NCT05812963Recruiting
IVUS Versus FFR for Non-infarct Related Artery Lesions in Patients With Multivessel Disease and Acute MI
Randomized Controlled Trial of Intravascular Ultrasound Versus Fractional Flow Reserve for Non-infarct Related Artery Lesions in Patients With Multivessel Disease and Acute Myocardial Infarction
Source: ClinicalTrials.gov · Last updated 24 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1400 (estimated)
- First submitted
- 22 Feb 2023
- Start date
- 18 Sept 2023
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Samsung Medical Center
- Diseases
- Coronary artery disease
- NCT number
- NCT05812963
What you commit to
- Study type: Interventional
- Planned participants: 1400
- From 18 Sept 2023 to the primary completion date, 31 Dec 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock)
- 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
Other
- 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
- Pregnancy or breast feeding
- Unwillingness or inability to comply with the procedures described in this protocol.
Who the study is looking for
- 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:
- 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 written informed consent prior to any study related procedure.
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chonnam National University Coordinator of this site? Confirm its status | Gwangju | South Korea | Not yet recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.