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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

200

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Aug 2022

Typical duration for not_applicable

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.9 years study duration

Study Start

First participant enrolled

August 23, 2022

Completed

11 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2023

Completed

2 months until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2024

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2024

Completed

Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

1.9 years

First QC Date

July 17, 2023

Last Update Submit

September 19, 2023

Conditions

Atherosclerosis

Outcome Measures

Primary Outcomes (23)

Concentration of Brain Natriuretic Peptide
Blood sampling and testing
Within 7 days after surgery
Concentration of myocardial enzyme
Blood sampling and testing
Within 7 days after surgery
Concentration of troponin
Blood sampling and testing
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
Within 7 days after admission
questionnaire2
Composed of 5 questions, choose the expected answer and add 1 point. The higher the score, the better
Within 7 days after surgery
Prevotella copri abundance
16S ribosomal DNA identification sequencing of feces
through study completion, an average of 1 year
Concentration of branched chain amino acids
Blood sampling and testing
through study completion, an average of 1 year
Concentration of serotonin
Blood sampling and testing
through study completion, an average of 1 year
lipopolysaccharides
Blood sampling and testing
through study completion, an average of 1 year
Concentration of blood glucose
Blood sampling and testing
through study completion, an average of 1 year
Concentration of lipids
Blood sampling and testing
through study completion, an average of 1 year
cardiac ejection fraction
Ultrasonic instrument exploration
Within 7 days after surgery
cardiac ejection fraction
Ultrasonic instrument exploration
7 days before surgery
ejection volume
Ultrasonic instrument exploration
7 days before surgery
ejection volume
Ultrasonic instrument exploration
Within 7 days after surgery
left ventricular size
Ultrasonic instrument exploration
Within 7 days after surgery
left ventricular size
Ultrasonic instrument exploration
7 days before surgery
end diastolic diameter
Ultrasonic instrument exploration
7 days before surgery
end diastolic diameter
Ultrasonic instrument exploration
Within 7 days after surgery
left ventricular end systolic diameter
Ultrasonic instrument exploration
Within 7 days after surgery
left ventricular end systolic diameter
Ultrasonic instrument exploration
7 days before surgery
pulmonary artery pressure
Ultrasonic instrument exploration
7 days before surgery
pulmonary artery pressure
Ultrasonic instrument exploration
Within 7 days after surgery

Study Arms (4)

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

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

Behavioral: No KAP Popular Science Research

Interventions

KAP Popular Science ResearchBEHAVIORAL

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

KAP group

Pre discharge satisfaction survey questionnaire

Non KAP group

Eligibility Criteria

Age50 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Hai Tianlead

Study Sites (1)

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150086, China

Location

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

Hai Tian
Harbin Medical University Second Affiliated Hospital
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: CARE PROVIDER
Purpose: TREATMENT
Intervention Model: SEQUENTIAL
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Clinical Professor

Study Record Dates

First Submitted

July 17, 2023

First Posted

September 21, 2023

Study Start

August 23, 2022

Primary Completion

July 7, 2024

Study Completion

July 7, 2024

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing: Will not share

Locations

CN(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (23)

Study Arms (4)

Coronary heart disease group

Non coronary heart disease group

KAP group

Non KAP group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Data Sharing

Locations