μFR -Guided Complete Revascularization in Patients With Acute Coronary Syndromes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 350
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Complete revascularization will be performed with the operators blinded to the μFR results.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究者
Emanuele Gallinoro
Principal Investigator
University of Roma La Sapienza