Karagiannidis Efstratios, Papazoglou Andreas S, Samaras Athanasios, Nasoufidou Athina, Zormpas Georgios, Tagarakis Georgios, Theodoropoulos Konstantinos C, Papadakis Marios, Tzikas Apostolos, Fragakis Nikolaos, Kassimis George
Second Department of Cardiology, Hippokration General Hospital of Thessaloniki, Thessaloniki 54636, Greece.
Department of Cardiology, Athens Naval Hospital, Aristotle University of Thessaloniki, Thessaloniki 54636, Greece.
World J Cardiol. 2025 Apr 26;17(4):106072. doi: 10.4330/wjc.v17.i4.106072.
Safety and efficacy of intravascular ultrasound (IVUS) guidance in percutaneous coronary intervention (PCI) has been consistently shown in recent trials. However, prospective data on the clinical effects of IVUS usage in primary PCI are still warranted. The ULTRA-STEMI trial is a prospective investigator-initiated observational single-center cohort trial aiming to enroll 80 patients with STEMI.
To investigate the outcomes of patients with STEMI undergoing IVUS-guided PCI and correlate derived IVUS measurements with clinical, procedural, imaging and follow-up outcomes of interest.
Study participants will undergo primary PCI as per standardized procedures. IVUS pullbacks will be performed pre-intervention, post-lesion preparation, post-intervention and post-optimization using a 20 MHz digital IVUS (Eagle Eye Platinum, Philips). Manual thrombus aspiration will be performed in cases of high thrombus burden. The aspirated thrombi will be scanned with micro-computed tomography to extract volumetric measurements of the aspirated thrombotic burden. Moreover, angiographic, peri-procedural and 3-year follow-up data will be gathered. Co-primary endpoints will be cardiovascular mortality and target vessel failure, defined as the composite of: Cardiovascular mortality, target vessel myocardial infarction and/or clinically driven target vessel revascularization.
The results of the study are expected by the third quarter of 2029.
The ULTRA-STEMI trial will add to the existing literature the clinical, angiographic, micro-computed tomography and follow-up outcomes of IVUS-guided PCI in 80 patients presenting with STEMI.
近期试验一致表明血管内超声（IVUS）指导在经皮冠状动脉介入治疗（PCI）中的安全性和有效性。然而，关于IVUS在直接PCI中临床效果的前瞻性数据仍有必要获取。ULTRA-STEMI试验是一项由研究者发起的前瞻性单中心观察性队列试验，旨在纳入80例ST段抬高型心肌梗死（STEMI）患者。
研究接受IVUS指导的PCI的STEMI患者的预后，并将IVUS测量结果与感兴趣的临床、手术、影像学和随访结果相关联。
研究参与者将按照标准化程序接受直接PCI。在干预前、病变预处理后、干预后和优化后，使用20MHz数字IVUS（飞利浦鹰眼铂晶）进行IVUS回撤。血栓负荷高的病例将进行手动血栓抽吸。抽吸的血栓将用微型计算机断层扫描进行扫描，以提取抽吸血栓负荷的体积测量值。此外，还将收集血管造影、围手术期和3年随访数据。共同主要终点将是心血管死亡率和靶血管失败，定义为以下各项的综合：心血管死亡率、靶血管心肌梗死和/或临床驱动的靶血管血运重建。
预计该研究结果将于2029年第三季度得出。
ULTRA-STEMI试验将为现有文献增添80例STEMI患者接受IVUS指导的PCI的临床、血管造影、微型计算机断层扫描和随访结果。
