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Clinical Trial
. 2018 Apr;97(16):e0443.
doi: 10.1097/MD.0000000000010443.

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

Rongchong Huang  1 , Xiantao Song, Haishan Zhang, Wen Tian, Zheng Huang, Xingwei Zhang, Junqing Yang, Dongfeng Zhang, Jian Wu, Lei Zhong, Henry H Ting; SOS-COMEDY investigators
Affiliations
Clinical Trial

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

Rongchong Huang et al. Medicine (Baltimore). 2018 Apr.

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.

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Conflict of interest statement

The authors have no conflicts of interest to disclose.

Figures

Figure 1
Figure 1
Study flow diagram outlining the study design.
Figure 2
Figure 2
The pilot study of decision aid (DA) of SOS-comedy for patients with CTO lesions both in English (A) and Chinese (B) version. CTO = chronic total occlusion, SOS = success of opening single.
See this image and copyright information in PMC

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