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

Sponsor
Hai Tian (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT06047249
Collaborator
(none)
200
1
4
22.5
8.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: KAP Popular Science Research
  • Behavioral: No KAP Popular Science Research
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Single (Care Provider)
Primary Purpose:
Treatment
Official Title:
Study on the Mechanism of Prevotella Copri Promoting the Occurrence and Development of Atherosclerosis
Actual Study Start Date :
Aug 23, 2022
Anticipated Primary Completion Date :
Jul 7, 2024
Anticipated Study Completion Date :
Jul 7, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Concentration of Brain Natriuretic Peptide [Within 7 days after surgery]

    Blood sampling and testing

  2. Concentration of myocardial enzyme [Within 7 days after surgery]

    Blood sampling and testing

  3. Concentration of troponin [Within 7 days after surgery]

    Blood sampling and testing

  4. questionnaire1 [Within 7 days after admission]

    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

  5. questionnaire2 [Within 7 days after surgery]

    Composed of 5 questions, choose the expected answer and add 1 point. The higher the score, the better

  6. Prevotella copri abundance [through study completion, an average of 1 year]

    16S ribosomal DNA identification sequencing of feces

  7. Concentration of branched chain amino acids [through study completion, an average of 1 year]

    Blood sampling and testing

  8. Concentration of serotonin [through study completion, an average of 1 year]

    Blood sampling and testing

  9. lipopolysaccharides [through study completion, an average of 1 year]

    Blood sampling and testing

  10. Concentration of blood glucose [through study completion, an average of 1 year]

    Blood sampling and testing

  11. Concentration of lipids [through study completion, an average of 1 year]

    Blood sampling and testing

  12. cardiac ejection fraction [Within 7 days after surgery]

    Ultrasonic instrument exploration

  13. cardiac ejection fraction [7 days before surgery]

    Ultrasonic instrument exploration

  14. ejection volume [7 days before surgery]

    Ultrasonic instrument exploration

  15. ejection volume [Within 7 days after surgery]

    Ultrasonic instrument exploration

  16. left ventricular size [Within 7 days after surgery]

    Ultrasonic instrument exploration

  17. left ventricular size [7 days before surgery]

    Ultrasonic instrument exploration

  18. end diastolic diameter [7 days before surgery]

    Ultrasonic instrument exploration

  19. end diastolic diameter [Within 7 days after surgery]

    Ultrasonic instrument exploration

  20. left ventricular end systolic diameter [Within 7 days after surgery]

    Ultrasonic instrument exploration

  21. left ventricular end systolic diameter [7 days before surgery]

    Ultrasonic instrument exploration

  22. pulmonary artery pressure [7 days before surgery]

    Ultrasonic instrument exploration

  23. pulmonary artery pressure [Within 7 days after surgery]

    Ultrasonic instrument exploration

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Second Affiliated Hospital of Harbin Medical University Harbin Heilongjiang China 150086

Sponsors and Collaborators

  • Hai Tian

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hai Tian, Clinical Professor, The Second Affiliated Hospital of Harbin Medical University
ClinicalTrials.gov Identifier:
NCT06047249
Other Study ID Numbers:
  • 2ndHarbinMU2022
First Posted:
Sep 21, 2023
Last Update Posted:
Sep 21, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 21, 2023