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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Atherosclerosis
• Intervention / Treatment: Behavioral: KAP Popular Science Research; Behavioral: No KAP Popular Science Research

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150086
      • The Second Affiliated Hospital of Harbin Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Coronary heart disease group; 16SrDNA sequencing and ELISA test were carried out for patients over 50 years old who reported coronary atherosclerosis after coronary angiography or coronary angiography with CT examination to detect the abundance of Prevotella in their intestines, the concentration of 5-hydroxytryptamine, branched chain amino acids and lipopolysaccharide in their blood
No Intervention: Non coronary heart disease group; For patients over 50 years old who reported no coronary atherosclerosis after coronary angiography or CTA examination, 16SrDNA sequencing and ELISA tests were carried out to detect the abundance of Prevotella in the intestinal tract, the concentration of 5-hydroxytryptamine, branched chain amino acids and lipopolysaccharide in the blood
Experimental: KAP group; Conduct a survey on the relationship between coronary heart disease and dietary patterns among hospitalized patients in the form of KAP Popular Science Research. After the survey, conduct scientific popularization of relevant knowledge, conduct a satisfaction questionnaire survey after surgery, and collect data on preoperative and postoperative examinations and laboratory tests	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
Sham Comparator: Non KAP group; Investigators will not conduct a survey on the relationship between coronary heart disease and dietary patterns among hospitalized patients, conduct science popularization, and conduct a satisfaction questionnaire survey after surgery	Behavioral: No KAP Popular Science Research; Pre discharge satisfaction survey questionnaire

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hai Tian
• Investigators: Principal Investigator: Hai Tian, Harbin Medical University Second Affiliated Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2022
• Primary Completion (Estimated): July 7, 2024
• Study Completion (Estimated): July 7, 2024

Study Registration Dates

• First Submitted: July 17, 2023
• First Submitted That Met QC Criteria: September 19, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 19, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis
• Other Study ID Numbers: 2ndHarbinMU2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No