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

Percutaneous Coronary Intervention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05698719
• Other study ID #: FAST STEMI II
• Status: Recruiting
• Start date: June 22, 2022
• Est. completion date: June 22, 2023

Study information

• Verified date: January 2023
• Source: Erasmus Medical Center
• Contact: Joost Daemen, MD PhD
• Phone: +31 (0)10 70 388 96
• Email: j.daemen[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 111
• Est. completion date: June 22, 2023
• Est. primary completion date: June 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Netherlands	Erasmus University Medical Center	Rotterdam
Poland	Medical University of Warsaw	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Countries where clinical trial is conducted

Netherlands,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The diagnostic performance of acute-setting vFFR for the physiological assessment of intermediate non-culprit lesions, with acute-setting RFR as the reference standard.	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)
Secondary	The diagnostic performance of acute-setting RFR 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 RFR: =0.89; acute-setting FFR: =0.80).	Intraprocedural (0 days)
Secondary	The diagnostic performance of acute-setting vFFR for the physiological assessment of intermediate non-culprit lesions, with offline dPR as the reference standard.	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)
Secondary	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.	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)
Secondary	The diagnostic performance of offline vFFR for the physiological assessment of intermediate non-culprit lesions, with offline dPR as the reference standard.	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)
Secondary	The correlation between CFR and the potential discrepancies between acute-setting vFFR, FFR and RFR.	The microvascular state is expressed as coronary flow reserve (CFR).	Intraprocedural (0 days)
Secondary	The correlation between IMR and the potential discrepancies between acute-setting vFFR, FFR and RFR.	The microvascular state is expressed as the index of microvascular resistance (IMR).	Intraprocedural (0 days)