NCT07598565Toborzás még nem indult
The CORE - μFR Clinical Trial
μFR -Guided Complete Revascularization in Patients With Acute Coronary Syndromes
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. máj. 22.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 350 (tervezett)
- Első benyújtás
- 2026. máj. 4.
- Kezdés
- 2026. máj. 18.
- Elsődleges befejezés
- 2027. jún. 25.
- Fő szponzor
- University of Roma La Sapienza
- Betegségek
- Koszorúér-betegség
- NCT-szám
- NCT07598565
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 350
- 2026. máj. 18. és az elsődleges befejezés (2027. jún. 25.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Más betegség
- 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
Laborértékek
- Severely impaired renal function: creatinine \>2 mg/dl or estimated glomerular filtration rate (eGFR) \<30 ml/min/1,73 m²
Egyéb
- 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
Kiket keres a vizsgálat
- 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
Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Azienda Ospedaliero-Universitaria Sant'Andrea Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | Roma | Olaszország | Ismeretlen állapot |
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