Acute Coronary Syndromes (ACS)NCT07598565
The CORE - μFR Clinical Trial
A study testing Angiography-guided PCI and μFR based-PCI in people with Acute Coronary Syndromes (ACS) and NSTEMI - Non-ST-Segment Elevation Myocardial Infarction, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
Acute coronary syndromes (ACS) are frequently associated with multivessel coronary artery disease (CAD), and current guidelines recommend complete revascularization beyond the culprit lesion. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Coronary Syndromes (ACS), NSTEMI - Non-ST-Segment Elevation Myocardial Infarction, STEMI - ST Elevation Myocardial Infarction
- What is being tested?
- Angiography-guided PCI and μFR based-PCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteItaly
- Study dates
- 18 May 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients presenting with ACS within 72 hours of successful culprit PCI
- Residual coronary artery disease, defined as at least one additional stenosis in any non-culprit vessel (NCV) with the following characteristics:
- at least 50% diameter stenosis by visual assessment
- a vessel diameter of at least 2.5 mm
- amenable to successful PCI
Who cannot join
- Cardiogenic shock or severe heart failure (NYHA class ≥III)
- Severely impaired renal function: creatinine >2 mg/dl or estimated glomerular filtration rate (eGFR) <30 ml/min/1,73 m²
- Allergy to iodine-containing contrast agents which cannot be adequately pre-medicated
- Pregnancy or intention to become pregnant during the trial
- Life expectancy less than one year
- Ambiguity in the identification of the culprit vessel/lesion
Show all 16Show fewer
- Clinical presentation as myocardial infarction and non-obstructive coronary artery disease (MINOCA) and/or Tako-Tsubo Syndrome
- Any ambiguity in the diagnosis of ACS
- Inability to provide informed consent
- Patients with only one coronary artery lesion with diameter stenosis >90% and/or TIMI flow <3
- Patients in whom the NCV is treated at the time of the index procedure
- An interrogated lesion is at the site of a myocardial bridge
- An interrogated lesion is a culprit lesion responsible for the acute myocardial infarction
- An interrogated lesion is in a bypass graft
- Poor angiographic image quality precluding vessel contour detection or with suboptimal contrast opacification
- Severe vessel overlap in the stenosed segment or severe tortuosity of any interrogated vessel deemed not amenable to μFR measurement
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Azienda ospedaliero - universitaria Sant'Andrea
Roma, RM, 00189
Emanuele Barbato, MD, PhD, +39 06 3377 6115, emanuele.barbato@uniroma1.it
Emanuele Gallinoro, MD, PhD, +39 06 3377 5005, egallinoro@gmail.com
About this study
Official title: μFR -Guided Complete Revascularization in Patients With Acute Coronary Syndromes
Acute coronary syndromes (ACS) are frequently associated with multivessel coronary artery disease (CAD), and current guidelines recommend complete revascularization beyond the culprit lesion. Angiography-guided PCI is the standard approach, but anatomical assessment does not always reflect the functional significance of intermediate lesions, while FFR-guided strategies are limited by the need for pressure wires and hyperemia. Murray-law-based quantitative flow ratio (μFR) is a wire-free angiography-derived physiological index that may improve decision-making for revascularization in ACS patients.
The Core-μFR is an investigator-driven, multicenter, randomized, open-label and prospective trial designed to evaluate whether μFR can act as a gatekeeper for complete revascularization in patients with ACS and multivessel disease by identifying non-culprit lesions that truly require PCI.
Patients with ACS (either STEMI or NSTE-ACS) undergoing primary PCI will be considered eligible if they present multivessel CAD on visual assessment with the intention to treat the non-culprit vessel in a staged procedure within the same hospitalization. After the pPCI, eligible patients will be randomized to either group A or group B and μFR will be performed in a blinded fashion with the operator unaware of the functional result. Patients in group A will undergo a staged PCI of all NCVs guided by coronary angiography, as per standard of care. In group B, μFR will be used as a gatekeeper for staged revascularization. Operators will only be informed whether at least one non-culprit vessel is μFR-positive, without disclosure of the specific vessel involved or the μFR values. If at least one non-culprit vessel has μFR ≤0.80, patients will undergo angiography-guided PCI of all non-culprit vessels previously deemed suitable for treatment by visual assessment. If μFR is >0.80 in all non-culprit vessels, staged PCI will be deferred and the patient will be discharged without further revascularization. Finally, to test the functional reproducibility, a blinded post-hoc μFR assessment will be performed on the baseline angiograms of the staged procedures in all the patients undergoing complete revascularization. Clinical follow-up will be performed at 30 days and 1 year from randomization.
- Conditions
- Acute Coronary Syndromes (ACS), NSTEMI - Non-ST-Segment Elevation Myocardial Infarction, STEMI - ST Elevation Myocardial Infarction, Multivessel Coronary Artery Disease
- Being tested
- Angiography-guided PCI, μFR based-PCI
- Keywords
- Murray-law based Quantitative Flow Ratio (μFR), Non culprit vessel, Revascularization
- Medical subject headings
- Acute Coronary Syndrome, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiography-guided PCIProcedure or surgery
staged PCI of all NCVs will be performed as per standard of care
μFR based-PCIProcedure or surgery
staged PCI will be deferred if the μFR > 0.80 in all the NCVs or performed if the μFR is ≤ 0.80 in at least one NCVs
| Study group | Role | What they receive |
|---|---|---|
| Group A - Angiography-guided PCI (standard strategy) | Active comparator | Patients will undergo a staged PCI of all non-culprit vessels identified before randomization according to angiography and operator judgment, as per standard of care. μFR will be analyzed off-line by the core lab and will not be available to the operator. Receives: Procedure: Angiography-guided PCI |
| Group B - μFR based-PCI | Experimental | μFR will be analyzed off-line by the core lab. Coronary revascularization will be deferred if the μFR > 0.80 in all the non-culprit vessels identified before randomization. If μFR ≤ 0.80 in at least one non-culprit vessels identified before randomization, patients will undergo a staged PCI. Operators remain blinded to μFR values, and treatment of vessels is based on angiography only. Receives: Procedure: μFR based-PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy endpoint
Number of stents implanted and number of procedures
Measured: Periprocedural
Primary safety endpoint
MACE (major adverse cardiovascular event) defined as the composite of all-cause mortality, non-culprit vessel unplanned revascularization, non-fatal myocardial infarction (defined according to the Fourth Universal Definition of Myocardial Infarction, including procedural MI and spontaneous MI)
Measured: 1 year
Secondary outcomes (4)
Inappropriate revascularization
Inappropriate revascularization according to μFR value
Measured: Periprocedural
Change in clinical decision making
Change in clinical decision making about revascularization strategy from intended PCI to medical therapy
Measured: Periprocedural
μFR reproducibility
Test-re-test repeatability of μFR
Measured: Periprocedural
Length of stay
Duration of hospitalization
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start18 May 2026 (estimated)
- Primary completion25 Jun 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary Syndromes (ACS)Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emanuele Gallinoro, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07598565
- Sponsor's protocol ID
- Rif. 8306, Prot. 0284/2026
- Status last verified
- May 2026
- First submitted
- 4 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- μFR -Guided Complete Revascularization in Patients With Acute Coronary Syndromes
- ClinicalTrials.gov ID
- NCT07598565
- Acronym / sponsor ID
- Rif. 8306, Prot. 0284/2026
- Conditions
- Acute Coronary Syndromes (ACS), NSTEMI - Non-ST-Segment Elevation Myocardial Infarction, STEMI - ST Elevation Myocardial Infarction, Multivessel Coronary Artery Disease
- Keywords
- Murray-law based Quantitative Flow Ratio (μFR), Non culprit vessel, Revascularization
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 18 May 2026 (estimated)
- Primary completion
- 25 Jun 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 20 May 2026 (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.
Acute coronary syndromes (ACS) are frequently associated with multivessel coronary artery disease (CAD), and current guidelines recommend complete revascularization beyond the culprit lesion. Angiography-guided PCI is the standard approach, but anatomical assessment does not always reflect the functional significance of intermediate lesions, while FFR-guided strategies are limited by the need for pressure wires and hyperemia. Murray-law-based quantitative flow ratio (μFR) is a wire-free angiography-derived physiological index that may improve decision-making for revascularization in ACS patients.
