Atherosclerotic Cardiovascular DiseasesASCVD-MOMENTNCT06471803
Multi-omics Merge for Ensemble Subtyping for Atherosclerotic Cardiovascular Disease
An observational study of Atherosclerotic Cardiovascular Diseases, run by Henan Province Clinical Research Center for Cardiovascular Diseases at 1 site in China.
Trial summary
The current biological issues driving the evolutionary progression of coronary artery disease are in focus: at this stage, the biological evidence for them is scarce and small in scale, with the exception of metabolomics and microbiomics. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atherosclerotic Cardiovascular Diseases
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 1 Mar 2026
- How long will I take part?
- 2 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The investigators aim to collect a population of patients with atherosclerotic heart disease who met inclusion exclusion criteria for four clinical phenotypes/groups (AMI, US, CCS, NCA).
Who may be able to join
- aged more than 18 years
- meet the diagnostic criteria of coronary heart disease
- undergo coronary angiography after admission and have at least 50% stenosis in at least one major coronary artery
- able to sign the informed consent form
Who cannot join
- severe valvular disease (defined as valvular disease stage C or D)
- hypertrophic cardiomyopathy; pulmonary heart disease 2) gastrointestinal disease
- hyperthyroidism, anemia, or any other high-intensity heart disease
- malignant tumors
- severe dysfunction of the liver (defined as alanine aminotransferase or total bilirubin greater than 3 times the upper limit of normal) or kidney (defined as eGFR) >20 mL/min/1.73m2 or requiring dialysis)
- severe congenital heart disease
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- severe infectious or contagious disease
- autoimmune disease
- age <18 years
- patients with incomplete clinical records
Trial locations and contacts
1 site in 1 country.
Jinying Zhang, Director contact
China1 site
Department of Cardiology, The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450018
About this study
Official title: Multi-omics Merge for Ensemble Subtyping for Atherosclerotic Cardiovascular Disease and Related Mechanism Study
The current biological issues driving the evolutionary progression of coronary artery disease are in focus: at this stage, the biological evidence for them is scarce and small in scale, with the exception of metabolomics and microbiomics. Issues such as histologic mapping of coronary atherosclerosis deterioration remain to be corroborated by more clinical and basic evidence! By analyzing the clinical data and multi-omics data of patients with coronary heart disease, investigators will explore the related risk factors and establish molecular subtypes and prognostic prediction models for individualized prediction of coronary heart disease risk, in order to guide the clinical screening of high-risk groups of coronary heart disease and formulate more targeted intervention countermeasures.
Read the detailed description
The biological mechanisms driving the progression of coronary artery disease (CAD) are complex and multifaceted. While there have been significant advances in understanding these mechanisms, much of the biological evidence remains limited and fragmented, especially beyond the realms of metabolomics and microbiomics. For instance, the detailed histologic mapping of the deterioration of coronary atherosclerosis still requires more extensive clinical and basic research to substantiate initial findings.
To address these gaps, researchers are turning to comprehensive analyses of clinical and multi-omics data from patients with coronary heart disease. This involves a deep dive into various data types, including genomics, proteomics, metabolomics, and microbiomics, to identify potential risk factors associated with CAD. By integrating these data, investigators aim to uncover molecular subtypes of the disease that can provide a more nuanced understanding of its progression.
Furthermore, the goal is to develop robust prognostic prediction models that can accurately forecast the risk of CAD in individual patients. These models will leverage the identified molecular subtypes and associated risk factors to offer personalized predictions, which are crucial for effective clinical decision-making. Through this individualized approach, it will be possible to enhance the screening processes for high-risk groups and design more precise and effective intervention strategies.
Ultimately, this research endeavors to bridge the gap between basic scientific discoveries and clinical applications, paving the way for tailored therapeutic interventions that can significantly improve patient outcomes in coronary artery disease.
- Conditions
- Atherosclerotic Cardiovascular Diseases
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 |
|---|---|---|
| acute myocardial infarction (AMI) | acute myocardial infarction | |
| Unstable angina (UA) | Unstable angina | |
| chronic coronary syndrome (CCS) | chronic coronary syndrome | |
| normal coronary artery (NCA) | normal coronary artery |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACM
All-cause mortality
Measured: 1-3 years
Secondary outcomes (1)
MACE
Major cardiovascular events
Measured: 1-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Cardiovascular DiseasesStudies 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
- 500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Henan Province Clinical Research Center for Cardiovascular Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ge Zhang, Henan Province Clinical Research Center for Cardiovascular Diseases
- Investigators
- Junnan Tang, Director, Study chair, Department of Cardiology, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06471803
- Sponsor's protocol ID
- ASCVD-MOMENT-TYPING
- Acronym
- ASCVD-MOMENT
- Status last verified
- Jun 2024
- First submitted
- 18 Jun 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-omics Merge for Ensemble Subtyping for Atherosclerotic Cardiovascular Disease and Related Mechanism Study
- ClinicalTrials.gov ID
- NCT06471803
- Acronym / sponsor ID
- ASCVD-MOMENT / ASCVD-MOMENT-TYPING
- Conditions
- Atherosclerotic Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Henan Province Clinical Research Center for Cardiovascular DiseasesUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 24 Jun 2024 (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.
The current biological issues driving the evolutionary progression of coronary artery disease are in focus: at this stage, the biological evidence for them is scarce and small in scale, with the exception of metabolomics and microbiomics. Issues such as histologic mapping of coronary atherosclerosis deterioration remain to be corroborated by more clinical and basic evidence! By analyzing the clinical data and multi-omics data of patients with coronary heart disease, investigators will explore the related risk factors and establish molecular subtypes and prognostic prediction models for individualized prediction of coronary heart disease risk, in order to guide the clinical screening of high-risk groups of coronary heart disease and formulate more targeted intervention countermeasures.
Detailed description
The biological mechanisms driving the progression of coronary artery disease (CAD) are complex and multifaceted. While there have been significant advances in understanding these mechanisms, much of the biological evidence remains limited and fragmented, especially beyond the realms of metabolomics and microbiomics. For instance, the detailed histologic mapping of the deterioration of coronary atherosclerosis still requires more extensive clinical and basic research to substantiate initial findings.
To address these gaps, researchers are turning to comprehensive analyses of clinical and multi-omics data from patients with coronary heart disease. This involves a deep dive into various data types, including genomics, proteomics, metabolomics, and microbiomics, to identify potential risk factors associated with CAD. By integrating these data, investigators aim to uncover molecular subtypes of the disease that can provide a more nuanced understanding of its progression.
Furthermore, the goal is to develop robust prognostic prediction models that can accurately forecast the risk of CAD in individual patients. These models will leverage the identified molecular subtypes and associated risk factors to offer personalized predictions, which are crucial for effective clinical decision-making. Through this individualized approach, it will be possible to enhance the screening processes for high-risk groups and design more precise and effective intervention strategies.
Ultimately, this research endeavors to bridge the gap between basic scientific discoveries and clinical applications, paving the way for tailored therapeutic interventions that can significantly improve patient outcomes in coronary artery disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| acute myocardial infarction (AMI) | – | –acute myocardial infarction |
| Unstable angina (UA) | – | –Unstable angina |
| chronic coronary syndrome (CCS) | – | –chronic coronary syndrome |
| normal coronary artery (NCA) | – | –normal coronary artery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The investigators aim to collect a population of patients with atherosclerotic heart disease who met inclusion exclusion criteria for four clinical phenotypes/groups (AMI, US, CCS, NCA).
Key inclusion criteria (4 listed)
- aged more than 18 years
- meet the diagnostic criteria of coronary heart disease
- undergo coronary angiography after admission and have at least 50% stenosis in at least one major coronary artery
- able to sign the informed consent form
Key exclusion criteria (10 listed)
- severe valvular disease (defined as valvular disease stage C or D)
- hypertrophic cardiomyopathy; pulmonary heart disease 2) gastrointestinal disease
- hyperthyroidism, anemia, or any other high-intensity heart disease
- malignant tumors
- severe dysfunction of the liver (defined as alanine aminotransferase or total bilirubin greater than 3 times the upper limit of normal) or kidney (defined as eGFR) >20 mL/min/1.73m2 or requiring dialysis)
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
ACM
Time frame: 1-3 years
All-cause mortality
1 secondary outcome
MACE
Time frame: 1-3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Jinying Zhang, Director contact
Junnan Tang, Director study chair
Department of Cardiology, The First Affiliated Hospital of Zhengzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerotic Cardiovascular Diseases, run by Henan Province Clinical Research Center for Cardiovascular Diseases at 1 site 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 4 inclusion and 10 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 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Junnan Tang, Chair (+86 37166295219, fcctangjn@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACM (time frame: 1-3 years). 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 25 Jun 2024.