NCT02715518Completed
FFR Versus Angiography-Guided Strategy for Management of AMI With Multivessel Disease
Comparison of Clinical Outcomes Between Fractional Flow Reserve-guided Strategy and Angiography-guided Strategy in Treatment of Non-Infarction Related Artery Stenosis in Patients With Acute Myocardial Infarction
Source: ClinicalTrials.gov · Last updated 17 Apr 2024
Brief summary (registry, in English)
The aim of the study is to compare clinical outcomes following fractional flow reserve (FFR)-guided versus angiography only guided strategy in treatment of non-infarction related artery (non-IRA) stenosis in patients with acute myocardial infarction (AMI) with multivessel disease Prospective, open-label, randomized, multicenter trial to test the clinical outcomes following FFR-guided or angiography-guided strategy in treatment of non-IRA stenosis in patients with acute AMI with multivessel disease.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 1292 (actual)
- First submitted
- 16 Mar 2016
- Start date
- 19 Aug 2016
- Primary completion date
- 30 Jun 2022
- Lead sponsor
- Samsung Medical Center
- Diseases
- Coronary artery disease
- NCT number
- NCT02715518
What you commit to
- Study type: Interventional
- Participants enrolled: 1292
- From 19 Aug 2016 to the primary completion date, 30 Jun 2022
- 1 site 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.
Criteria the registry did not label
- (1) Inclusion Criteria
- Subject must be at least 19 years of age
- Acute ST-segment elevation myocardial infarction (STEMI) A. ※ STEMI: "ST-segment elevation ≥0.1 mV in ≥2 contiguous leads B. 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 ischaemia.
- New or presumed new significant ST-T wave changes
- Development of pathological Q waves on electrocardiography (ECG).
- Imaging evidence of new or presumed new loss of viable myocardium or regional wall motion abnormality.
- Intracoronary thrombus detected on angiography.
- 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-culprit vessel ≥ 2.0 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.
- (2) Exclusion criteria
- Severe stenosis with TIMI flow ≤ II of the non-IRA artery
- Unprotected left main coronary artery disease (stenosis \> 50% by visual estimation)
- Non-IRA stenosis not amenable for PCI treatment by operators' decision)
- Chronic total occlusion in non-IRA
- Cardiogenic shock (Killip class IV) already at presentation or the completion of IRA PCI
- Intolerance to Aspirin, Clopidogrel, Plasugrel, Ticagrelor, Heparin, Bivaluridin, or Everolimus, Zotarolimus
- 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 \<1 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
- Patients with a history of Coronary Artery Bypass Graft (CABG) or treated with fibrinolytic Therapy
- Unwillingness or inability to comply with the procedures described in this protocol.
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.