The Core-μFR is an investigator-driven, multicenter, randomized, open-label and prospective trial designed to evaluate whether μFR can act as a gatekeeper for complete revascularization in patients with ACS and multivessel disease by identifying non-culprit lesions that truly require PCI.
Patients with ACS (either STEMI or NSTE-ACS) undergoing primary PCI will be considered eligible if they present multivessel CAD on visual assessment with the intention to treat the non-culprit vessel in a staged procedure within the same hospitalization. After the pPCI, eligible patients will be randomized to either group A or group B and μFR will be performed in a blinded fashion with the operator unaware of the functional result. Patients in group A will undergo a staged PCI of all NCVs guided by coronary angiography, as per standard of care. In group B, μFR will be used as a gatekeeper for staged revascularization. Operators will only be informed whether at least one non-culprit vessel is μFR-positive, without disclosure of the specific vessel involved or the μFR values. If at least one non-culprit vessel has μFR ≤0.80, patients will undergo angiography-guided PCI of all non-culprit vessels previously deemed suitable for treatment by visual assessment. If μFR is >0.80 in all non-culprit vessels, staged PCI will be deferred and the patient will be discharged without further revascularization. Finally, to test the functional reproducibility, a blinded post-hoc μFR assessment will be performed on the baseline angiograms of the staged procedures in all the patients undergoing complete revascularization. Clinical follow-up will be performed at 30 days and 1 year from randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - Angiography-guided PCI (standard strategy) | Active comparator | Procedure: Angiography-guided PCIPatients will undergo a staged PCI of all non-culprit vessels identified before randomization according to angiography and operator judgment, as per standard of care. μFR will be analyzed off-line by the core lab and will not be available to the operator. |
| Group B - μFR based-PCI | Experimental | Procedure: μFR based-PCIμFR will be analyzed off-line by the core lab. Coronary revascularization will be deferred if the μFR > 0.80 in all the non-culprit vessels identified before randomization. If μFR ≤ 0.80 in at least one non-culprit vessels identified before randomization, patients will undergo a staged PCI. Operators remain blinded to μFR values, and treatment of vessels is based on angiography only. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients presenting with ACS within 72 hours of successful culprit PCI
- Residual coronary artery disease, defined as at least one additional stenosis in any non-culprit vessel (NCV) with the following characteristics:
Key exclusion criteria (16 listed)
- Cardiogenic shock or severe heart failure (NYHA class ≥III)
- Severely impaired renal function: creatinine >2 mg/dl or estimated glomerular filtration rate (eGFR) <30 ml/min/1,73 m²
- Allergy to iodine-containing contrast agents which cannot be adequately pre-medicated
- Pregnancy or intention to become pregnant during the trial
- Life expectancy less than one year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Angiography-guided PCIstaged PCI of all NCVs will be performed as per standard of care | Procedure or surgery | Group A - Angiography-guided PCI (standard strategy) |
| μFR based-PCIstaged PCI will be deferred if the μFR > 0.80 in all the NCVs or performed if the μFR is ≤ 0.80 in at least one NCVs | Procedure or surgery | Group B - μFR based-PCI |
Primary outcome
Primary efficacy endpoint
Time frame: Periprocedural
Number of stents implanted and number of procedures
Primary safety endpoint
Time frame: 1 year
MACE (major adverse cardiovascular event) defined as the composite of all-cause mortality, non-culprit vessel unplanned revascularization, non-fatal myocardial infarction (defined according to the Fourth Universal Definition of Myocardial Infarction, including procedural MI and spontaneous MI)
4 secondary outcomes
Inappropriate revascularization
Time frame: Periprocedural
Change in clinical decision making
Time frame: Periprocedural
μFR reproducibility
Time frame: Periprocedural
Length of stay
Time frame: Periprocedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Angiography-guided PCI and μFR based-PCI in people with Acute Coronary Syndromes (ACS) and NSTEMI - Non-ST-Segment Elevation Myocardial Infarction, run by University of Roma La Sapienza at 1 site in Italy.
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 5 inclusion and 16 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: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emanuele Barbato, MD, PhD (+39 06 3377 6115, emanuele.barbato@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary efficacy endpoint (time frame: Periprocedural). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2026.