gov Identifier: NCT02715518 |
Recruitment Status :
Active, not recruiting
First Posted : March 22, 2016
Last Update Posted : September 8, 2022
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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.
Condition or disease | Intervention/treatment | Phase |
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Acute Myocardial Infarction | Device: PCI using 2nd generation drug-eluting stent | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1292 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Investigator, Outcomes Assessor) |
Masking Description: | Clinical event adjudication and statistical analysis will be blindly performed by independent investigators. |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | August 19, 2016 |
Actual Primary Completion Date : | June 30, 2022 |
Estimated Study Completion Date : | December 31, 2022 |

Arm | Intervention/treatment |
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Active Comparator: FFR-guided strategy arm
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
Percutaneous coronary intervention (PCI) using 2nd generation drug-eluting stent for non-IRA stenosis will be decided according to the allocated arms.
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Active Comparator: Angiography-guided strategy arm
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
Percutaneous coronary intervention (PCI) using 2nd generation drug-eluting stent for non-IRA stenosis will be decided according to the allocated arms.
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- Patient-oriented composite outcome [ Time Frame: 24 months ]a composite of death, myocardial infarction, or repeat revascularization
- All-cause mortality [ Time Frame: 24 months ]All-cause mortality
- Cardiac death [ Time Frame: 24 months ]Cardiac death
- Any myocardial infarction without procedure-related myocardial infarction [ Time Frame: 24 months ]Any myocardial infarction without procedure-related myocardial infarction
- Any myocardial infarction with periprocedural myocardial infarction [ Time Frame: 24 months ]Any myocardial infarction with periprocedural myocardial infarction
- Any revascularization [ Time Frame: 24 months ]ischemia-driven or all
- Infarct-related artery (IRA) repeat revascularization [ Time Frame: 24 months ]ischemia-driven or all
- Non-IRA repeat revascularization [ Time Frame: 24 months ]ischemia-driven or all
- Stent thrombosis [ Time Frame: 24 months ]ARC-defined definite stent thrombosis
- Stroke [ Time Frame: 24 months ]ischemic and hemorrhagic
- Total amount of contrast use [ Time Frame: 1 week ]From primary PCI to end of the procedure including amount of staged procedure
- Incidence of contrast-induced nephropathy [ Time Frame: 3 days ]defined as an increase in serum creatinine of ≥0.5mg/dL or ≥25% from baseline within 48-72 hours after contrast agent exposure
- Seattle Angina Questionnaires [ Time Frame: 12-month ]Angina severity
- Seattle Angina Questionnaires [ Time Frame: 24-month ]Angina severity
- All-cause death and myocardial infarction [ Time Frame: 24-month ]A composite of all-cause death and any myocardial infarction (MI) according to the ARC consensus
- Death, spontaneous myocardial infarction, or repeat revascularization [ Time Frame: 24-month ]A composite of Death, spontaneous myocardial infarction, or repeat revascularization

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Ages Eligible for Study: | 19 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
(1) Inclusion Criteria
- 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 "
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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.
(2) Exclusion criteria
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02715518
Korea, Republic of | |
Samsung Medical Center | |
Seoul, Korea, Republic of |
Principal Investigator: | Joo-Yong Hahn, MD, PhD | Samsung Medical Center |
Responsible Party: | Joo-Yong Hahn, Professor, Samsung Medical Center |
ClinicalTrials.gov Identifier: | NCT02715518 |
Other Study ID Numbers: |
FRAME16453143 |
First Posted: | March 22, 2016 Key Record Dates |
Last Update Posted: | September 8, 2022 |
Last Verified: | September 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (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 |
Acute ST-segment elevation myocardial infarction Acute myocardial infarction Fractional flow reserve Percutaneous coronary intervention |
Multivessel disease STEMI NSTEMI |
Myocardial Infarction Infarction Ischemia Pathologic Processes Necrosis |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |