AtherosclerosisMEALNCT05148182
Metabolomics Characterization of Biomarkers of ASCVD and Prediction Model
An observational study of Atherosclerosis and Prediction Model, run by Shanghai 10th People's Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis, Prediction Model
- How many people
- 1,869 participants
- Where
- 2 sitesChina
- Study dates
- 15 Dec 2021to 15 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Not yet recruiting
Department of Cardiology,Shanghai Tenth People's Hospital
Shanghai, 200072
Yan Cang, doctor, 18917682207, cang_gu@aliyun.com
Yawei Xu, PhD, xuyawei@tongji.edu.cn
- Recruiting
Shanghai Tenth People's Hospital
Shanghai, 200072
yan cang, doctor, +86862166307219, cang_gu@aliyun.com
About this study
- Describe the risk factors and metabonomics characteristics of atherosclerotic cardiovascular disease in Chinese patients.
- Establish accurate prediction model of atherosclerotic heart disease.
Read the 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.
- Establish an accurate prediction model of atherosclerotic heart disease. Research plan：
- 1869 risk-stratified people were recruited.
- Plasma samples were collected incluing disease status and other potential influencing factors.
- 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.
- All recruited people underwent coronary angiography.
- The distribution of age and gender in each group should be matched and balanced as far as possible.
- Conditions
- Atherosclerosis, Prediction Model
- Keywords
- metabolomics, Atherosclerosis, Biomarkers, prediction model
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Coronary vascularization.
Coronary vascularization includes percutaneous coronary intervention, or/and percutaneous coronary artery dilatation, or/and percutaneous coronary artery bypass grafting.
Measured: 3 years
All cause mortality
which refers to the total death caused by various causes in a certain period.
Measured: 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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start15 Dec 2021 (estimated)
- Primary completion15 Dec 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,869 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Wei Xu, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05148182
- Sponsor's protocol ID
- MEAL
- Acronym
- MEAL
- Status last verified
- Dec 2021
- First submitted
- 5 Nov 2021
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolomics Characterization of Biomarkers of ASCVD and Prediction Model
- ClinicalTrials.gov ID
- NCT05148182
- Acronym / sponsor ID
- MEAL / MEAL
- Conditions
- Atherosclerosis, Prediction Model
- Keywords
- metabolomics, Atherosclerosis, Biomarkers, prediction model
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,869 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 15 Dec 2021 (estimated)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Describe the risk factors and metabonomics characteristics of atherosclerotic cardiovascular disease in Chinese patients.
- 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.
- Establish an accurate prediction model of atherosclerotic heart disease. Research plan：
- 1869 risk-stratified people were recruited.
- Plasma samples were collected incluing disease status and other potential influencing factors.
- 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.
- All recruited people underwent coronary angiography.
- The distribution of age and gender in each group should be matched and balanced as far as possible.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
All cause mortality
Time frame: 3 years
which refers to the total death caused by various causes in a certain period.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Department of Cardiology,Shanghai Tenth People's Hospital
Shanghai, China
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis and Prediction Model, run by Shanghai 10th People's Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolomics Characterization of Biomarkers (time frame: 3 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2021.