Back to results

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

Primary Purpose

Acute Myocardial Infarction

Status

Active

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

PCI using 2nd generation drug-eluting stent

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Acute ST-segment elevation myocardial infarction, Acute myocardial infarction, Fractional flow reserve, Percutaneous coronary intervention, Multivessel disease, STEMI, NSTEMI

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

(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 "
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.

Sites / Locations

Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

FFR-guided strategy arm

Angiography-guided strategy arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Patient-oriented composite outcome

a composite of death, myocardial infarction, or repeat revascularization

Secondary Outcome Measures

All-cause mortality

Cardiac death

Any myocardial infarction without procedure-related myocardial infarction

Any myocardial infarction with periprocedural myocardial infarction

Any revascularization

ischemia-driven or all

Infarct-related artery (IRA) repeat revascularization

ischemia-driven or all

Non-IRA repeat revascularization

ischemia-driven or all

Stent thrombosis

ARC-defined definite stent thrombosis

Stroke

ischemic and hemorrhagic

Total amount of contrast use

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

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

Seattle Angina Questionnaires

Angina severity

Seattle Angina Questionnaires

Angina severity

All-cause death and myocardial infarction

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

Death, spontaneous myocardial infarction, or repeat revascularization

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

Full Information

NCT ID

NCT02715518

First Posted

March 16, 2016

Last Updated

September 6, 2022

Sponsor

Samsung Medical Center

Collaborators

Seoul National University Hospital, Inje University, Keimyung University Dongsan Medical Center, Sejong General Hospital, Wonju Severance Christian Hospital, Chungbuk National University Hospital, Chosun University Hospital, Inha University Hospital, Gyeongsang National University Hospital, KangWon National University Hospital, Incheon St.Mary's Hospital, Uijeongbu St. Mary Hospital, Ajou University School of Medicine, Chonnam National University Hospital, Kosin University Gospel Hospital, Samsung Changwon Hospital, Kangbuk Samsung Hospital, Yeungnam University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02715518

Brief Title

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

Acronym

FRAME-AMI

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

August 19, 2016 (Actual)

Primary Completion Date

June 30, 2022 (Actual)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Samsung Medical Center

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myocardial Infarction

Keywords

Acute ST-segment elevation myocardial infarction, Acute myocardial infarction, Fractional flow reserve, Percutaneous coronary intervention, Multivessel disease, STEMI, NSTEMI

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Masking Description

Clinical event adjudication and statistical analysis will be blindly performed by independent investigators.

Allocation

Randomized

Enrollment

1292 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

FFR-guided strategy arm

Arm Type

Active Comparator

Arm Description

Arm Title

Angiography-guided strategy arm

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

PCI using 2nd generation drug-eluting stent

Intervention Description

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

Primary Outcome Measure Information:

Title

Patient-oriented composite outcome

Description

a composite of death, myocardial infarction, or repeat revascularization

Time Frame

24 months

Secondary Outcome Measure Information:

Title

All-cause mortality

Description

All-cause mortality

Time Frame

24 months

Title

Cardiac death

Description

Cardiac death

Time Frame

24 months

Title

Any myocardial infarction without procedure-related myocardial infarction

Description

Any myocardial infarction without procedure-related myocardial infarction

Time Frame

24 months

Title

Any myocardial infarction with periprocedural myocardial infarction

Description

Any myocardial infarction with periprocedural myocardial infarction

Time Frame

24 months

Title

Any revascularization

Description

ischemia-driven or all

Time Frame

24 months

Title

Infarct-related artery (IRA) repeat revascularization

Description

ischemia-driven or all

Time Frame

24 months

Title

Non-IRA repeat revascularization

Description

ischemia-driven or all

Time Frame

24 months

Title

Stent thrombosis

Description

ARC-defined definite stent thrombosis

Time Frame

24 months

Title

Stroke

Description

ischemic and hemorrhagic

Time Frame

24 months

Title

Total amount of contrast use

Description

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

Time Frame

1 week

Title

Incidence of contrast-induced nephropathy

Description

defined as an increase in serum creatinine of ≥0.5mg/dL or ≥25% from baseline within 48-72 hours after contrast agent exposure

Time Frame

3 days

Title

Seattle Angina Questionnaires

Description

Angina severity

Time Frame

12-month

Title

Seattle Angina Questionnaires

Description

Angina severity

Time Frame

24-month

Title

All-cause death and myocardial infarction

Description

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

Time Frame

24-month

Title

Death, spontaneous myocardial infarction, or repeat revascularization

Description

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

Time Frame

24-month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

(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 " 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joo-Yong Hahn, MD, PhD

Organizational Affiliation

Samsung Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Samsung Medical Center

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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

IPD Sharing Time Frame

After reporting of the main results.

IPD Sharing Access Criteria

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

Citations:

PubMed Identifier

35388996

Citation

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs