An observational study in ST Elevation Myocardial Infarction, Multivessel Coronary Artery Disease and Percutaneous Coronary Intervention, sponsored by Erasmus Medical Center. Status unknown at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-26.
Sponsored by Erasmus Medical Center · Observational
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.
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:
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 111 is below the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Erasmus Medical Center is the lead sponsor of 466 studies on the registry; 179 are open to participants now.
Counted across the registry records on this site, refreshed daily.
STEMI patients with multivessel disease undergoing primary percutaneous coronary intervention.
Exclusion Criteria:
vFFR, FFR, RFR, dPR, CFR and IMR
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).
Time frame: Intraprocedural (0 days)
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).
Time frame: 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.
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).
Time frame: 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.
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).
Time frame: 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.
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).
Time frame: 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.
Diagnostic performance: sensitivity, specificity, diagnostic accuracy, positive predictive value and negative predictive value (ischemic cutoff value offline vFFR: ≤0.80; offline dPR: ≤0.89).
Time frame: Postprocedural (max. 7 days)
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).
Time frame: Intraprocedural (0 days)
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).
Time frame: Intraprocedural (0 days)
Plan to share: No
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