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Randomized Controlled Trial Multicenter Study
The success of opening concurrent chronic total occlusion lesion to improve cardiac function trial in patients with multi-vessel disease (SOS-moral): Study protocol of a prospective multicenter study.
- Jinfan Tian, Huijuan Zuo, Lijun Zhang, Mingduo Zhang, Dongfeng Zhang, Min Zhang, Yuan Zhou, Yi He, Hongzhi Mi, Xueyao Yang, Rongchong Huang, Xiantao Song, and SOS-moral investigators.
- Department of Cardiology.
- Medicine (Baltimore). 2020 May 22; 99 (21): e20349.
AimsThe purpose of the present trial is to determine whether opening co-existing chronic total occlusions (CTOs) using percutaneous coronary interventions (PCIs) improves cardiac function in patients with multi-vessel disease (MVD). Patients with MVD are defined as having at least one additional major vessel exhibiting no less than 75% stenosis combined with the presence of a CTO artery.Methods And ResultsPatients will be prospectively recruited who meet the following criteria:Patients presenting with no necrosis of myocardial tissue in the territory of the CTO will be excluded. Recruited patients will be randomized into 2 groups: those undergoing PCI of only the non-CTO artery (non-CTO PCI group), and those undergoing PCI of the non-CTO artery concurrently with the CTO artery (CTO-PCI group). The primary outcome will be the change in cardiac function evaluated via CMR at a 12-month of follow-up appointment, which will be compared to a baseline measurement. Secondary outcomes include occurrence of major cardiac events, CMR-assessed myocardial viability in the CTO-supplied territory, and quality of life assessed by Seattle angina questionnaire, Patient Health Questionnaire 9 and Generalized Anxiety Disorder Scale-7 after 12-month follow-up.ConclusionThe SOS-moral trial will provide data necessary to determine whether to open concurrent CTOs among MVD patients with CMR-detected necrotic myocardial tissue.
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