Metabolomics Characterization of Biomarkers of ASCVD and Prediction Model

Recruiting

• Conditions: Atherosclerosis; Prediction Model

• Registration Number: NCT05148182
• Lead Sponsor: Shanghai 10th People's Hospital

Brief Summary

1. Describe the risk factors and metabonomics characteristics of atherosclerotic cardiovascular disease in Chinese patients.

2. Establish accurate prediction model of atherosclerotic heart disease.

Detailed Description

According to the Chinese cardiovascular disease report released in 2017, cardiovascular disease death is the leading cause of death of urban and rural residents, so cardiovascular disease risk assessment is particularly important. The development of cardiovascular risk assessment model was dated from Framingham Heart Study which first proposed the concept of risk factors, and then adjusted the model several times. In 2016, the China-PAR evaluated the cardiovascular disease risk of Chinese population. However, the application of metabolomics in coronary heart disease is a rapidly developing field and also a new field .

Therefore, the aim of this study was to

1.Describe the risk factors of atherosclerotic cardiovascular disease and the characteristics of metabolomics in Chinese population.

2. Establish an accurate prediction model of atherosclerotic heart disease. Research plan：

1. 1869 risk-stratified people were recruited.

2. Plasma samples were collected incluing disease status and other potential influencing factors.

3. Through the high-throughput detection of body metabolites, combined with multivariate statistical analysis, the metabolic markers with significant difference in different risk levels were screened for risk prediction.

4. All recruited people underwent coronary angiography.

5. The distribution of age and gender in each group should be matched and balanced as far as possible.

Study Timeline

• Study First Submitted: 2021-11-05
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-06
• Last Update Submitted: 2021-12-06
• Study First Posted: 2021-12-08
• Last Update Posted: 2021-12-08
• Study Start: 2021-12-15
• Primary Completion: 2024-12-15
• Study Completion: 2024-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1869

Inclusion Criteria

1. The age of the population is 18 or more than 18 years old.
2. According to China PAR equations, Chinese guidelines and consensus on cardiovascular risk assessment and management，it is considered as healthy, low, medium, high and extremely high risk group.
3. The subjects read and fully understood the patient's instructions and signed the informed consent

Exclusion Criteria

1. Refused to sign informed consent.
2. ACS is caused by surgery, trauma, or other diseases.
3. Age less than 18 years old.
4. Pregnant women.
5. In the past 3 months, the patients were treated with trauma surgery.
6. There are aortic dissection, pulmonary embolism, pneumonia, pericarditis, myocarditis, stress cardiomyopathy.
7. Severe heart failure.
8. Liver and kidney failure.
9. Blood borne infectious diseases: including HIV / AIDS, hepatitis B, hepatitis C, etc.
10. Patients with a history of malignancies, autoimmune diseases, severe infectious diseases and trauma.
11. Any condition (such as travel, speech disorder, mental disorder) that the researcher believes can significantly limit the completion of the patient's follow-up.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Coronary vascularization.	3 years	Coronary vascularization includes percutaneous coronary intervention, or/and percutaneous coronary artery dilatation, or/and percutaneous coronary artery bypass grafting.
All cause mortality	3 years	which refers to the total death caused by various causes in a certain period.
Metabolomics Characterization of Biomarkers	3 years	Metabonomics analysis uses a non targeted detection method to detect polar compounds and lipid compounds in blood. The characteristic peaks of substances that can be detected are detected by chromatography Series platform, and then these characteristic peaks are compared with the standard library containing more than 8000 metabolites to annotate the compounds and screen out the differential metabolites between groups.
Cardiac mortality	3 years	Cardiac death refers to the death caused by serious cardiac dysfunction or failure which caused by heart disease or injury in a certain period.

Trial Locations

Locations (2)

Department of Cardiology,Shanghai Tenth People's Hospital; 🇨🇳 Shanghai, China

Shanghai Tenth People's Hospital; 🇨🇳 Shanghai, China