Efficacy and Safety of Kuoxin Formula in the Treatment of Dilated Cardiomyopathy-Related Heart Failure: Study Protocol of a Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial.

Background: Dilated cardiomyopathy (DCM) is a severe heterogeneous cardiomyopathy characterized by cardiac enlargement and declining heart function, often leading to refractory heart failure and life-threatening outcomes, particularly prevalent in China. The challenge lies in the scarcity of targeted therapies with substantial efficacy for DCM. Additionally, traditional anti-heart failure drugs are constrained due to hypotension propensity or limited symptom improvement. Kuoxin Formula (KXF), internally endorsed at Longhua Hospital, demonstrates clear biological evidence for enhancing cardiac function and myocardial remodeling. Previous clinical studies suggest its potential to enhance patients' quality of life. This trial aims to further evaluate KXF's safety and efficacy in managing DCM-related heart failure. Methods: This prospective, randomized, double-blind, placebo-controlled, multicenter trial aims to recruit 230 DCM patients from five centers. Participants will be randomly assigned to either KXF or placebo for 12 weeks, with careful monitoring of key indicators and adverse events. The primary outcome measures the proportion of patients with NT-proBNP reduction exceeding 30%. Secondary outcomes include New York Heart Association functional classification, Traditional Chinese Medicine syndrome scores, 6-minute walk test, Lee's heart failure score, and Minnesota Heart Failure Quality of Life Scale score. Ventricular remodeling will be assessed using cardiac ultrasound and ELISA. Safety metrics and adverse events will be meticulously recorded. Discussion: This study will be the first multicentered research conducted in China that utilizes a randomized, double-blind, placebo-controlled design to investigate the use of TCM in the treatment of DCM. It seeks to develop new theoretical frameworks and provide solid clinical data to support the integration of TCM and modern medicine in treating heart failure in DCM patients. Trial Registration: China Clinical Trial Registry, ChiCTR2300068937. Registered on March 1, 2023. https://www.chictr.org.cn/bin/project/edit?pid=190926.

Cinnamaldehyde alleviates doxorubicin-induced cardiotoxicity by decreasing oxidative stress and ferroptosis in cardiomyocytes.

Although doxorubicin (DOX) is an efficient chemotherapeutic drug for human tumors, severe cardiotoxicity restricts its clinical use. Cinnamaldehyde (CA), a bioactive component isolated from Cinnamonum cassia, possesses potent anti-oxidative and anti-apoptotic potentials. The major aim of this study was to evaluate the protective role of CA against DOX-induced cardiotoxicity. To this end, cardiomyocyte injury models were developed using DOX-treated H9c2 cells and DOX-treated rats, respectively. Herein, we found that CA treatment increased cardiomyocyte viability and attenuated DOX-induced cardiomyocyte death in vitro. CA further protected rats against DOX-induced cardiotoxicity, as indicated by elevated creatine kinase (CK) and lactate dehydrogenase (LDH) levels, myocardium injury, and myocardial fibrosis. CA alleviated DOX-induced myocardial oxidative stress by regulating reactive oxygen species (ROS), malondialdehyde (MDA), superoxide dismutase (SOD), and glutathione (GSH) levels. Mechanistically, CA markedly accelerated nuclear translocation of nuclear erythroid factor 2-related factor 2 (Nrf2) and increased heme oxygenase-1 (HO-1) expression. Consequently, CA decreased DOX-induced cardiomyocyte ferroptosis, while Erastin (a ferroptosis agonist) treatment destroyed the effect of CA on increasing cardiomyocyte viability. Taken together, the current results demonstrate that CA alleviates DOX-induced cardiotoxicity, providing a promising opportunity to increase the clinical application of DOX.

Adaptive VMD-K-SVD-Based Rolling Bearing Fault Signal Enhancement Study.

