The CORE - μFR Clinical Trial

NCT07598565 | Not Yet Recruiting

• 1 other identifier: Rif. 8306, Prot. 0284/2026
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

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 that aims 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 by visual assessment with the intention to treat the non-culprit vessel in a staged procedure within the same hospitalization. After the pPCI, the patient deemed eligible 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 coronary revascularization will be deferred if the μFR \> 0.80 in all the NCV. If μFR ≤ 0.80 in at least one NCV, patients will undergo angiography-guided PCI as per standard of care. In both groups, complete revascularization will be performed with the operators blinded to the μFR results. 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

Keywords

Murray-law based Quantitative Flow Ratio (μFR); Non culprit vessel; Revascularization

Outcome Measures

Primary Outcomes (2)

• Primary efficacy endpoint

  Number of stents implanted and number of procedures

  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)

  1 year

Secondary Outcomes (4)

• Inappropriate revascularization

  Periprocedural

• Change in clinical decision making

  Periprocedural

• μFR reproducibility

  Periprocedural

• Length of stay

  Periprocedural

Study Arms (2)

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.

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.

Procedure: μFR based-PCI

Interventions

Angiography-guided PCI PROCEDURE

staged PCI of all NCVs will be performed as per standard of care

Group A - Angiography-guided PCI (standard strategy)

μFR based-PCI PROCEDURE

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

Group B - μFR based-PCI

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 of successful PCI

You may not qualify if:

• Cardiogenic shock or severe heart failure (NYHA class ≥III)
• Severely impaired renal function: creatinine \>2 mg/dl or estimated glomerular filtration rate (GFR) \<30 ml/kg/1·73 m2 (calculated with Cockcroft-Gault formula)
• 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
• Clinical presentation as myocardial infarction and non-obstructive coronary artery disease (MINOCA) and /or Tako-Tsubo Sndrome
• Any ambiguity in the diagnosis of ACS
• Inability to provide informed consent
• Patients with only one coronary artery lesion with diameter stenosis \>90% with 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 related to acute myocardial infarction
• An interrogated lesion is in a bypass graft
• Poor angiographic image quality precluding vessel contour detection or with suboptimal contrast opacification

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Azienda ospedaliero - universitaria Sant'Andrea

Roma, RM, 00189, Italy

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Central Study Contacts

Emanuele Barbato, MD, PhD

CONTACT

+39 06 3377 6115; emanuele.barbato@uniroma1.it

Emanuele Gallinoro, MD, PhD

CONTACT

+39 06 3377 5005; egallinoro@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Complete revascularization will be performed with the operators blinded to the μFR results.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 20, 2026
• Study Start: May 18, 2026
• Primary Completion (Estimated): June 25, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 20, 2026

Record last verified: 2026-05

Locations

IT (1)