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临床试验/NCT06047249
NCT06047249Enrolling By Invitation不适用

Study on the Mechanism of Prevotella Copri Promoting the Occurrence and Development of Atherosclerosis

Hai Tian1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年8月23日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
200
试验地点
1
主要终点
Concentration of Brain Natriuretic Peptide

研究概览

简要总结

Mainly studying the correlation between the abundance of Prevotella copri (P.copri) in the gut microbiome and the progression of clinical coronary atherosclerotic heart disease(CAD) patients, and confirming that an increase in P.copri abundance will accelerate the occurrence and development of CAD disease, accompanied by an increase in serum Branched chain amino acid(BCAA), lipopolysaccharide(LPS), and serotonin; For people who mainly consume a high carbon water diet, blood sugar is a stronger risk factor for AS compared to blood lipids; Explore the KAP status(Study composes of Knowledge, attitude, and practice) of coronary heart disease patients and their caregivers regarding coronary heart disease and diet, and investigate whether the popularization of science after KAP investigation can change the treatment effect of patients.

详细描述

Confirming the progression of coronary heart disease in patients and the proportion of P.copri in the gut microbiome; Confirming that due to the increased abundance of P.copri, factors related to blood glucose metabolism disorders are more associated with the progression of CAD disease compared to lipid factors; Confirming that P.copri induces insulin resistance and inflammation in the body while altering intestinal permeability through the synthesis of BCAA, LPS, and serotonin;; Through controlled experiments conducted at our center, investigators effectively popularized disease science to patients and their caregivers, promoted their participation in disease treatment, and confirmed that the KAP survey method can optimize patient treatment effectiveness, improve doctor-patient relationships, and enhance patient hospitalization experience. Through this research project, investigators explore the application of KAP research in the form of a questionnaire in this discipline. Through KAP research, investigators aim to popularize knowledge about dietary patterns and coronary heart disease among multi center coronary heart disease patients and their caregivers. investigators also investigate the "knowledge", "belief", and "behavior" of current coronary heart disease patients and their caregivers regarding coronary heart disease diagnosis and treatment knowledge, and conduct a knowledge lecture, Establish a new model for mastering, attitudes, and actions related to the diagnosis and treatment of coronary heart disease among patients and their accompanying caregivers through data push and other forms, while also providing theoretical and practical basis for subsequent related research. Through this project, investigators will discuss the feasibility of KAP survey in increasing patients' subjective initiative, improving doctor-patient relationships, and promoting the effectiveness of patient treatment. investigators will also discuss its promotion and inclusion in routine diagnostic and treatment methods.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Single (Care Provider)

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Atherosclerosis mechanism research: diagnosis is made through clinical diagnostic technical indicators, mainly coronary CT or coronary angiography. Experimental group: patients with coronary heart disease are identified; Control group: Admitted patients without coronary heart disease but may have other heart diseases or risk factors; Age:>50 years old
  • KAP Study: Coronary Heart Disease Patients and Their Families

排除标准

  • Atherosclerosis mechanism research: age<50 years old; Patients with a history of coronary heart disease or surgery; Patients with systemic diseases, including liver and kidney diseases (with serum creatinine levels>2mg/dL (176.8 μ Mol/dL), collagen diseases, etc; Patients who have been using antibiotics within the past 6 months; Patients with malignant tumor disease
  • KAP Study: Non coronary heart disease patients and their caregivers

结局指标

主要结局

Concentration of Brain Natriuretic Peptide

时间窗: Within 7 days after surgery

Blood sampling and testing

Concentration of myocardial enzyme

时间窗: Within 7 days after surgery

Blood sampling and testing

left ventricular end systolic diameter

时间窗: 7 days before surgery

Ultrasonic instrument exploration

pulmonary artery pressure

时间窗: Within 7 days after surgery

Ultrasonic instrument exploration

Concentration of troponin

时间窗: Within 7 days after surgery

Blood sampling and testing

questionnaire1

时间窗: Within 7 days after admission

KAP scale,This questionnaire consists of a total of 25 questions, with the first 7 questions being the baseline survey of the subjects, which facilitates statistical information without involving scores. The remaining questions consist of 10 knowledge questions (each desired response was scored 1, maximum K-score was 10), 5 attitude questions (each desired response was scored 1, maximum A-score was 5), and 3 practice questions (this question consists of 5 options, depending on frequency or severity, 1 is obtained when selecting 1 or 2 options, 2 is obtained when selecting 3 options, 3 is obtained when selecting 4 or 5 options, and 5 is obtained when selecting maximum P-score was 5),higher scores mean a better outcome

questionnaire2

时间窗: Within 7 days after surgery

Composed of 5 questions, choose the expected answer and add 1 point. The higher the score, the better

Prevotella copri abundance

时间窗: through study completion, an average of 1 year

16S ribosomal DNA identification sequencing of feces

left ventricular size

时间窗: 7 days before surgery

Ultrasonic instrument exploration

Concentration of branched chain amino acids

时间窗: through study completion, an average of 1 year

Blood sampling and testing

Concentration of serotonin

时间窗: through study completion, an average of 1 year

Blood sampling and testing

lipopolysaccharides

时间窗: through study completion, an average of 1 year

Blood sampling and testing

Concentration of blood glucose

时间窗: through study completion, an average of 1 year

Blood sampling and testing

Concentration of lipids

时间窗: through study completion, an average of 1 year

Blood sampling and testing

cardiac ejection fraction

时间窗: 7 days before surgery

Ultrasonic instrument exploration

ejection volume

时间窗: Within 7 days after surgery

Ultrasonic instrument exploration

end diastolic diameter

时间窗: Within 7 days after surgery

Ultrasonic instrument exploration

次要结局

未报告次要终点

研究者

发起方
Hai Tian
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hai Tian

Clinical Professor

The Second Affiliated Hospital of Harbin Medical University

研究点 (1)

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