Abstract
BackgroundWith the increased understanding of heart disease, microvascular angina (MVA) is receiving greater attention from clinicians. Studies have shown that patients with MVA have significantly higher major cardiovascular events and all-cause mortality than the control population, and the search for effective treatments is of great clinical importance. Both basic and clinical studies have shown that Qi-Jing Hui-Xin Decoction (QJHX) can relieve angina symptoms and improve clinical efficacy, but there is a lack of high-quality clinical studies to provide a research basis. This article introduces the evaluation protocol of QJHX for the adjunctive treatment of MVA.Methods/designThis is a prospective randomized controlled trial. The trial will enroll 150 patients with MVA. On the basis of Western drug treatment, patients will be randomized into two groups, and the experimental group will receive QJHX treatment for 12 weeks and follow-up at 24 week. The primary indicators are the clinical efficacy of angina pectoris and the evidence of traditional Chinese medicine (TCM) efficacy. Secondary indicators are the Seattle Angina Scale score, serum lipid levels, electrocardiogram, and echocardiogram diagnosis. Additional indicators are endothelial function and immunoinflammatory factors. Adverse events will be monitored throughout the trial.DiscussionIntegrated traditional Chinese and Western medicine is commonly used for angina in China. This study will evaluate the clinical effectiveness and safety of adding QJHX based on standardized Western medications. The results of the trial will provide high-level clinical research-based evidence for the application of QJHX in MVA.Trial registrationChinese Clinical Trial Registry ChiCTR1900027015. Registered on 28 October 2019.
Highlights
Microvascular angina (MVA) is a clinical syndrome manifested by exertional angina or myocardial ischemia caused by dysfunction of small anterior coronary arteries and small arteries [2]
We propose to perform a multicenter randomized controlled clinical study to further observe the clinical efficacy of Qi-Jing Hui-Xin Decoction (QJHX) intervention in microvascular angina (MVA) patients and its effect on long-term prognosis
Statistical analysis will be performed using SPSS 22.0 software. This is the study protocol for an investigator-initiated preliminary clinical trial evaluating the effects of QJHX in patients with MVA
Summary
This is the study protocol for an investigator-initiated preliminary clinical trial evaluating the effects of QJHX in patients with MVA. Astragalus polysaccharide (APS), one of the main bioactive components of Astragalus, plays a protective role against cardiac vascular endothelial dysfunction in rats through anti-inflammation and improvement in the imbalance between reactive oxygen species and NO [20]. The results of this study will provide a basis for a large-scale randomized controlled study to further evaluate the efficacy and safety of QJHX in the treatment of primary microvascular angina pectoris, to preliminarily elucidate the mechanism of action, and to accumulate information for preclinical studies of new drugs.
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