Role of FFR in ACS Patients: Pressure ACS Registry

NCT05896501 | Active Not Recruiting DMC

• 1 other identifier: PressureACS
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• Rate of Major adverse cardiac events

  Rate of the composite of all-cause death, recurrent myocardial infarction

  24 months

Secondary Outcomes (4)

• Rate of Major adverse cardiac events at 1 year

  12 months

• Rate of Ischemic events

  24 months

• Rate of Death

  24 months

• Rate of Repeat revascularization

  24 months

Interventions

Fractional Flow Reserve DEVICE

Functional assessement of anatomical stenosis of coronary artery

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with acute coronary syndrome and intermediate stenosis

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Catholic University of Korea: lead

Study Sites (5)

St.Vincent's Hospital

Suwon, Gyeonggido, South Korea

Location

Uijeongbu St.Mary's Hospital

Uijeongbu-si, Gyeonggido, South Korea

Location

Daejeon St.Mary's Hospital

Daejeon, South Korea

Location

Incheon St.Mary's Hospital

Incheon, South Korea

Location

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Eun Ho Choo, M.D.,PhD

  The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: June 9, 2023
• Study Start: January 1, 2020
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 2, 2024

Record last verified: 2024-10

Locations

KR (5)