Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06047249
Acronym
SOMOFPcopri
Enrollment
200
Registered
2023-09-21
Start date
2022-08-23
Completion date
2024-07-07
Last updated
2023-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis

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.

Interventions

BEHAVIORALKAP 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

BEHAVIORALNo KAP Popular Science Research

Pre discharge satisfaction survey questionnaire

Sponsors

Hai Tian
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
pulmonary artery pressure7 days before surgeryUltrasonic instrument exploration
Concentration of Brain Natriuretic PeptideWithin 7 days after surgeryBlood sampling and testing
Concentration of myocardial enzymeWithin 7 days after surgeryBlood sampling and testing
Concentration of troponinWithin 7 days after surgeryBlood sampling and testing
questionnaire1Within 7 days after admissionKAP 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
questionnaire2Within 7 days after surgeryComposed of 5 questions, choose the expected answer and add 1 point. The higher the score, the better
Prevotella copri abundancethrough study completion, an average of 1 year16S ribosomal DNA identification sequencing of feces
Concentration of branched chain amino acidsthrough study completion, an average of 1 yearBlood sampling and testing
Concentration of serotoninthrough study completion, an average of 1 yearBlood sampling and testing
lipopolysaccharidesthrough study completion, an average of 1 yearBlood sampling and testing
Concentration of blood glucosethrough study completion, an average of 1 yearBlood sampling and testing
Concentration of lipidsthrough study completion, an average of 1 yearBlood sampling and testing
cardiac ejection fractionWithin 7 days after surgeryUltrasonic instrument exploration
ejection volume7 days before surgeryUltrasonic instrument exploration
left ventricular sizeWithin 7 days after surgeryUltrasonic instrument exploration
end diastolic diameter7 days before surgeryUltrasonic instrument exploration
left ventricular end systolic diameterWithin 7 days after surgeryUltrasonic instrument exploration

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026