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

NCT ID: NCT06047249

Last Updated: 2023-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-23

Study Completion Date

2024-07-07

Brief Summary

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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

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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.

Conditions

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Atherosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

KAP Popular Science Research

Intervention Type BEHAVIORAL

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

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

Group Type SHAM_COMPARATOR

No KAP Popular Science Research

Intervention Type BEHAVIORAL

Pre discharge satisfaction survey questionnaire

Interventions

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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

Intervention Type BEHAVIORAL

No KAP Popular Science Research

Pre discharge satisfaction survey questionnaire

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hai Tian

OTHER

Sponsor Role lead

Responsible Party

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Hai Tian

Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Hai Tian

Role: PRINCIPAL_INVESTIGATOR

Harbin Medical University Second Affiliated Hospital

Locations

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The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Site Status

Countries

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China

Other Identifiers

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2ndHarbinMU2022

Identifier Type: -

Identifier Source: org_study_id

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