Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

The CORE - μFR Clinical Trial

19. maj 2026 opdateret af: Emanuele Gallinoro, University of Roma La Sapienza

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

350

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Italien
    • RM
      • Roma, RM, Italien, 00189
        • Azienda ospedaliero - universitaria Sant'Andrea
        • Kontakt:
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Patients presenting with ACS within 72 hours of successful culprit PCI

  2. Residual coronary artery disease, defined as at least one additional stenosis in any non-culprit vessel (NCV) with the following characteristics:

    1. at least 50% diameter stenosis by visual assessment
    2. a vessel diameter of at least 2.5 mm
    3. amenable to successful PCI

Exclusion Criteria:

  1. Cardiogenic shock or severe heart failure (NYHA class ≥III)
  2. Severely impaired renal function: creatinine >2 mg/dl or estimated glomerular filtration rate (eGFR) <30 ml/min/1,73 m²
  3. Allergy to iodine-containing contrast agents which cannot be adequately pre-medicated
  4. Pregnancy or intention to become pregnant during the trial
  5. Life expectancy less than one year
  6. Ambiguity in the identification of the culprit vessel/lesion
  7. Clinical presentation as myocardial infarction and non-obstructive coronary artery disease (MINOCA) and/or Tako-Tsubo Syndrome
  8. Any ambiguity in the diagnosis of ACS
  9. Inability to provide informed consent
  10. Patients with only one coronary artery lesion with diameter stenosis >90% and/or TIMI flow <3
  11. Patients in whom the NCV is treated at the time of the index procedure
  12. An interrogated lesion is at the site of a myocardial bridge
  13. An interrogated lesion is a culprit lesion responsible for the acute myocardial infarction
  14. An interrogated lesion is in a bypass graft
  15. Poor angiographic image quality precluding vessel contour detection or with suboptimal contrast opacification
  16. Severe vessel overlap in the stenosed segment or severe tortuosity of any interrogated vessel deemed not amenable to μFR measurement

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Group A - Angiography-guided PCI (standard strategy)
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
staged PCI of all NCVs will be performed as per standard of care
Eksperimentel: Group B - μFR based-PCI
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
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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Primary efficacy endpoint
Tidsramme: Periprocedural
Number of stents implanted and number of procedures
Periprocedural
Primary safety endpoint
Tidsramme: 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)
1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Inappropriate revascularization
Tidsramme: Periprocedural
Inappropriate revascularization according to μFR value
Periprocedural
Change in clinical decision making
Tidsramme: Periprocedural
Change in clinical decision making about revascularization strategy from intended PCI to medical therapy
Periprocedural
μFR reproducibility
Tidsramme: Periprocedural
Test-re-test repeatability of μFR
Periprocedural
Length of stay
Tidsramme: Periprocedural
Duration of hospitalization
Periprocedural

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Roma La Sapienza

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

18. maj 2026

Primær færdiggørelse (Anslået)

25. juni 2027

Studieafslutning (Anslået)

30. juni 2028

Datoer for studieregistrering

Først indsendt

4. maj 2026

Først indsendt, der opfyldte QC-kriterier

13. maj 2026

Først opslået (Faktiske)

20. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Rif. 8306, Prot. 0284/2026

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Multikar koronararteriesygdom

  • IRCCS Policlinico S. Donato
    Rekruttering
    Anomal aorta-oprindelse af koronararterie (AAOCA)
    Anomalous aorta origin of the coronary artery (AAOCA)
    Italien
  • IRCCS Policlinico S. Donato
    University of Pavia; University of Naples; The Mediterranean Institute for...
    Rekruttering
    Fremskynd diagnosticering og evaluering af anomaløs kranspulsåre fra aorta (SMART)
    Myokardieiskæmi | Pludselig hjertedød | Anomal koronararterieoprindelse | Anomal koronararterie, der opstår fra den modsatte sinus | Anomal koronararterie med aorta-oprindelse og forløb mellem de store arterier | Anomalous aorta origin of the coronary artery (AAOCA) | Myokardieiskæmi, Angina Pectoris og andre forhold
    Italien

Kliniske forsøg med Angiography-guided PCI

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Austria

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner