Validation of vFFR as Compared to FFR to Guide Revascularization of Non-culprit Lesions in STEMI Patients

NCT05698719 | Unknown

• 1 other identifier: FAST STEMI II
• Study Type: observational
• Target: 111
• Locations: 2 countries
• Sites: 2

Brief Summary

This prospective multicenter observational cohort study is designed to study the diagnostic performance of acute-setting angiography-based FFR (e.g. vFFR) for the physiological assessment of intermediate non-culprit lesions in STEMI patients, with acute-setting FFR and acute-setting NHPR (e.g. RFR) as the reference standards.

Conditions

ST Elevation Myocardial Infarction; Multivessel Coronary Artery Disease; Percutaneous Coronary Intervention

Keywords

Pressure wire-based coronary physiology (FFR, RFR, dPR); Angiography-based coronary physiology (vFFR)

Outcome Measures

Primary Outcomes (1)

• The diagnostic performance of acute-setting vFFR for the physiological assessment of intermediate non-culprit lesions, with acute-setting FFR as the reference standard.

  Diagnostic performance: sensitivity, specificity, diagnostic accuracy, positive predictive value and negative predictive value (ischemic cutoff value acute-setting vFFR and acute-setting FFR: ≤0.80).

  Intraprocedural (0 days)

Secondary Outcomes (7)

• The diagnostic performance of acute-setting vFFR for the physiological assessment of intermediate non-culprit lesions, with acute-setting RFR as the reference standard.

  Intraprocedural (0 days)

• The diagnostic performance of acute-setting RFR for the physiological assessment of intermediate non-culprit lesions, with acute-setting FFR as the reference standard.

  Intraprocedural (0 days)

• The diagnostic performance of acute-setting vFFR for the physiological assessment of intermediate non-culprit lesions, with offline dPR as the reference standard.

  Postprocedural (max. 7 days)

• The diagnostic performance of offline vFFR for the physiological assessment of intermediate non-culprit lesions, with acute-setting FFR and RFR as the reference standards.

  Postprocedural (max. 7 days)

• The diagnostic performance of offline vFFR for the physiological assessment of intermediate non-culprit lesions, with offline dPR as the reference standard.

  Postprocedural (max. 7 days)

Study Arms (1)

STEMI patients undergoing physiological assessment of a non-culprit lesion

vFFR, FFR, RFR, dPR, CFR and IMR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

STEMI patients with multivessel disease undergoing primary percutaneous coronary intervention.

You may qualify if:

• years or older.
• At least one intermediate non-culprit lesion (50-90% diameter stenosis by visual estimation or online QCA) in a non-infarct related artery (reference vessel diameter \>2.00 mm) for which invasive pressure wire-based physiological assessment is deemed feasible and indicated.

You may not qualify if:

• Presentation with cardiac arrest or cardiogenic shock.
• Previous coronary artery bypass graft surgery or percutaneous coronary intervention involving the non-culprit vessel.
• Ostial left main or ostial right coronary artery lesion.
• Excessive overlap, foreshortening or tortuosity precluding vFFR computation.

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (2)

Erasmus University Medical Center

Rotterdam, 3015GD, Netherlands

RECRUITING

Medical University of Warsaw

Warsaw, Poland

NOT YET RECRUITING

Related Publications (1)

• van der Eijk JA, Groenland FTW, Scoccia A, Ziedses des Plantes AC, Huang J, Nuis RJ, Wilschut JM, den Dekker WK, Diletti R, Kardys I, Tomaniak M, Van Mieghem NM, Daemen J. Validation of angiography-based FFR in non-culprit vessels of patients presenting with STEMI. Clin Res Cardiol. 2025 Sep 8. doi: 10.1007/s00392-025-02729-x. Online ahead of print.

  PMID: 40924133 DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Dermatopathia pigmentosa reticularis

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Joost Daemen, MD PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joost Daemen, MD PhD

CONTACT

+31 (0)10 70 388 96; j.daemen@erasmusmc.nl

Frederik Groenland, MD

CONTACT

+31 (0)10 70 388 96; f.groenland@erasmusmc.nl

Study Design

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

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: January 26, 2023
• Study Start: June 22, 2022
• Primary Completion: June 22, 2023
• Study Completion: June 22, 2023
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); PL (1)