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

January 16, 2023 updated by: Joost Daemen, Erasmus Medical Center

Validation of Angiography-based FFR as Compared to Pressure Wire-based FFR to Guide Revascularization of Intermediate Coronary Lesions in Non-culprit Vessels in Patients Presenting With ST-segment Elevation Myocardial Infarction

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

111

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
      • Rotterdam, Netherlands, 3015GD
        • Recruiting
        • Erasmus University Medical Center
        • Contact:
  • Poland
      • Warsaw, Poland
        • Not yet recruiting
        • Medical University of Warsaw
        • Contact:
          • Mariusz Tomaniak, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

STEMI patients with multivessel disease undergoing primary percutaneous coronary intervention.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
STEMI patients undergoing physiological assessment of a non-culprit lesion
vFFR, FFR, RFR, dPR, CFR and IMR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The diagnostic performance of acute-setting vFFR for the physiological assessment of intermediate non-culprit lesions, with acute-setting FFR as the reference standard.
Time Frame: Intraprocedural (0 days)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The diagnostic performance of acute-setting vFFR for the physiological assessment of intermediate non-culprit lesions, with acute-setting RFR as the reference standard.
Time Frame: Intraprocedural (0 days)
Diagnostic performance: sensitivity, specificity, diagnostic accuracy, positive predictive value and negative predictive value (ischemic cutoff value acute-setting vFFR: ≤0.80; acute-setting RFR: ≤0.89).
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.
Time Frame: Intraprocedural (0 days)
Diagnostic performance: sensitivity, specificity, diagnostic accuracy, positive predictive value and negative predictive value (ischemic cutoff value acute-setting RFR: ≤0.89; acute-setting FFR: ≤0.80).
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.
Time Frame: Postprocedural (max. 7 days)
Diagnostic performance: sensitivity, specificity, diagnostic accuracy, positive predictive value and negative predictive value (ischemic cutoff value acute-setting vFFR: ≤0.80; offline dPR: ≤0.89).
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.
Time Frame: Postprocedural (max. 7 days)
Diagnostic performance: sensitivity, specificity, diagnostic accuracy, positive predictive value and negative predictive value (ischemic cutoff value offline vFFR: ≤0.80; acute-setting FFR: ≤0.80; acute-setting RFR: ≤0.89).
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.
Time Frame: Postprocedural (max. 7 days)
Diagnostic performance: sensitivity, specificity, diagnostic accuracy, positive predictive value and negative predictive value (ischemic cutoff value offline vFFR: ≤0.80; offline dPR: ≤0.89).
Postprocedural (max. 7 days)
The correlation between CFR and the potential discrepancies between acute-setting vFFR, FFR and RFR.
Time Frame: Intraprocedural (0 days)
The microvascular state is expressed as coronary flow reserve (CFR).
Intraprocedural (0 days)
The correlation between IMR and the potential discrepancies between acute-setting vFFR, FFR and RFR.
Time Frame: Intraprocedural (0 days)
The microvascular state is expressed as the index of microvascular resistance (IMR).
Intraprocedural (0 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasmus Medical Center

Investigators

  • Principal Investigator: Joost Daemen, MD PhD, Erasmus Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2022

Primary Completion (Anticipated)

June 22, 2023

Study Completion (Anticipated)

June 22, 2023

Study Registration Dates

First Submitted

January 16, 2023

First Submitted That Met QC Criteria

January 16, 2023

First Posted (Estimate)

January 26, 2023

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 16, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAST STEMI II

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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