Randomized Controlled Trial of Intravascular Ultrasound Versus Fractional Flow Reserve for Non-infarct Related Artery Lesions in Patients With Multivessel Disease and Acute Myocardial Infarction

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Republic of Korea
Chonnam National University
NOT_YET_RECRUITING
Gwangju
Samsung Medical Center
RECRUITING
Seoul
Contact Information
Primary
Joo Myung Lee, MD, MPH, PhD
drone80@hanmail.net
82-2-3410-2575
Backup
Joo-Yong Hahn, MD, PhD
jooyong.hahn@gmail.com
82-2-3410-3419
Time Frame
Start Date: 2023-09-18
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 1400
Treatments
Active_comparator: Fractional flow reserve-guided PCI
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.
Experimental: Intravascular Ultrasound-guided PCI
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%.
Related Therapeutic Areas
Sponsors
Collaborators: Chonnam National University
Leads: Samsung Medical Center

This content was sourced from clinicaltrials.gov