Multi-omics Merge for Ensemble Subtyping for Atherosclerotic Cardiovascular Disease

NCT06471803 | Not Yet Recruiting DMC

• 1 other identifier: ASCVD-MOMENT-TYPING
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Atherosclerotic Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• ACM

  All-cause mortality

  1-3 years

Secondary Outcomes (1)

• MACE

  1-3 years

Study Arms (4)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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

You may not qualify if:

• 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
• severe infectious or contagious disease
• autoimmune disease
• age \<18 years
• patients with incomplete clinical records

Sponsors & Collaborators

• Henan Province Clinical Research Center for Cardiovascular Diseases: lead

Study Sites (1)

Department of Cardiology, The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450018, China

Location

Study Officials

• Junnan Tang, Director

  Department of Cardiology, The First Affiliated Hospital of Zhengzhou University

  STUDY CHAIR

Central Study Contacts

Junnan Tang, Chair

CONTACT

+86 37166295219; fcctangjn@zzu.edu.cn

Jinying Zhang, Director

CONTACT

jyzhang@zzu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Henan Province Clinical Research Center for Cardiovascular Diseases

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: June 24, 2024
• Study Start: September 1, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)