Kretzschmar Daniel, Jung Christian, Otto Sylvia, Utschig Stephan, Hartmann Michael, Lehmann Thomas, Yilmaz Atilla, Pörner Tudor C, Figulla Hans R, Ferrari Markus
Department of Internal Medicine I, Division of Cardiology, University Hospital Jena, Erlanger Allee 101, D-07740, Jena, Germany.
Cardiovasc Ultrasound. 2012 May 21;10:21. doi: 10.1186/1476-7120-10-21.
Embolization of atherosclerotic debris from the rupture of a vulnerable atherosclerotic plaque occurs iatrogenically during percutaneous coronary interventions (PCI) and can induce myocardial necrosis. These microembolizations are detected as high intensity transient signals (HITS) using intracoronary Doppler technology.
In the presented study we will test if abciximab (ReoPro®) infusion reduces high intensity transient signals in patients with stable angina pectoris undergoing PCI in comparison to standard therapy alone.
The High Intensity Transient Signals ReoPro® (HITS-RP) study will enroll 60 patients. It is a prospective, single center, randomized, double-blinded, controlled trial. The study is designed to compare the efficacy of intravenous abciximab administration for reduction of microembolization during elective PCI. Patients will be randomized in a 1:1 fashion to abciximab or placebo infusion. The primary end point of the HITS-RP-Study is the number of HITS during PCI measured by intracoronary Doppler wire. Secondary endpoints are bleeding complications, elevation of cardiac biomarkers or ECG changes after percutaneous coronary interventions, changes in coronary flow velocity reserve, hs-CRP elevation, any major adverse cardio-vascular event during one month follow-up.
The HITS-RP-Study addresses important questions regarding the efficacy of intravenous abciximab administration in reducing microembolization and periprocedural complications in stable angina pectoris patients undergoing PCI.
The trial is registered under http://www.drks-neu.uniklinik-freiburg.de/drks_web/:DRKS00000603.
在经皮冠状动脉介入治疗（PCI）过程中，易损动脉粥样硬化斑块破裂产生的动脉粥样硬化碎片栓塞可医源性发生，并可导致心肌坏死。使用冠状动脉内多普勒技术可将这些微栓塞检测为高强度瞬态信号（HITS）。
在本研究中，我们将测试与单纯标准治疗相比，阿昔单抗（ReoPro®）输注是否能减少接受PCI的稳定型心绞痛患者的高强度瞬态信号。
高强度瞬态信号阿昔单抗（HITS-RP）研究将纳入60名患者。这是一项前瞻性、单中心、随机、双盲、对照试验。该研究旨在比较静脉注射阿昔单抗在择期PCI期间减少微栓塞的疗效。患者将以1:1的方式随机接受阿昔单抗或安慰剂输注。HITS-RP研究的主要终点是通过冠状动脉内多普勒导丝测量的PCI期间的HITS数量。次要终点是出血并发症、经皮冠状动脉介入治疗后心脏生物标志物升高或心电图变化、冠状动脉血流储备变化、hs-CRP升高、1个月随访期间的任何主要不良心血管事件。
HITS-RP研究解决了关于静脉注射阿昔单抗在减少接受PCI的稳定型心绞痛患者微栓塞和围手术期并发症方面疗效的重要问题。
该试验已在http://www.drks-neu.uniklinik-freiburg.de/drks_web/注册：DRKS00000603。
