Clinical trial NCT06047249: Study on the Mechanism of Prevotella Copri Promoting the Occurrence and Development of Atherosclerosis
Official title: Study on the Mechanism of Prevotella Copri Promoting the Occurrence and Development of Atherosclerosis
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Atherosclerosis
Lead sponsor: The Second Affiliated Hospital of Harbin Medical University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. 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
2. KAP Study: Coronary Heart Disease Patients and Their Families

Exclusion Criteria:

1. 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
2. KAP Study: Non coronary heart disease patients and their caregivers

Primary outcomes:
measure: Concentration of Brain Natriuretic Peptide
timeFrame: Within 7 days after surgery
measure: Concentration of myocardial enzyme
timeFrame: Within 7 days after surgery
measure: Concentration of troponin
timeFrame: Within 7 days after surgery
measure: questionnaire1
timeFrame: Within 7 days after admission
measure: questionnaire2
timeFrame: Within 7 days after surgery
measure: Prevotella copri abundance
timeFrame: through study completion, an average of 1 year
measure: Concentration of branched chain amino acids
timeFrame: through study completion, an average of 1 year
measure: Concentration of serotonin
timeFrame: through study completion, an average of 1 year
measure: lipopolysaccharides
timeFrame: through study completion, an average of 1 year
measure: Concentration of blood glucose
timeFrame: through study completion, an average of 1 year
measure: Concentration of lipids
timeFrame: through study completion, an average of 1 year
measure: cardiac ejection fraction
timeFrame: Within 7 days after surgery
measure: cardiac ejection fraction
timeFrame: 7 days before surgery
measure: ejection volume
timeFrame: 7 days before surgery
measure: ejection volume
timeFrame: Within 7 days after surgery
measure: left ventricular size
timeFrame: Within 7 days after surgery
measure: left ventricular size
timeFrame: 7 days before surgery
measure: end diastolic diameter
timeFrame: 7 days before surgery
measure: end diastolic diameter
timeFrame: Within 7 days after surgery
measure: left ventricular end systolic diameter
timeFrame: Within 7 days after surgery
measure: left ventricular end systolic diameter
timeFrame: 7 days before surgery
measure: pulmonary artery pressure
timeFrame: 7 days before surgery
measure: pulmonary artery pressure
timeFrame: Within 7 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Harbin
country: China
facility: The Second Affiliated Hospital of Harbin Medical University
state: Heilongjiang
Study officials:
affiliation: Harbin Medical University Second Affiliated Hospital
name: Hai Tian
role: PRINCIPAL_INVESTIGATOR
References: