This study protocol describes a randomized controlled trial to evaluate whether combining the Shexiang Baoxin pill with exercise rehabilitation improves coronary microcirculation in CTO-PCI patients.
RCT
Single-blind
Computer-generated block randomization sequence (block size = 4)
No
Does Shexiang Baoxin pill combined with exercise rehabilitation training improve coronary microcirculation and clinical outcomes in CTO-PCI patients?
This study protocol outlines a randomized controlled trial to evaluate the combined effects of Shexiang Baoxin pill and exercise rehabilitation on coronary microcirculation and clinical outcomes in patients following CTO-PCI.
Background: CTO-PCI is generally successful, but 40-55% of patients experience coronary microvascular dysfunction (CMVD) afterward, raising the risk of cardiovascular issues. Shexiang Baoxin Pill (SBP) aids angiogenesis and cardiovascular health, while exercise rehabilitation boosts coronary collateral circulation. However, the combined impact of these treatments on CTO-PCI patients remains under-researched. Methods: This prospective, single-center, randomized controlled trial involves CTO-PCI patients divided into four groups: Shexiang Baoxin pill, exercise rehabilitation, combined, and control. The exercise protocol includes pre-assessment, a three-phase prescription, CPET-based intensity grading, various exercise methods, remote monitoring, and quality control. The primary outcome is coronary microcirculation assessed by myocardial contrast echocardiography and stress myocardial perfusion imaging 1-year post-surgery. Secondary outcomes include angina incidence, major adverse cardiovascular events (MACE), quality-of-life improvements, and mechanism-related biological indicators, with safety outcomes monitoring liver and kidney function. Data will be analyzed statistically. Discussion: This study will demonstrate the positive effects of Shexiang Baoxin pill combined with exercise rehabilitation training in improving coronary microcirculatory conditions, reducing major adverse cardiovascular events, and improving quality of life in patients with CTO-PCI. The results of this study will provide new insights into the CTO-PCI patients' long-term rehabilitation. Clinical trial registration: ITMCTR2025000965, Effect of Shexiang Baoxin Pill combined with exercise rehabilitation training on the long-term prognosis of patients with CTO-PCI, Registered on 28 February, 2025.
Liu et al. (Thu,) conducted a rct in Coronary chronic total occlusion (CTO) post-PCI. Shexiang Baoxin pill combined with exercise rehabilitation vs. Routine post-PCI treatment, SBP alone, or exercise alone was evaluated on Coronary microcirculation assessed by myocardial contrast echocardiography (MCE) and stress myocardial perfusion imaging (MPI). This study protocol describes a randomized controlled trial to evaluate whether combining the Shexiang Baoxin pill with exercise rehabilitation improves coronary microcirculation in CTO-PCI patients.