Actively Recruiting

Phase Not Applicable
Age: 19Years +
All Genders
NCT04968808

Timing of FFR-guided PCI for Non-IRA in NSTEMI and MVD (OPTION-NSTEMI)

Led by Chonnam National University Hospital · Updated on 2026-04-27

1014

Participants Needed

1

Research Sites

365 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Many patients with non-ST-segment elevation myocardial infarction (NSTEMI) have multivessel coronary artery disease (MVD), which is associated with poor clinical outcomes. However, there have been few studies regarding revascularization strategy in patients with NSTEMI and MVD. Therefore, we planned to perform prospective, open-label, randomized trial to evaluate the efficacy and safety of immediate complete revascularization (percutaneous coronary intervention \[PCI\] for both infarct-related artery \[IRA\] and non-IRA during index PCI) compared to staged PCI strategy of non-IRA (PCI for IRA followed by non-IRA PCI after several days). PCI procedure at non-IRA with diameter stenosis between 50 and 69% should be conducted with the aid of fractional flow reserve (FFR), and non-IRA with diameter stenosis ≥ 70% will be revascularized without FFR.

CONDITIONS

Official Title

Timing of FFR-guided PCI for Non-IRA in NSTEMI and MVD (OPTION-NSTEMI)

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 19 years or older
  • Diagnosed with non-ST-segment elevation myocardial infarction (NSTEMI) confirmed by chest pain or equivalent ischemic symptoms with at least one of the following: occurs at rest lasting more than 10 minutes, new severe onset within 4-6 weeks, or worsening pattern
  • Elevated cardiac biomarkers with high-sensitivity troponin values at or above 99% threshold
  • No significant ST-segment elevation on ECG or new left bundle branch block
  • Undergoing percutaneous coronary intervention (PCI) within 72 hours of symptom onset
  • Multivessel disease involving non-infarct arteries with at least 2.5 mm diameter and 50% or greater stenosis
  • Agreement by patient or protector to participate and understand study risks
Not Eligible

You will not qualify if you...

  • Cardiogenic shock at initial presentation or after infarct-related artery treatment
  • TIMI flow grade 2 or less in non-infarct-related arteries
  • Severe complications during procedure such as no-reflow or coronary perforation preventing study participation
  • Non-infarct artery lesions deemed unsuitable for PCI
  • Presence of 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
  • Previous or planned coronary artery bypass graft surgery
  • Received fibrinolysis treatment before hospital admission

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Chonnam National University Hospital

Gwangju, South Korea

Actively Recruiting

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Research Team

M

Min Chul Kim, MD

CONTACT

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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