search
Back to results

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

Primary Purpose

Atherosclerosis

Status
Enrolling by invitation
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
KAP Popular Science Research
No KAP Popular Science Research
Sponsored by
Hai Tian
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atherosclerosis

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • The Second Affiliated Hospital of Harbin Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

No Intervention

Experimental

Sham Comparator

Arm Label

Coronary heart disease group

Non coronary heart disease group

KAP group

Non KAP group

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Concentration of Brain Natriuretic Peptide
Blood sampling and testing
Concentration of myocardial enzyme
Blood sampling and testing
Concentration of troponin
Blood sampling and testing
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
questionnaire2
Composed of 5 questions, choose the expected answer and add 1 point. The higher the score, the better
Prevotella copri abundance
16S ribosomal DNA identification sequencing of feces
Concentration of branched chain amino acids
Blood sampling and testing
Concentration of serotonin
Blood sampling and testing
lipopolysaccharides
Blood sampling and testing
Concentration of blood glucose
Blood sampling and testing
Concentration of lipids
Blood sampling and testing
cardiac ejection fraction
Ultrasonic instrument exploration
cardiac ejection fraction
Ultrasonic instrument exploration
ejection volume
Ultrasonic instrument exploration
ejection volume
Ultrasonic instrument exploration
left ventricular size
Ultrasonic instrument exploration
left ventricular size
Ultrasonic instrument exploration
end diastolic diameter
Ultrasonic instrument exploration
end diastolic diameter
Ultrasonic instrument exploration
left ventricular end systolic diameter
Ultrasonic instrument exploration
left ventricular end systolic diameter
Ultrasonic instrument exploration
pulmonary artery pressure
Ultrasonic instrument exploration
pulmonary artery pressure
Ultrasonic instrument exploration

Secondary Outcome Measures

Full Information

First Posted
July 17, 2023
Last Updated
September 19, 2023
Sponsor
Hai Tian
search

1. Study Identification

Unique Protocol Identification Number
NCT06047249
Brief Title
Study on the Mechanism of Prevotella Copri Promoting the Occurrence and Development of Atherosclerosis
Acronym
SOMOFPcopri
Official Title
Study on the Mechanism of Prevotella Copri Promoting the Occurrence and Development of Atherosclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 23, 2022 (Actual)
Primary Completion Date
July 7, 2024 (Anticipated)
Study Completion Date
July 7, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hai Tian

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Coronary heart disease group
Arm Type
No Intervention
Arm Description
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
Arm Title
Non coronary heart disease group
Arm Type
No Intervention
Arm Description
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
Arm Title
KAP group
Arm Type
Experimental
Arm Description
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
Arm Title
Non KAP group
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
KAP Popular Science Research
Intervention Description
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
Intervention Name(s)
No KAP Popular Science Research
Intervention Description
Pre discharge satisfaction survey questionnaire
Primary Outcome Measure Information:
Title
Concentration of Brain Natriuretic Peptide
Description
Blood sampling and testing
Time Frame
Within 7 days after surgery
Title
Concentration of myocardial enzyme
Description
Blood sampling and testing
Time Frame
Within 7 days after surgery
Title
Concentration of troponin
Description
Blood sampling and testing
Time Frame
Within 7 days after surgery
Title
questionnaire1
Description
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
Time Frame
Within 7 days after admission
Title
questionnaire2
Description
Composed of 5 questions, choose the expected answer and add 1 point. The higher the score, the better
Time Frame
Within 7 days after surgery
Title
Prevotella copri abundance
Description
16S ribosomal DNA identification sequencing of feces
Time Frame
through study completion, an average of 1 year
Title
Concentration of branched chain amino acids
Description
Blood sampling and testing
Time Frame
through study completion, an average of 1 year
Title
Concentration of serotonin
Description
Blood sampling and testing
Time Frame
through study completion, an average of 1 year
Title
lipopolysaccharides
Description
Blood sampling and testing
Time Frame
through study completion, an average of 1 year
Title
Concentration of blood glucose
Description
Blood sampling and testing
Time Frame
through study completion, an average of 1 year
Title
Concentration of lipids
Description
Blood sampling and testing
Time Frame
through study completion, an average of 1 year
Title
cardiac ejection fraction
Description
Ultrasonic instrument exploration
Time Frame
Within 7 days after surgery
Title
cardiac ejection fraction
Description
Ultrasonic instrument exploration
Time Frame
7 days before surgery
Title
ejection volume
Description
Ultrasonic instrument exploration
Time Frame
7 days before surgery
Title
ejection volume
Description
Ultrasonic instrument exploration
Time Frame
Within 7 days after surgery
Title
left ventricular size
Description
Ultrasonic instrument exploration
Time Frame
Within 7 days after surgery
Title
left ventricular size
Description
Ultrasonic instrument exploration
Time Frame
7 days before surgery
Title
end diastolic diameter
Description
Ultrasonic instrument exploration
Time Frame
7 days before surgery
Title
end diastolic diameter
Description
Ultrasonic instrument exploration
Time Frame
Within 7 days after surgery
Title
left ventricular end systolic diameter
Description
Ultrasonic instrument exploration
Time Frame
Within 7 days after surgery
Title
left ventricular end systolic diameter
Description
Ultrasonic instrument exploration
Time Frame
7 days before surgery
Title
pulmonary artery pressure
Description
Ultrasonic instrument exploration
Time Frame
7 days before surgery
Title
pulmonary artery pressure
Description
Ultrasonic instrument exploration
Time Frame
Within 7 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hai Tian
Organizational Affiliation
Harbin Medical University Second Affiliated Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Affiliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150086
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs