Faculty of Medicine and Health, Charles Perkins Centre Nepean, Sydney Medical School Nepean, The University of Sydney, New South Wales, Australia; Department of Cardiology, Nepean Hospital, Sydney, New South Wales, Australia.
Faculty of Medicine and Health, Charles Perkins Centre Nepean, Sydney Medical School Nepean, The University of Sydney, New South Wales, Australia; Department of Cardiology, Nepean Hospital, Sydney, New South Wales, Australia; Department of Radiology, Nepean Hospital, Sydney, New South Wales, Australia.
Am Heart J. 2024 Sep;275:163-172. doi: 10.1016/j.ahj.2024.06.008. Epub 2024 Jun 27.
This study aims to evaluate the efficacy and cost-effectiveness of sonothrombolysis delivered pre and post primary percutaneous coronary intervention (pPCI) on infarct size assessed by cardiac MRI, in patients presenting with STEMI, when compared against sham procedure.
More than a half of patients with successful pPCI have significant microvascular obstruction and residual infarction. Sonothrombolysis is a therapeutic use of ultrasound with contrast enhancement that may improve microcirculation and infarct size. The benefits and real time physiological effects of sonothrombolysis in a multicentre setting are unclear.
The REDUCE (Restoring microvascular circulation with diagnostic ultrasound and contrast agent) trial is a prospective, multicentre, patient and outcome blinded, sham-controlled trial. Patients presenting with STEMI will be randomized to one of 2 treatment arms, to receive either sonothrombolysis treatment or sham echocardiography before and after pPCI. This tailored design is based on preliminary pilot data from our centre, showing that sonothrombolysis can be safely delivered, without prolonging door to balloon time. Our primary endpoint will be infarct size assessed on day 4±2 on Cardiac Magnetic Resonance (CMR). Patients will be followed up for 6 months post pPCI to assess secondary endpoints. Sample size calculations indicate we will need 150 patients recruited in total.
This multicentre trial will test whether sonothrombolysis delivered pre and post primary PCI can improve patient outcomes and is cost-effective, when compared with sham ultrasound delivered with primary PCI. The results from this trial may provide evidence for the utilization of sonothrombolysis as an adjunct therapy to pPCI to improve cardiovascular outcomes in STEMI. ANZ Clinical Trial Registration number: ACTRN 12620000807954.
本研究旨在评估在接受直接经皮冠状动脉介入治疗（pPCI）前后进行声溶栓治疗对 ST 段抬高型心肌梗死（STEMI）患者的梗死面积的疗效和成本效益，与假手术相比。
超过一半的 pPCI 成功患者存在明显的微血管阻塞和残余梗死。声溶栓是一种利用超声和对比剂的治疗方法，可能改善微循环和梗死面积。在多中心环境中，声溶栓的益处和实时生理效应尚不清楚。
RE- DUC-E（使用诊断超声和造影剂恢复微血管循环）试验是一项前瞻性、多中心、患者和结局盲、假对照试验。STEMI 患者将被随机分为两组，分别在 pPCI 前后接受声溶栓治疗或假超声心动图治疗。这种定制设计基于我们中心的初步试点数据，表明声溶栓可以安全地进行，而不会延长门到球囊时间。我们的主要终点将是在 pPCI 后第 4 天±2 天的心脏磁共振（CMR）评估的梗死面积。患者将在 pPCI 后 6 个月进行随访，以评估次要终点。样本量计算表明，我们总共需要招募 150 名患者。
这项多中心试验将测试在与初级 PCI 一起进行的假超声治疗相比，在初级 PCI 前后进行的声溶栓治疗是否可以改善患者的预后，并且具有成本效益。该试验的结果可能为将声溶栓作为 pPCI 的辅助治疗用于改善 STEMI 患者的心血管结局提供证据。ANZ 临床试验注册号：ACTRN 12620000807954。
