ST Elevation Myocardial InfarctionNCT05698719
Validation of vFFR as Compared to FFR to Guide Revascularization of Non-culprit Lesions in STEMI Patients
An observational study of ST Elevation Myocardial Infarction and Multivessel Coronary Artery Disease, run by Erasmus Medical Center at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST Elevation Myocardial Infarction, Multivessel Coronary Artery Disease, Percutaneous Coronary Intervention
- How many people
- 111 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 22 Jun 2022to 22 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: STEMI patients with multivessel disease undergoing primary percutaneous coronary intervention.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus University Medical Center
Rotterdam, 3015GD
Joost Daemen, MD PhD, +31(0)107035260, j.daemen@erasmusmc.nl
Poland1 site, 1 recruiting
- Not yet recruiting
Medical University of Warsaw
Warsaw
Mariusz Tomaniak, MD PhD
About this study
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
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.
Read the 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:
- 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.
- 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.
- 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
- Keywords
- Pressure wire-based coronary physiology (FFR, RFR, dPR), Angiography-based coronary physiology (vFFR)
- Medical subject headings
- ST Elevation Myocardial Infarction, Dermatopathia pigmentosa reticularis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| STEMI patients undergoing physiological assessment of a non-culprit lesion | vFFR, FFR, RFR, dPR, CFR and IMR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Intraprocedural (0 days)
Secondary outcomes (7)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Intraprocedural (0 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start22 Jun 2022
- Primary completion22 Jun 2023 (estimated)
- Study completion22 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joost Daemen, Erasmus Medical Center
- Investigators
- Joost Daemen, MD PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05698719
- Sponsor's protocol ID
- FAST STEMI II
- Status last verified
- Jan 2023
- First submitted
- 16 Jan 2023
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 40924133
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05698719
- Acronym / sponsor ID
- FAST STEMI II
- Conditions
- ST Elevation Myocardial Infarction, Multivessel Coronary Artery Disease, Percutaneous Coronary Intervention
- Keywords
- Pressure wire-based coronary physiology (FFR, RFR, dPR), Angiography-based coronary physiology (vFFR)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- 22 Jun 2023 (estimated)
- Study completion
- 22 Jun 2023 (estimated)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- To study the impact of CFR and IMR on the potential discrepancies between acute-setting vFFR, FFR and RFR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STEMI patients undergoing physiological assessment of a non-culprit lesion | – | –vFFR, FFR, RFR, dPR, CFR and IMR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- STEMI patients with multivessel disease undergoing primary percutaneous coronary intervention.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
7 secondary outcomes
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)
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)
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)
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)
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)
The correlation between CFR and the potential discrepancies between acute-setting vFFR, FFR and RFR.
Time frame: Intraprocedural (0 days)
The correlation between IMR and the potential discrepancies between acute-setting vFFR, FFR and RFR.
Time frame: Intraprocedural (0 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Derived from this study: PubMed 40924133van 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joost Daemen, MD PhD principal investigator
Erasmus Medical Center
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ST Elevation Myocardial Infarction and Multivessel Coronary Artery Disease, run by Erasmus Medical Center at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joost Daemen, MD PhD (+31 (0)10 70 388 96, j.daemen@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05698719, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.