AtherosclerosisSOMOFPcopriNCT06047249
Study on the Mechanism of Prevotella Copri Promoting the Occurrence and Development of Atherosclerosis
A study testing KAP Popular Science Research and No KAP Popular Science Research in people with Atherosclerosis, run by Hai Tian at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- KAP Popular Science Research and No KAP Popular Science Research
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 23 Aug 2022to 7 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150086
About this study
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.
Read the 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.
- Conditions
- Atherosclerosis
- Being tested
- KAP Popular Science Research, No KAP Popular Science Research
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KAP Popular Science ResearchBehavioural
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
No KAP Popular Science ResearchBehavioural
Pre discharge satisfaction survey questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Coronary heart disease group | No intervention | 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 |
| Non coronary heart disease group | No intervention | 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 |
| KAP group | Experimental | 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 Receives: Behavioral: KAP Popular Science Research |
| Non KAP group | Sham comparator | 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 Receives: Behavioral: No KAP Popular Science Research |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Brain Natriuretic Peptide
Blood sampling and testing
Measured: Within 7 days after surgery
Concentration of myocardial enzyme
Blood sampling and testing
Measured: Within 7 days after surgery
Concentration of troponin
Blood sampling and testing
Measured: 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
Measured: Within 7 days after admission
questionnaire2
Composed of 5 questions, choose the expected answer and add 1 point. The higher the score, the better
Measured: Within 7 days after surgery
Prevotella copri abundance
16S ribosomal DNA identification sequencing of feces
Measured: through study completion, an average of 1 year
Concentration of branched chain amino acids
Blood sampling and testing
Measured: through study completion, an average of 1 year
Concentration of serotonin
Blood sampling and testing
Measured: through study completion, an average of 1 year
lipopolysaccharides
Blood sampling and testing
Measured: through study completion, an average of 1 year
Concentration of blood glucose
Blood sampling and testing
Measured: through study completion, an average of 1 year
Concentration of lipids
Blood sampling and testing
Measured: through study completion, an average of 1 year
cardiac ejection fraction
Ultrasonic instrument exploration
Measured: Within 7 days after surgery
cardiac ejection fraction
Ultrasonic instrument exploration
Measured: 7 days before surgery
ejection volume
Ultrasonic instrument exploration
Measured: 7 days before surgery
ejection volume
Ultrasonic instrument exploration
Measured: Within 7 days after surgery
left ventricular size
Ultrasonic instrument exploration
Measured: Within 7 days after surgery
left ventricular size
Ultrasonic instrument exploration
Measured: 7 days before surgery
end diastolic diameter
Ultrasonic instrument exploration
Measured: 7 days before surgery
end diastolic diameter
Ultrasonic instrument exploration
Measured: Within 7 days after surgery
left ventricular end systolic diameter
Ultrasonic instrument exploration
Measured: Within 7 days after surgery
left ventricular end systolic diameter
Ultrasonic instrument exploration
Measured: 7 days before surgery
pulmonary artery pressure
Ultrasonic instrument exploration
Measured: 7 days before surgery
pulmonary artery pressure
Ultrasonic instrument exploration
Measured: Within 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start23 Aug 2022
- Primary completion7 Jul 2024 (estimated)
- Study completion7 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hai Tian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hai Tian, The Second Affiliated Hospital of Harbin Medical University
- Investigators
- Hai Tian, Principal investigator, Harbin Medical University Second Affiliated Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047249
- Sponsor's protocol ID
- 2ndHarbinMU2022
- Acronym
- SOMOFPcopri
- Status last verified
- Sep 2023
- First submitted
- 17 Jul 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Mechanism of Prevotella Copri Promoting the Occurrence and Development of Atherosclerosis
- ClinicalTrials.gov ID
- NCT06047249
- Acronym / sponsor ID
- SOMOFPcopri / 2ndHarbinMU2022
- Conditions
- Atherosclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hai TianUniversity, hospital or other
- Study start
- 23 Aug 2022 (actual)
- Primary completion
- 7 Jul 2024 (estimated)
- Study completion
- 7 Jul 2024 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Coronary heart disease group | No intervention | –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 |
| Non coronary heart disease group | No intervention | –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 |
| KAP group | Experimental | Behavioral: KAP Popular Science ResearchConduct 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 |
| Non KAP group | Sham comparator | Behavioral: No KAP Popular Science ResearchInvestigators 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 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KAP Popular Science ResearchBy 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 | Behavioural | KAP group |
| No KAP Popular Science ResearchPre discharge satisfaction survey questionnaire | Behavioural | Non KAP group |
Primary outcome
Concentration of Brain Natriuretic Peptide
Time frame: Within 7 days after surgery
Blood sampling and testing
Concentration of myocardial enzyme
Time frame: Within 7 days after surgery
Blood sampling and testing
Concentration of troponin
Time frame: Within 7 days after surgery
Blood sampling and testing
questionnaire1
Time frame: 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
questionnaire2
Time frame: Within 7 days after surgery
Composed of 5 questions, choose the expected answer and add 1 point. The higher the score, the better
Prevotella copri abundance
Time frame: through study completion, an average of 1 year
16S ribosomal DNA identification sequencing of feces
Concentration of branched chain amino acids
Time frame: through study completion, an average of 1 year
Blood sampling and testing
Concentration of serotonin
Time frame: through study completion, an average of 1 year
Blood sampling and testing
lipopolysaccharides
Time frame: through study completion, an average of 1 year
Blood sampling and testing
Concentration of blood glucose
Time frame: through study completion, an average of 1 year
Blood sampling and testing
Concentration of lipids
Time frame: through study completion, an average of 1 year
Blood sampling and testing
cardiac ejection fraction
Time frame: Within 7 days after surgery
Ultrasonic instrument exploration
cardiac ejection fraction
Time frame: 7 days before surgery
Ultrasonic instrument exploration
ejection volume
Time frame: 7 days before surgery
Ultrasonic instrument exploration
ejection volume
Time frame: Within 7 days after surgery
Ultrasonic instrument exploration
left ventricular size
Time frame: Within 7 days after surgery
Ultrasonic instrument exploration
left ventricular size
Time frame: 7 days before surgery
Ultrasonic instrument exploration
end diastolic diameter
Time frame: 7 days before surgery
Ultrasonic instrument exploration
end diastolic diameter
Time frame: Within 7 days after surgery
Ultrasonic instrument exploration
left ventricular end systolic diameter
Time frame: Within 7 days after surgery
Ultrasonic instrument exploration
left ventricular end systolic diameter
Time frame: 7 days before surgery
Ultrasonic instrument exploration
pulmonary artery pressure
Time frame: 7 days before surgery
Ultrasonic instrument exploration
pulmonary artery pressure
Time frame: Within 7 days after surgery
Ultrasonic instrument exploration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hai Tian principal investigator
Harbin Medical University Second Affiliated Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KAP Popular Science Research and No KAP Popular Science Research in people with Atherosclerosis, run by Hai Tian at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of Brain Natriuretic Peptide (time frame: Within 7 days after surgery). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.