NCT07598565Not yet recruiting
The CORE - μFR Clinical Trial
μFR -Guided Complete Revascularization in Patients With Acute Coronary Syndromes
Source: ClinicalTrials.gov · Last updated 22 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 350 (estimated)
- First submitted
- 4 May 2026
- Start date
- 18 May 2026
- Primary completion date
- 25 Jun 2027
- Lead sponsor
- University of Roma La Sapienza
- Diseases
- Coronary artery disease
- NCT number
- NCT07598565
What you commit to
- Study type: Interventional
- Planned participants: 350
- From 18 May 2026 to the primary completion date, 25 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Cardiogenic shock or severe heart failure (NYHA class ≥III)
- Allergy to iodine-containing contrast agents which cannot be adequately pre-medicated
- Clinical presentation as myocardial infarction and non-obstructive coronary artery disease (MINOCA) and/or Tako-Tsubo Syndrome
- An interrogated lesion is at the site of a myocardial bridge
- An interrogated lesion is a culprit lesion responsible for the acute myocardial infarction
Lab values
- Severely impaired renal function: creatinine \>2 mg/dl or estimated glomerular filtration rate (eGFR) \<30 ml/min/1,73 m²
Other
- Pregnancy or intention to become pregnant during the trial
- Life expectancy less than one year
- Ambiguity in the identification of the culprit vessel/lesion
- 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 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
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Azienda Ospedaliero-Universitaria Sant'Andrea Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.