STUDY PROTOCOL article
Front. Med.
Sec. Family Medicine and Primary Care
Volume 12 - 2025 | doi: 10.3389/fmed.2025.1668432
This article is part of the Research TopicChallenges and Innovations in Healthcare Management and Long-Term Care for an Aging SocietyView all 30 articles
Effects of Shexiang Baoxin Pill combined with exercise rehabilitation training on long-term prognosis of CTO-PCI patients: study protocol for randomized controlled trial
Provisionally accepted
- 1Hebei Medical University, Shijiazhuang, China
- 2Hebei University of Chinese Medicine, Shijiazhuang, China
- 3The 980th Hospital of the Chinese PLA Joint Logistics Support Force, Shijiazhuang, China
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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 one-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. 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.
Keywords: coronary chronic total occlusion (CTO), Coronary microvascular dysfunction (CMVD), Shexiang Baoxin pill (SBP), Exercise rehabilitation, Long-term prognosis
Received: 18 Jul 2025; Accepted: 09 Oct 2025.
Copyright: © 2025 Liu, Liang, Guo and Zhao. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Yuying Zhao, zhao-yuying@163.com
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