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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STEMI patients undergoing physiological assessment of a non-culprit lesion | vFFR, FFR, RFR, dPR, CFR and IMR |
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| 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. | 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) |
| 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. | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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STEMI patients with multivessel disease undergoing primary percutaneous coronary intervention.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Joost Daemen, MD PhD | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus University Medical Center | Recruiting | Rotterdam | 3015GD | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40924133 | Derived | 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. |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| C535374 | Dermatopathia pigmentosa reticularis |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| Medical University of Warsaw | Not yet recruiting | Warsaw | Poland |
|
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |