Metabolomics Characterization of Biomarkers of ASCVD and Prediction Model (MEAL)

December 6, 2021 updated by: Ya-Wei Xu, Shanghai 10th People's Hospital
  1. Describe the risk factors and metabonomics characteristics of atherosclerotic cardiovascular disease in Chinese patients.
  2. Establish accurate prediction model of atherosclerotic heart disease.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

1869

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200072
        • Recruiting
        • Shanghai Tenth People's Hospital
        • Contact:
      • Shanghai, China, 200072
        • Not yet recruiting
        • Department of Cardiology,Shanghai Tenth People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolomics Characterization of Biomarkers
Time Frame: 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.
3 years
Coronary vascularization.
Time Frame: 3 years
Coronary vascularization includes percutaneous coronary intervention, or/and percutaneous coronary artery dilatation, or/and percutaneous coronary artery bypass grafting.
3 years
All cause mortality
Time Frame: 3 years
which refers to the total death caused by various causes in a certain period.
3 years
Cardiac mortality
Time Frame: 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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai 10th People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 15, 2021

Primary Completion (Anticipated)

December 15, 2024

Study Completion (Anticipated)

December 15, 2024

Study Registration Dates

First Submitted

November 5, 2021

First Submitted That Met QC Criteria

December 6, 2021

First Posted (Actual)

December 8, 2021

Study Record Updates

Last Update Posted (Actual)

December 8, 2021

Last Update Submitted That Met QC Criteria

December 6, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEAL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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