Department of Cardiology, VU University Medical Center, Amsterdam, The Netherlands.
Ultrasound Med Biol. 2012 Feb;38(2):247-52. doi: 10.1016/j.ultrasmedbio.2011.11.001. Epub 2011 Dec 16.
In animal studies, transthoracic ultrasound and microbubbles have shown to dissolve thrombi in ST elevation myocardial infarction (STEMI). To examine this effect in patients, we have initiated the Sonolysis trial. In this pilot study of 10 patients with a first acute STEMI, we investigated the safety and feasibility of this trial. After pretreatment in the ambulance, five patients were randomized to receive microbubbles with three-dimensional (3-D) guided high mechanical index impulses (1.18) for 15 min, whereas the control group received placebo without ultrasound. Subsequently, primary percutaneous coronary intervention (PPCI) was performed, if indicated. All patients successfully underwent study treatment and PPCI. No significant difference between treatment and control group in safety (minor adverse events 2/5 vs. 2/5, p = NS) and outcome (TIMI III flow 3/5 vs. 1/5 respectively, p = 0.23) was recorded. These results demonstrate that the study protocol is feasible in the acute cardiac care setting and safe during treatment and follow-up.
在动物研究中，经胸超声和微泡已被证明可溶解 ST 段抬高型心肌梗死（STEMI）中的血栓。为了在患者中检验这种效果，我们启动了 Sonolysis 试验。在这项针对 10 名首次急性 STEMI 患者的初步研究中，我们研究了该试验的安全性和可行性。在救护车中的预处理后，5 名患者随机接受三维（3-D）引导的高强度机械指数脉冲（1.18）治疗 15 分钟，而对照组则接受无超声的安慰剂。随后，如果需要，进行经皮冠状动脉介入治疗（PPCI）。所有患者均成功完成了研究治疗和 PPCI。治疗组和对照组在安全性（轻微不良事件分别为 2/5 和 2/5，p = NS）和结果（TIMI III 血流分别为 3/5 和 1/5，p = 0.23）方面无显著差异。这些结果表明，该研究方案在急性心脏护理环境中是可行的，并且在治疗和随访期间是安全的。
