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

NCT ID: NCT05698719

Last Updated: 2023-01-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 111 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-22
• Study Completion Date: 2023-06-22

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.

Detailed Description

The FAST STEMI II study is an investigator-initiated, multicenter, single-arm, observational cohort study aiming to include 111 patients presenting with ST-elevation myocardial infarction (STEMI). The study is designed to assess the diagnostic performance of acute-setting angiography-based fractional flow reserve (e.g. vessel fractional flow reserve (vFFR)) for the physiological assessment of intermediate non-culprit lesions, with acute-setting fractional flow reserve (FFR) and acute-setting non-hyperemic pressure ratio (NHPR) (e.g. resting full-cycle ratio (RFR)) as the reference standards.

Angiography-based FFR has the potential to guide complete revascularization in STEMI patients with multivessel disease, thereby reducing the need for invasive pressure wires and hyperemic agents. However, dedicated data regarding the diagnostic performance of acute-setting angiography-based FFR, with acute-setting FFR and NHPR as the reference standards, is currently lacking for this subset of patients.

Of note, FFR slightly underestimates the hemodynamic significance of non-culprit lesions in the acute setting due to microvascular constriction and a blunted hyperemic response, while NHPR slightly overestimates the functional lesion significance. Angiography-based fractional flow reserve is not affected by changes in the microvasculature. Potential discrepancies between acute-setting angiography-based FFR, FFR and NHPR might be explained by the microvascular state, expressed as coronary flow reserve (CFR) and the index of microvascular resistance (IMR).

Main objectives:

1. To study the diagnostic performance of acute-setting vFFR for the physiological assessment of intermediate non-culprit lesions in STEMI patients, with acute-setting FFR as the reference standard.

2. To study the diagnostic performance of acute-setting vFFR for the physiological assessment of intermediate non-culprit lesions in STEMI patients, with acute-setting RFR as the reference standards.

3. To study the impact of CFR and IMR on the potential discrepancies between acute-setting vFFR, FFR and RFR.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

STEMI patients undergoing physiological assessment of a non-culprit lesion

vFFR, FFR, RFR, dPR, CFR and IMR

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 18 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erasmus Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Joost Daemen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joost Daemen, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

Erasmus University Medical Center

Rotterdam, , Netherlands

Site Status: RECRUITING

Medical University of Warsaw

Warsaw, , Poland

Site Status: NOT_YET_RECRUITING

Countries

Netherlands; Poland

Central Contacts

Joost Daemen, MD PhD

Role: CONTACT

j.daemen@erasmusmc.nl

+31 (0)10 70 388 96

Frederik Groenland, MD

Role: CONTACT

f.groenland@erasmusmc.nl

+31 (0)10 70 388 96

Facility Contacts

Joost Daemen, MD PhD

Role: primary

j.daemen@erasmusmc.nl

+31(0)107035260

Mariusz Tomaniak, MD PhD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 40924133 (View on PubMed)

Other Identifiers

FAST STEMI II

Identifier Type: -

Identifier Source: org_study_id