Actively Recruiting

Phase Not Applicable
Age: 19Years +
All Genders
NCT05812963

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

Led by Samsung Medical Center · Updated on 2024-10-24

1400

Participants Needed

2

Research Sites

328 weeks

Total Duration

On this page

Sponsors

S

Samsung Medical Center

Lead Sponsor

C

Chonnam National University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subject must be at least 19 years of age
  • Acute ST-segment elevation myocardial infarction (STEMI), defined as ST-segment elevation ≥0.1 mV in ≥2 contiguous leads or new left bundle-branch block
  • Acute non-ST-segment elevation myocardial infarction (NSTEMI), defined by elevated cardiac biomarkers plus symptoms or ECG/imaging evidence
  • Successful primary percutaneous coronary intervention (PCI) within 12 hours of symptom onset for STEMI or within 72 hours for NSTEMI
  • Multivessel disease with at least one stenosis >50% in a non-infarct related artery ≥2.25 mm by visual estimation
  • Ability to understand risks, benefits, and alternatives and provide written informed consent
Not Eligible

You will not qualify if you...

  • Non-infarct related artery stenosis not suitable for PCI based on operator decision
  • Cardiogenic shock (Killip class IV) at presentation or after infarct-related artery PCI
  • Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparin, or Everolimus
  • Known true anaphylaxis to contrast media
  • Pregnancy or breastfeeding
  • Non-cardiac conditions with life expectancy less than 2 years or likely protocol non-compliance
  • Severe primary valvular heart disease including severe mitral or aortic regurgitation or stenosis
  • Unwillingness or inability to follow study procedures

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Chonnam National University

Gwangju, South Korea

Not Yet Recruiting

2

Samsung Medical Center

Seoul, South Korea

Actively Recruiting

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Research Team

J

Joo Myung Lee, MD, MPH, PhD

CONTACT

J

Joo-Yong Hahn, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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