To address the challenges associated with nonlinearity, non-stationarity, susceptibility to redundant noise interference, and the difficulty in extracting fault feature signals from rolling bearing signals, this study introduces a novel combined approach. The proposed method utilizes the variational mode decomposition (VMD) and K-singular value decomposition (K-SVD) algorithms to effectively denoise and enhance the collected rolling bearing signals. Initially, the VMD method is employed to separate the overall noise into intrinsic mode functions (IMFs), reducing the noise content within each IMF. To optimize the mode component, K, and the penalty factor, α, in VMD, an improved arithmetic optimization algorithm (IAOA) is employed. This ensures the selection of optimal parameters and the decomposition of the signal into a set of IMFs, forming the original dictionary. Subsequently, the signals are decomposed into multiple IMFs using VMD, and an original dictionary is constructed based on these IMFs. K-SVD is then applied to the original dictionary to further reduce the noise in each IMF, resulting in a denoised and enhanced signal. To validate the efficacy of the proposed method, rolling bearing signals collected from Case Western Reserve University (CWRU) and thrust bearing test rigs were utilized. The experimental results demonstrate the feasibility and effectiveness of the proposed approach in denoising and enhancing the rolling bearing signals.

Acute myocardial infarction due to coronary embolism caused by a metastatic mass from lung cancer.

BACKGROUND: Acute arterial embolism due to tumor embolus is a rare complication in cancer patients, even rarer is lung tumor embolization leading to acute myocardial infarction. We report a patient who had a diagnosis of acute myocardial infarction(AMI)which was brought on by a coronary artery embolism by a metastatic lung cancer tumor. Clinicians need to be aware that tumor embolism can result in AMI. CASE PRESENTATION: An 80-yeal-old male patient presented with persistent chest pain for 2 h and his electrocardiogram(ECG)showed anterior ST-segment elevation myocardial infarction. Instead of implanting a stent, thrombus aspiration was performed. Pathological examination of coronary artery thrombosis showed that a few sporadic atypical epithelial cells were scattered in the thrombus-like tissue. Combined with immune phenotype and clinical history, metastatic squamous cell carcinoma is more likely. CONCLUSIONS: We report a rare case of a patient who was diagnosed of AMI due to a coronary artery embolism by a metastatic mass from lung cancer. Since there is no evidence-based protocol available for the treatment of isolated coronary thrombosis, we used thrombus aspiration to treat thrombosis rather than implanting a stent.

Experimental Study on Chemical-Mechanical Synergistic Preparation for Cemented Carbide Insert Cutting Edge.

Typical edge defects in the edge region of a new cemented carbide insert without edge preparation include burrs, poor surface quality, micro-breakages, and irregularities along the edge. To address the problems in new cemented carbide inserts without edge preparations, a chemical-mechanical synergistic preparation (CMSP) method for the cemented carbide insert cutting edge was proposed. Firstly, the CMSP device for the insert cutting edge was constructed. Then, the polishing slurry of the CMSP for the insert cutting edge was optimized using the Taguchi method combined with a grey relation analysis and fuzzy inference. Finally, orthogonal experiments, the Taguchi method, and analysis of variance (ANOVA) were used to investigate the effect of the polishing plate's rotational speed, swing angle, and input frequency of the controller on the edge preparation process, and the parameters were optimized. The results showed that the best parameter combination for the polishing slurry for the cemented carbide inserts was the mass concentration of the abrasive particle of 10 wt%, the mass concentration of the oxidant of 10 wt%, the mass concentration of the dispersant of 2 wt%, and the pH of 8. The CMSP process parameter combination for the linear edge had the polishing plate's rotational speed of 90 rpm, the swing angle of 6°, and the input frequency of the controller of 5000 Hz. The optimum CMSP process parameter combination for the circular edge had the polishing plate's rotational speed of 90 rpm, the swing angle of 6°, and the input frequency of the controller of 7000 Hz. The polishing plate's rotational speed had the most significant impact on the edge preparation process, followed by the swing angle, and the effect of the input frequency of the controller was the smallest. This study demonstrated that CMSP is a potential way to treat the cemented carbide insert cutting edge in a tool enterprise.

Huatan Dingji Decoction intervening in atrial fibrillation: protocol for a randomized double-blind single-simulated placebo-controlled clinical trial.

