Metabolomics Characterization of Biomarkers of ASCVD and Prediction Model

NCT05148182 | Unknown DMC

• 1 other identifier: MEAL
• Study Type: observational
• Target: 1,869
• Locations: 1 country
• Sites: 2

Brief Summary

1. 1.Describe the risk factors and metabonomics characteristics of atherosclerotic cardiovascular disease in Chinese patients.
2. 2.Establish accurate prediction model of atherosclerotic heart disease.

Conditions

Atherosclerosis; Prediction Model

Keywords

metabolomics; Atherosclerosis; Biomarkers; prediction model

Outcome Measures

Primary Outcomes (4)

• Metabolomics Characterization of Biomarkers

  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.

  3 years

• Coronary vascularization.

  Coronary vascularization includes percutaneous coronary intervention, or/and percutaneous coronary artery dilatation, or/and percutaneous coronary artery bypass grafting.

  3 years

• All cause mortality

  which refers to the total death caused by various causes in a certain period.

  3 years

• Cardiac mortality

  Cardiac death refers to the death caused by serious cardiac dysfunction or failure which caused by heart disease or injury in a certain period.

  3 years

Study Arms (3)

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.

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.

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

According to China PAR equations and Chinese guidelines and consensus on cardiovascular risk assessment and management, the patients were defined as low, medium, high risk groups.

You may qualify if:

• The age of the population is 18 or more than 18 years old.
• 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.
• The subjects read and fully understood the patient's instructions and signed the informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (2)

Department of Cardiology,Shanghai Tenth People's Hospital

Shanghai, 200072, China

NOT YET RECRUITING

Shanghai Tenth People's Hospital

Shanghai, 200072, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

The instrument platforms of gas chromatography-mass spectrometry (GC-MS) and liquid chromatography-mass spectrometry (LC-MS) are used to metabonomic analysis. Small molecular metabolites in blood were measured by LC-MS and GC-MS.The instrument platforms of GC-MS and LC-MS are used. The samples tested on GC-MS platform need to be derivatized, mainly for the detection of polar and weak polar metabolites with molecular weight not higher than 1000Da and low boiling point; LC-MS uses different liquid phase systems to detect polar and weak polar metabolites, lipids and lipid soluble metabolites respectively; The same sample needs to be detected through five data acquisition modes on three mass spectrometry platforms.

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: December 8, 2021
• Study Start: December 15, 2021
• Primary Completion: December 15, 2024
• Study Completion: December 15, 2024
• Last Updated: December 8, 2021

Record last verified: 2021-12

Locations

CN (2)