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Compares treatment options for ST Elevation Myocardial Infarction
Official title IVUS Versus FFR for Non-infarct Related Artery Lesions in Patients With Multivessel Disease and Acute MI
ClinicalTrials.gov ID: NCT05812963
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- 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...
- Acute non-ST-segment elevation myocardial infarction (NSTEMI) \ NSTEMI: NSTEMI is defined as a combination of criteria with mandated elevation of a...
- Symptoms of ischemia.
- New or presumed new significant ST-T wave changes
You likely can't join if
- 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...
See the full eligibility 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Gwangju, South Korea
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gwangju, South Korea; Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.