Multi-omics search for clotting and bleeding markers in coronary heart disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will use a large, long-term Chinese cohort of patients with coronary heart disease, including those with acute coronary syndrome and patients undergoing PCI, to discover new biomarkers linked to thrombosis and major bleeding. They will analyze multiple molecular layers (proteomics, metabolomics, glycomics, genomics) plus medical imaging and clinical data. Machine learning methods will identify the most informative markers and the team will build new risk models that add these markers to existing clinical scores like GRACE, PARIS, and Precise-DAPT. The new models will be tested within the cohort to see if they predict clotting and bleeding events better than current tools.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 years.
2. Hospitalized due to symptoms or objective evidence of coronary heart disease and planned for long-term antithrombotic therapy.
3. Diagnosis of acute coronary syndrome or stable coronary heart disease undergoing percutaneous coronary intervention (PCI), with clinical stability meeting discharge criteria after treatment.
4. For patients from the existing cohort: minimum 2 years of follow-up with complete clinical data and blood specimens available; approval for use of these data and specimens has been obtained, with a waiver of re-consent.

For newly enrolled patients: voluntary written informed consent provided by the patient or legal representative, agreement to provide blood samples, and acceptance of follow-up procedures.

Exclusion Criteria:

For patients from the existing cohort:

1. Severe missing or erroneous baseline or clinical data that cannot be corrected by source verification.
2. No available blood specimen, or specimen that does not meet testing requirements.

For newly enrolled patients:

1. Presence of serious comorbid conditions with life expectancy ≤ 6 months.
2. Conditions that significantly affect study compliance or the ability to complete follow-up.
3. Contraindications to blood sampling.

Where it's running

• Fuwai Central China Cardiovascular Hospital
  Zhengzhou, Henan, China Recruiting
• General Hospital of Northern Theater Command of Chinese People's Liberation Army
  Shenyang, Liaoning, China Recruiting
• Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
  Beijing, China Recruiting

Study contacts

• Study coordinator: Xueyan Zhao, PhD
• Email: zhao_xueyan@sina.com
• Phone: +86 13683185878

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.