Metabolomics Characterization of Biomarkers of ASCVD and Prediction Model

NCT ID: NCT05148182

Last Updated: 2021-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1869 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-15

Study Completion Date

2024-12-15

Brief Summary

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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

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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.

Conditions

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Atherosclerosis Prediction Model

Keywords

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metabolomics Atherosclerosis Biomarkers prediction model

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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low risk

According to the China PAR equations and Chinese guidelines and consensus on cardiovascular risk assessment and management, it is considered as low-risk population.

No interventions assigned to this group

medium risk

According to the China PAR equations and Chinese guidelines and consensus on cardiovascular risk assessment and management, it is considered as medium-risk population.

No interventions assigned to this group

high risk

According to the China PAR equations and Chinese guidelines and consensus on cardiovascular risk assessment and management, it is considered as high-risk population.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai 10th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ya-Wei Xu

Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Cardiology,Shanghai Tenth People's Hospital

Shanghai, , China

Site Status NOT_YET_RECRUITING

Shanghai Tenth People's Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Yan Cang, doctor

Role: primary

Yawei Xu, PhD

Role: backup

yan cang, doctor

Role: primary

Other Identifiers

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MEAL

Identifier Type: -

Identifier Source: org_study_id