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

Atherosclerosis Clinical Trial

— SOMOFPcopri  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06047249
• Other study ID #: 2ndHarbinMU2022
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 23, 2022
• Est. completion date: July 7, 2024

Study information

• Verified date: September 2023
• Source: The Second Affiliated Hospital of Harbin Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: July 7, 2024
• Est. primary completion date: July 7, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

Behavioral:
• KAP Popular Science Research
By conducting a survey questionnaire, investigate the knowledge, attitude, and practice tendencies of patients and their caregivers towards a certain disease, and conduct relevant science popularization;Pre discharge satisfaction survey questionnaire
• No KAP Popular Science Research
Pre discharge satisfaction survey questionnaire

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
Hai Tian

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of Brain Natriuretic Peptide	Blood sampling and testing	Within 7 days after surgery
Primary	Concentration of myocardial enzyme	Blood sampling and testing	Within 7 days after surgery
Primary	Concentration of troponin	Blood sampling and testing	Within 7 days after surgery
Primary	questionnaire1	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	Within 7 days after admission
Primary	questionnaire2	Composed of 5 questions, choose the expected answer and add 1 point. The higher the score, the better	Within 7 days after surgery
Primary	Prevotella copri abundance	16S ribosomal DNA identification sequencing of feces	through study completion, an average of 1 year
Primary	Concentration of branched chain amino acids	Blood sampling and testing	through study completion, an average of 1 year
Primary	Concentration of serotonin	Blood sampling and testing	through study completion, an average of 1 year
Primary	lipopolysaccharides	Blood sampling and testing	through study completion, an average of 1 year
Primary	Concentration of blood glucose	Blood sampling and testing	through study completion, an average of 1 year
Primary	Concentration of lipids	Blood sampling and testing	through study completion, an average of 1 year
Primary	cardiac ejection fraction	Ultrasonic instrument exploration	Within 7 days after surgery
Primary	cardiac ejection fraction	Ultrasonic instrument exploration	7 days before surgery
Primary	ejection volume	Ultrasonic instrument exploration	7 days before surgery
Primary	ejection volume	Ultrasonic instrument exploration	Within 7 days after surgery
Primary	left ventricular size	Ultrasonic instrument exploration	Within 7 days after surgery
Primary	left ventricular size	Ultrasonic instrument exploration	7 days before surgery
Primary	end diastolic diameter	Ultrasonic instrument exploration	7 days before surgery
Primary	end diastolic diameter	Ultrasonic instrument exploration	Within 7 days after surgery
Primary	left ventricular end systolic diameter	Ultrasonic instrument exploration	Within 7 days after surgery
Primary	left ventricular end systolic diameter	Ultrasonic instrument exploration	7 days before surgery
Primary	pulmonary artery pressure	Ultrasonic instrument exploration	7 days before surgery
Primary	pulmonary artery pressure	Ultrasonic instrument exploration	Within 7 days after surgery