Actively Recruiting
Optimal Timing of Fractional Flow Reserve-Guided Complete Revascularization in Non-ST-Segment Elevation Myocardial Infarction (OPTION-NSTEMI)
Led by Chonnam National University Hospital · Updated on 2026-04-27
1014
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the best timing and strategy for revascularization in patients who have non-ST-segment elevation myocardial infarction (NSTEMI) with multivessel coronary artery disease (MVD), a condition linked to worse clinical outcomes. This trial compares immediate complete revascularization, where both the infarct-related artery (IRA) and other affected arteries are treated during the initial procedure, to a staged approach where the non-IRA is treated days later. The study aims to assess the safety and effectiveness of these two approaches, particularly using fractional flow reserve (FFR) to guide treatment for arteries with moderate narrowing.
CONDITIONS
Brief Title
Timing of FFR-guided PCI for Non-IRA in NSTEMI and MVD (OPTION-NSTEMI)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 19 years or older
- Diagnosis of non-ST-segment elevation myocardial infarction (NSTEMI) with chest pain or equivalent ischemic symptoms
- Elevated cardiac biomarkers indicating heart muscle injury
- No ST-segment elevation on ECG or new left bundle branch block
- Undergoing percutaneous coronary intervention (PCI) within 72 hours of symptoms
- Multivessel coronary artery disease with at least one non-infarct artery showing 50% or more narrowing and diameter of 2.5 mm or greater
- Agreement from patient or protector to participate and accept PCI risks
You will not qualify if you...
- Cardiogenic shock at presentation or after treatment of the infarct artery
- Poor blood flow (TIMI flow 2 or less) in non-infarct arteries
- Severe complications during PCI that prevent enrollment
- Non-infarct artery lesions unsuitable for PCI
- Chronic total occlusion in non-infarct arteries
- History of allergic reaction to contrast agents
- Pregnancy or breastfeeding
- Life expectancy less than 1 year
- Severe heart valve disease
- History of or planned coronary artery bypass graft surgery (CABG)
- Received fibrinolytic therapy before admission
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to several days during hospitalization
Participants undergo percutaneous coronary intervention (PCI) for the infarct-related artery (IRA). They are then randomized to receive either immediate complete revascularization, where PCI for both IRA and non-infarct-related arteries (non-IRA) occurs during the same procedure, or staged complete revascularization, where PCI for non-IRA is performed during a separate hospital visit after the initial PCI. Non-IRA lesions with 50-69% diameter stenosis are evaluated using fractional flow reserve (FFR) to decide on PCI, while lesions with 70% or greater stenosis are treated without FFR evaluation.
1 to 2 visits (in-person) depending on treatment assignment
Duration - Up to 12 months
Participants are monitored for up to 12 months after treatment to assess clinical outcomes such as survival, revascularization events, and complications.
Periodic visits during 12-month follow-up
Trial Site Locations
Total: 1 location
1
Chonnam National University Hospital
Gwangju, South Korea
Actively Recruiting
Research Team
M
Min Chul Kim, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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