BACKGROUND: Atrial fibrillation (AF) is one of the most common cardiac arrhythmias and can lead to heart failure (HF), stroke, pulmonary embolism (PE), and other complications, seriously affecting people's quality of life and health. Western medicine is limited in the treatment of AF, while Traditional Chinese Medicine (TCM) has unique advantages, such as less side effects, low toxicity, long effect duration, and high compliance. The prescription of HTDJ is a common prescription for the treatment of atrial fibrillation in Longhua Hospital, Shanghai University of Traditional Chinese Medicine. It has been used for many years and has a large number of clinically effective cases. It has a good clinical application prospect, but there is a lack of effective evaluation of its clinical efficacy. METHOD: This study adopts a randomized double-blind, single-simulated, placebo-controlled research method. Participants were randomly assigned in a 1:1 ratio through a centrally controlled, computer-generated, simple randomization schedule. Participants would take the medicine for 1 month, and the curative effect would be evaluated. Subsequently, the participants would not take TCM and only receive western medicine treatment. They would be followed up for another 8 weeks, and a clinical evaluation would be conducted. The secondary outcomes include echocardiography, Hamilton Anxiety Scale, Hamilton Depression Scale, rate of increase and decrease of anti-arrhythmia western medicine, the MOS 36-item short-form health survey, N-terminal-pro hormone B-type natriuretic peptide level, and integral TCM syndrome score. Adverse events will be monitored throughout the trial. Cases are from outpatient and inpatient with atrial fibrillation in the Cardiology Department of Longhua Hospital. Evaluations will be conducted at baseline and at weeks 4 and 12 after randomization. DISCUSSION: In this study, the efficacy and safety of HTDJ plus western medicine in the treatment of atrial fibrillation (qi deficiency and phlegm opacities) will be evaluated, so as to provide medical evidence of short-term and medium-term clinical efficacy for the treatment of atrial fibrillation with integrated traditional and western medicine and lay a foundation for further clinical development and application. TRIAL REGISTRATION: ClinicalTrials.gov ChiCTR2000030517 . Registered on March 5, 2020, with the Chinese Clinical Trial Registry.

A double-blinded, placebo-controlled randomized trial evaluating the efficacy and safety of Zhigancao Tang granules for treating HFpEF: study protocol for a randomized controlled trial.

BACKGROUND: Heart failure with preserved ejection fraction (HFpEF) is a clinical syndrome characterized by diastolic dysfunction. Despite the increasing incidence of HFpEF, there is no available therapy that reduces the mortality rate of HFpEF. Zhigancao Tang has been used traditionally for the treatment of cardiovascular diseases in China. The use of traditional Chinese medicine (TCM) is associated with improvements in clinical syndromes and quality of life of patients. A randomized clinical trial should be conducted to provide clear evidence regarding the efficacy and safety of Zhigancao Tang granules for the treatment of HFpEF. METHODS: A randomized, double-blinded, placebo-controlled clinical trial was proposed. A total of 122 patients with HFpEF will be randomly assigned to receive Zhigancao Tang granules or placebo for 12 weeks. The primary outcome measure is cardiac function. The secondary outcomes include measurement of the integral TCM syndrome score, echocardiography, 6-min walk test, N-terminal-pro hormone B-type natriuretic peptide level, atrial natriuretic peptide level, Minnesota Living with Heart Failure scale, and Lee's scale. The outcome measures will be evaluated at baseline, 4 weeks, and 12 weeks. Adverse events will be evaluated from baseline till the 12-week follow-up period. DISCUSSION: The results of this trial will demonstrate whether Zhigancao Tang granules are effective and safe for treating HFpEF. TRIAL REGISTRATION: ClinicalTrials.gov NCT04317339 . Registered on 23 March 2020.

Vitamin D for inflammation biomarkers in coronary artery disease: A protocol for systematic review and meta-analysis.

