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开通单一慢性完全闭塞病变以改善心肌存活性试验(SOS-COMEDY)的成功:一项前瞻性多中心研究的研究方案

The success of opening single chronic total occlusion lesions to improve myocardialviabilitytrial (SOS-COMEDY): Study protocol of a prospective multicenter study.

作者信息

Huang Rongchong, Song Xiantao, Zhang Haishan, Tian Wen, Huang Zheng, Zhang Xingwei, Yang Junqing, Zhang Dongfeng, Wu Jian, Zhong Lei, Ting Henry H

机构信息

The Department of Cardiology, The First Affiliated Hospital of Dalian Medical University, Dalian City The Department of Cardiology, Beijing An Zhen Hospital, Capital Medical University, Beijing City The Department of Cardiology, First Affiliated Hospital of China Medical University, Shenyang City The Department of Cardiology, Southern Hospital, Southern Medical University, Guangzhou City The Department of Cardiology, The Affiliated Hospital of Hangzhou Normal University, Hangzhou City The Department of Cardiology, Guangdong General Hospital, Guangzhou City, China Division of Cardiology, Mayo Clinic, Jacksonville, FL.

出版信息

Medicine (Baltimore). 2018 Apr;97(16):e0443. doi: 10.1097/MD.0000000000010443.

DOI:10.1097/MD.0000000000010443
PMID:29668609
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5916680/
Abstract

AIMS

Success of opening single (SOS)-comedy is a prospective multicenter study to compare the improvement in the decrease of myocardial viability by percutaneous coronary intervention (PCI) with that by optimal medical therapy (OMT) alone in patients with chronic total occlusion (CTO) of a single coronary artery.

METHODS AND RESULTS

The risks and the benefits of both options (PCI and OMT) were listed in a CTO decision aid (DA). Eligible participants detected by invasive coronary angiography (ICA) or coronary computed tomography angiography (CCTA) were divided into PCI or OMT groups according to patients' choice after shared-decision making process with DA. Participants will undergo positron emission tomography/computed tomography (PET/CT), cardiac magnetic resonance (CMR) and transthoracic echocardiography (TTE), and proceed to ICA and revascularization if possible. Blinded core laboratory interpretation will be performed for ICA, CCTA, PET/CT, CMR, and TTE. All participants will be followed up for 12 months. The primary endpoint is the improvement to the decrease of myocardial viability from baseline assessed with the use of PET/CT after 12-month follow-up.

CONCLUSIONS

All of the patients are appropriately consented before enrolling in this study, which has been approved by the Ethics Committee. Results of SOS-COMEDY will be helpful to develop a strategy for single CTO patients.

摘要

目的

单支血管开通(SOS)-喜剧研究是一项前瞻性多中心研究,旨在比较经皮冠状动脉介入治疗(PCI)与单纯优化药物治疗(OMT)对单支冠状动脉慢性完全闭塞(CTO)患者心肌存活性降低的改善情况。

方法与结果

两种治疗方案(PCI和OMT)的风险和益处列于CTO决策辅助工具(DA)中。通过有创冠状动脉造影(ICA)或冠状动脉计算机断层扫描血管造影(CCTA)检测出的符合条件的参与者,在与DA进行共同决策过程后,根据患者选择分为PCI组或OMT组。参与者将接受正电子发射断层扫描/计算机断层扫描(PET/CT)、心脏磁共振成像(CMR)和经胸超声心动图(TTE)检查,如有可能,进行ICA和血运重建。将对ICA、CCTA、PET/CT、CMR和TTE进行盲法核心实验室解读。所有参与者将接受12个月的随访。主要终点是随访12个月后,使用PET/CT评估的心肌存活性较基线降低情况的改善。

结论

所有患者在入组本研究前均已获得适当知情同意,本研究已获得伦理委员会批准。SOS-COMEDY的结果将有助于制定单支CTO患者的治疗策略。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f8d5/5916680/1ac67ccc9888/medi-97-e0443-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f8d5/5916680/d6a934ba4c97/medi-97-e0443-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f8d5/5916680/1ac67ccc9888/medi-97-e0443-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f8d5/5916680/d6a934ba4c97/medi-97-e0443-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f8d5/5916680/1ac67ccc9888/medi-97-e0443-g002.jpg

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Effects of successful percutaneous coronary intervention of chronic total occlusions on myocardial perfusion and left ventricular function.慢性完全闭塞病变经皮冠状动脉介入治疗对心肌灌注和左心室功能的影响。
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Optimal medical therapy may be a better initial strategy in patients with chronic total occlusion of a single coronary artery.
对于单支冠状动脉慢性完全闭塞的患者,优化药物治疗可能是更好的初始策略。
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