IVUS Versus FFR for Non-infarct Related Artery Lesions in Patients With Multivessel Disease and Acute MI

NCT05812963 | Recruiting DMC

• 1 other identifier: FRAMEAMI119023
• Study Type: interventional
• Target: 1,400
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of the study is to compare clinical outcomes between intravascular ultrasound (IVUS)-guided treatment decision versus fractional flow reserve (FFR)-guided treatment decision for non-infarct related artery stenosis in patients with acute myocardial infarction (AMI) and multivessel disease.

Conditions

ST Elevation Myocardial Infarction; Non-ST Elevation Myocardial Infarction

Keywords

ST-segment elevation MI; Fractional flow reserve; intravascular ultrasound; Multivessel disease; Complete revascularization; Non-ST Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Patient-Oriented Composite Outcome

  a composite of death, myocardial infarction, or repeat revascularization

  2 years after last patient enrollment

Secondary Outcomes (17)

• All-cause death

  2 years after last patient enrollment

• Cardiac death

  2 years after last patient enrollment

• Spontaneous myocardial infarction

  2 years after last patient enrollment

• Procedure-related myocardial infarction

  2 years after last patient enrollment

• Any revascularization

  2 years after last patient enrollment

Study Arms (2)

Fractional flow reserve-guided PCI

ACTIVE COMPARATOR

FFR measurement for non-IRA stenosis (\>50% visual estimation) will be performed by continuous infusion of adenosine (140\~180 ug/kg/min) or intracoronary nicorandil (2 mg bolus) injection. The FFR ≤0.80 will be targeted for PCI. In case of non-IRA stenosis \>90%, we will judge FFR value of ≤0.80.

Diagnostic Test: FFR-guided PCI group

Intravascular Ultrasound-guided PCI

EXPERIMENTAL

In IVUS-guided PCI group, the current trial evaluates clinical outcome following IVUS-guided treatment decision for revascularization of non-IRA stenosis. According to pre-defined criteria, the decision of revascularization will be made. Revascularization criteria in the IVUS-guided PCI group is 1) minimal lumen area (MLA) ≤ 3mm2 or 2) 3mm2 \< MLA ≤4mm2 and plaque burden \>70%.

Diagnostic Test: IVUS-guided PCI group

Interventions

IVUS-guided PCI group DIAGNOSTIC_TEST

In IVUS-guided PCI group, the current trial evaluates clinical outcome following IVUS-guided treatment decision for revascularization of non-IRA stenosis.

Intravascular Ultrasound-guided PCI

FFR-guided PCI group DIAGNOSTIC_TEST

In FFR-guided PCI group, FFR measurement for non-IRA stenosis (\>50% visual estimation) will be performed by continuous infusion of adenosine (140\~180 ug/kg/min) or intracoronary nicorandil (2 mg bolus) injection. The FFR ≤0.80 will be targeted for PCI. In case of non-IRA stenosis \>90%, we will judge FFR value of ≤0.80.

Fractional flow reserve-guided PCI

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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)
• \*STEMI: ST-segment elevation ≥0.1 mV in ≥2 contiguous leads or documented newly developed left bundle-branch block
• Acute non-ST-segment elevation myocardial infarction (NSTEMI)
• \*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 ischemia.
• New or presumed new significant ST-T wave changes
• Development of pathological Q waves on electrocardiography.
• Imaging evidence of new or presumed new loss of viable myocardium or regional wall motion abnormality.
• Intracoronary thrombus detected on angiography.
• Successful 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-IRA ≥2.25 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:

• Non-IRA stenosis not amenable for PCI treatment by operators' decision
• Cardiogenic shock (Killip class IV) already at presentation or the completion of IRA PCI
• Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparin, or Everolimus
• 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 \<2 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
• Unwillingness or inability to comply with the procedures described in this protocol.

Sponsors & Collaborators

• Samsung Medical Center: lead
• Chonnam National University: collaborator

Study Sites (2)

Chonnam National University

Gwangju, South Korea

NOT YET RECRUITING

Samsung Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Joo-Yong Hahn, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

• Young Joon Hong, MD, PhD

  Chonnam National University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joo Myung Lee, MD, MPH, PhD

CONTACT

82-2-3410-2575; drone80@hanmail.net

Joo-Yong Hahn, MD, PhD

CONTACT

82-2-3410-3419; jooyong.hahn@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Clinical events will be independently adjudicated by Clinical Event Adjudication Committee (CEAC) who are blinded to clinical information or group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Prospective, multicenter, randomized controlled non-inferiority trial to compare clinical outcomes between IVUS-guided PCI versus FFR-guided PCI in patients with acute MI and multivessel disease.

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: April 14, 2023
• Study Start: September 18, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After publication of main paper.
• Access Criteria: Executive Committee will discuss to share the de-identified data upon reasonable requests.

Locations

KR (2)