BACKGROUND: Coronary artery disease (CAD) is a clinically common coronary heart disease. Vitamin D might be beneficial in CAD patients through its favorable effects on inflammation biomarkers. This study will be performed to examine the effects of Vitamin D supplementation on inflammatory markers in CAD patients. METHODS: We will search the electronical databases and hand-searching journals or reference lists. The study screening and data extraction will be carried out by 2 investigators independently. The primary outcome is inflammatory biomarkers of peripheral blood. Secondary outcomes are triglyceride, total cholesterol, high-density lipoprotein cholesterol levels, low-density lipoprotein cholesterol, and blood pressure. Review Manager (RevMan, version 5.3; The Nordic Cochrane Centre, Copenhagen, Denmark: http://community.cochrane.org) V.5.3 software will be used to compute the data. RESULTS: The results of the study will provide a reliable evidence to assess the efficacy of Vitamin D supplement on inflammation biomarkers of CAD patients. CONCLUSION: The conclusion of our systematic review will answer whether Vitamin D is an effective intervention to relieve inflammation of CAD patients. ETHICS: Because all of the data used in this review has been published, this review does not require ethical approval. REGISTRATION NUMBER: INPLASY202060072.

Music Intervention in Pain Relief of Cardiovascular Patients in Cardiac Procedures: A Systematic Review and Meta-analysis.

BACKGROUND: Numerous meta-analyses have been conducted on music and pain, but no studies have investigated music and cardiac procedural pain. OBJECTIVE: To assess the effects of music intervention on pain in cardiac procedures in the published randomized controlled trials. METHODS: This study was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. All the included randomized controlled studies were published between 1999 and 2016. Studies were obtained from electronic databases or by hand-searching of related journals and reference lists. The main outcome was pain intensity, and the secondary outcomes were vital signs such as heart rate, respiration rate, systolic blood pressure, and diastolic blood pressure. Risk of bias of the included studies was evaluated according to the Cochrane Collaboration guidelines. RESULTS: Analysis of 14 studies indicated that music interventions had statistically significant effects on decreasing pain scales (mean deviation [MD] = -1.84), heart rate (MD = -2.62), respiration rate (MD = -2.57), systolic blood pressure (MD = -5.11), and diastolic blood pressure (MD = 0.44). The subgroup analysis method was used in all five outcomes. CONCLUSIONS: Considering all the possible benefits, music intervention may provide an effective complement for the relief of cardiac procedural pain.

A multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of Taoren Honghua Jian granule in patients with stable coronary artery disease.

INTRODUCTION: Stable coronary artery disease (SCAD) is a common clinical style in patients with coronary artery disease. Inflammation and immune injury in SCAD have been proven. Current interventions can relieve patients' symptoms, but none are stable to improve the immune damage significantly. Chinese herb is used to treat stable angina pectoris as an alternative therapy. Taoren Honghua Jian granule (THJG) is a classical formula from which patients can benefit, but lack convincing evidence. Therefore, we report a protocol of high-quality randomized controlled trial. METHODS/DESIGN: We will conduct a randomized, double-blind, placebo-controlled clinical trial to assess the effect of THJG in relief of symptoms and blood immune indexes. A total of 80 patients with SCAD will be enrolled, and treated with THJG or placebo for 4 weeks. The primary outcome measurement is change of integral traditional Chinese medicine (TCM) syndrome score from baseline to 4 weeks' treatment. The 2nd outcome measurements include change of integral TCM syndrome scores from baseline to 2 weeks' treatment and another 4 weeks' follow-up, inflammation indexes at baseline and 4 weeks' treatment. It also includes Seattle Angina Questionnaire, major adverse cardiovascular events, Athens Insomnia scale, and 36-item short form health survey score from baseline to 2 weeks' and 4 weeks' treatment, and another 4 weeks' follow-up. Adverse events will be evaluated throughout the trial. DISCUSSION: The results of this trial will prove whether THJG could alleviate symptoms, control inflammation, and improve quality of life in patients with SCAD. TRIAL REGISTRATION: ChiCTR1900021772, registered 8 March, 2019.

[Effects of Chinese herbal medicine Guanxinkang on expression of PPARγ-LXRα-ABCA1 pathway in ApoE-knockout mice with atherosclerosis].

