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NCT Number: NCT07598565

The CORE - μFR Clinical Trial

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.

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Key information

Conditions

Acute Coronary Syndromes (ACS) Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Infarction Ischemia Multivessel Coronary Artery Disease Myocardial Infarction Myocardial Ischemia NSTEMI - Non-ST-Segment Elevation Myocardial Infarction Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction STEMI - ST Elevation Myocardial Infarction Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Angiography-guided PCI

Procedure

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

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

Primary outcomes

  1. Primary efficacy endpoint

    Time frame: Periprocedural

    Number of stents implanted and number of procedures

  2. 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)

Secondary outcomes

  1. Inappropriate revascularization

    Time frame: Periprocedural

    Inappropriate revascularization according to μFR value

  2. Change in clinical decision making

    Time frame: Periprocedural

    Change in clinical decision making about revascularization strategy from intended PCI to medical therapy

  3. μFR reproducibility

    Time frame: Periprocedural

    Test-re-test repeatability of μFR

  4. Length of stay

    Time frame: Periprocedural

    Duration of hospitalization

Study contacts

Contact information is provided by the study sponsor or research team.

Emanuele Barbato, MD, PhD

CONTACT

[email protected]

+39 06 3377 6115

Emanuele Gallinoro, MD, PhD

CONTACT

[email protected]

+39 06 3377 5005

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

μFR -Guided Complete Revascularization in Patients With Acute Coronary Syndromes

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 20, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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