Comparing IVUS and FFR for treating artery lesions in heart attack patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to compare the clinical outcomes of two different treatment approaches for non-infarct related artery stenosis in patients experiencing acute myocardial infarction (AMI) with multivessel disease. It will evaluate the effectiveness of intravascular ultrasound (IVUS)-guided treatment versus fractional flow reserve (FFR)-guided treatment. The study will involve patients who have undergone successful primary percutaneous coronary intervention (PCI) within 12 hours of symptom onset. By analyzing the outcomes, the study seeks to determine which method provides better results for patients with significant non-infarct related artery lesions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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:
  1. Symptoms of ischemia.
  2. New or presumed new significant ST-T wave changes
  3. Development of pathological Q waves on electrocardiography.
  4. Imaging evidence of new or presumed new loss of viable myocardium or regional wall motion abnormality.
  5. 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.

Exclusion Criteria:

* 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.

Where it's running

• Samsung Medical Center
  Seoul, South Korea Recruiting
• Chonnam National University
  Gwangju, South Korea Not yet recruiting

Study contacts

• Principal investigator: Joo-Yong Hahn, MD, PhD — Samsung Medical Center
• Study coordinator: Joo Myung Lee, MD, MPH, PhD
• Email: drone80@hanmail.net
• Phone: 82-2-3410-2575

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.