OBJECTIVE: To observe the effects of Guanxinkang (GXK) decoction, a compound traditional Chinese herbal medicine, on expressions of peroxisome proliferator-activated receptor γ (PPARγ), liver X receptor α (LXRα) and ATP-binding cassette transporter A1 (ABCA1) in apolipoprotein E (ApoE)-knockout mice with atherosclerosis. METHODS: Fourteen 6-week-old C57BL/6 J mice were used as normal control group. Seventy 6-week-old ApoE-knockout mice receiving a high-cholesterol diet to induce atherosclerosis were randomly divided into untreated group, simvastatin group and low-dose (concentration of crude drugs at 0.864 g/mL), medium-dose (crude drugs at 1.728 g/mL) and high-dose (crude drugs at 3.456 g/mL) GXK groups. After treated with the drugs for eight weeks continuously, the livers and aortas of mice were separated. The expressions of PPARγ, LXRα and ABCA1 were measured by real-time quantitative polymerase chain reaction and Western blotting respectively. RESULTS: Compared with the normal control group, mRNAs and proteins of PPARγ, LXRα and ABCA1 over-expressed in the untreated group (P<0.05). After the treatment, GXK decoction and simvastatin decreased the expressions of PPARγ, LXRα and ABCA1 (P<0.05). High-dose GXK decoction had more marked effects than low- and medium-dose GXK and simvastatin. CONCLUSION: The PPARγ-LXRα-ABCA1 pathway is involved in lipid regulation and inflammation activities. Over-expression of the genes has complicated effects on atherosclerosis in ApoE-knockout mice with high-cholesterol diet. GXK decoction has anti-inflammatory and anti-matrix metalloproteinase activities by regulating PPARγ, LXRα and ABCA1 interactions in the ApoE-knockout mice.

[Effects of Chinese herbal medicine Guanxinkang on lipid metabolism and serum C-reactive protein, amyloid A protein and fibrinogen in apolipoprotein E-knockout mice with atherosclerosis].

OBJECTIVE: To observe the effects of Guanxinkang (GXK) decoction, a compound traditional Chinese herbal medicine, on serum lipids and apolipoprotein A I (ApoA I), apolipoprotein B (ApoB), apolipoprotein E (ApoE), C-reactive protein (CRP), serum amyloid A protein (SAA) and fibrinogen (Fbg) concentrations of ApoE-knockout mice with atherosclerosis, and to explore the mechanism of GXK decoction in anti-atherosclerosis. METHODS: Seventy 6-week-old ApoE-knockout mice receiving a high-cholesterol diet were used to induce atherosclerosis and were randomly divided into 5 groups: untreated group, simvastatin group and low- (drug concentration is 0.864 g/mL), medium- (1.728 g/mL), and high-dose (3.456 g/mL) GXK groups. Another fourteen 6-week-old C57BL/6J mice were used as the normal control. Two 12-week-old mice were randomly selected from the normal control and the ApoE-knockout mice respectively to observe vulnerable plaque in the mouse's aortic by hematoxylin-eosin staining. Blood was collected from venous plexus of eye socket after gavage of corresponding drugs once daily for 8 weeks continuously, and then the serum was separated. Triglyceride (TAG) and total cholesterol (TC) were measured by enzyme-coupled assay; low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C) were measured by selective precipitation method. Serum levels of ApoA I and ApoB were determined by turbidimetry. Double-antibody sandwich enzyme-linked immunosorbent assay was used to detect ApoE, CRP, SAA and Fbg concentrations in serum. RESULTS: Compared with the normal control group, the levels of serum TC, TAG, LDL-C, ApoB, CRP, SAA and Fbg in the untreated group were increased (P<0.05), and the serum concentrations of HDL-C, ApoA I and ApoE in the untreated group were decreased (P<0.05). After treatment, GXK decoction and simvastatin improved the dyslipidemia by increasing the concentrations of ApoA I and HDL-C and decreasing the concentrations of TC, TAG, LDL-C, ApoB, CRP, SAA and Fbg (P<0.05). The high-dose GXK decoction had the most marked effects on SAA and Fbg and the serum lipids compared with the low-dose and medium-dose GXK and simvastatin. CONCLUSION: GXK decoction may not only provide an active effect on hyperlipidemia, but also down-regulate the levels of serum CRP, SAA and Fbg. GXK decoction exerts an anti-atherosclerosis effect in ApoE-knockout mice.