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EECP intervention and coronary flow reserve in chronic coronary syndrome: a protocol of a multicentre, randomised controlled study in China (ECP-Core Trial)

作者:Yanlong Leng, Yuan Li, Jia Xue, Shuai Tian, Yundan Jiang, Ling Lin, Yinfen Wang, Wei Pan, Jianwen Liang, Fensheng Wu, Wenjuan Zhou, Zhijuan Liao, Xinxia Zhang, Guifu Wu · 发表于:Trials · 年份:2026 · DOI:10.1186/s13063-026-09878-y · 研究领域:Pain Management and Treatment、Coronary Interventions and Diagnostics、Cardiac Imaging and Diagnostics

Abstract Background The goal of chronic coronary syndrome (CCS) treatment is to improve the function of coronary arteries affected by lesions. Over the past 30 years, enhanced external counterpulsation (EECP) has been widely accepted and recommended for treating CCS in clinical guidelines. However, the effect of EECP on coronary function still requires quantitative validation. Fractional flow reserve (FFR) is a gold standard (quantitative index) of coronary artery function, and FFR < 0.80 is regarded as an indicator for percutaneous coronary intervention (PCI) in clinical decision-making. However, FFR is an invasive examination, and the interval between the two tests is too short; therefore, FFR is not suitable for large-scale verification of the effect before and after EECP treatment. Conversely, with advancements in numerical theory and computation hardware, FFR derived from coronary computed tomography angiography (FFR CT ) performs similarly to FFR used in coronary artery function measurement. Additionally, FFR CT is non-invasive and highly acceptable to patients. Therefore, in this study, we aim to explore whether EECP therapy can improve FFR CT in patients with CCS, and further enhance the long-term prognosis of CCS. Methods This prospective, multicentre, randomised controlled trial is blinded to the examination executors and analysts. 118 participants will be recruited, and they will be divided into the EECP and control groups. The primary outcome of this stu...