Ireland
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Active, not recruiting Observational

Role of FFR in ACS Patients: Pressure ACS Registry

NCT05896501 · tracked via the Priya Life Science South Korea tracker
Phase
Observational
Started
2020-01-01
Last updated
2024-10-02

Condition(s) studied

Acute Coronary Syndrome

Investigational drug(s) / intervention(s)

Fractional Flow Reserve

Fractional Flow Reserve: Functional assessement of anatomical stenosis of coronary artery

Study summary

Currently, fractional flow reserve (FFR) is regarded as a gold-standard invasive method to define lesion-specific ischemia and FFR-guided PCI has been proven to reduce unnecessary revascularization and to enhance patient's clinical outcomes. Therefore, current guidelines recommend FFR measurement for intermediate coronary stenosis when there is no definite evidence of lesion-specific ischemia. However, previous evidences which well demonstrated the benefit of FFR-guided strategy were mostly generated from patients with stable coronary artery disease.4 FFR may be overestimated and the hemodynamic relevance of a coronary stenosis underestimated in patients with acute coronary syndrome (ACS).Its role in ACS patients still needs to be defined although several studies have recently published addressing the value of FFR-guided PCI in ACS. In fact, recent evidence suggests that culprit lesions of patients presenting with a non-ST-segment elevation myocardial infarction that were deferred based on a "negative" FFR have a relatively high event rate, calling into question the use of FFR in that patient population.

Eligibility

Sex
ALL
Min age
19 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: * Subject age 19-85 years old * Diagnosed as ACS (unstable angina/ Non ST elevation myocardial infarction, ST elevation myocardial infarction) * At least one stenosis of \>50% in a non-culprit vessel ≥ 2.0 mm by visual estimation with TIMI 3 - multivessel disease after PCI for culprit lesion or single vessel disease with ambiguity for PCI ④ FFR within hospitalization for index PCI for ACS Exclusion Criteria: * Severe stenosis with TIMI flow ≤ II of the non-IRA artery * Cardiogenic shock (Killip class IV) already at presentation or the completion of culprit PCI * Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparin, Bivaluridin, or Everolimus * Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock) ⑤ Pregnancy or breast feeding ⑥ Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol noncompliance (per site investigator's medical judgment). ⑦ Other primary valvular disease with severe degree: severe mitral regurgitation or mitral stenosis, severe aortic regurgitation or aortic stenosis ⑧ Patients with a history of Coronary Artery Bypass Graft(CABG) ⑨ Unwillingness or inability to comply with the procedures described in this protocol.

Primary outcome measure(s)

  • Rate of Major adverse cardiac events — 24 months
    Rate of the composite of all-cause death, recurrent myocardial infarction

Trial sites (5)

FacilityCityRegionStatus
St.Vincent's Hospital Suwon Gyeonggido
Uijeongbu St.Mary's Hospital Uijeongbu-si Gyeonggido
Daejeon St.Mary's Hospital Daejeon South Korea
Incheon St.Mary's Hospital Incheon South Korea
The Catholic University of Korea Seoul St. Mary's Hospital Seoul South Korea
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05896501 on ClinicalTrials.gov ↗ ← All trials in South Korea