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NCT Number: NCT06885619

Prediction of LVAR and MACE in STEMI Though Plasma Multiomics Analysis

To identify plasma multi-omics biomarkers that predict left ventricular adverse remodeling (LVAR) and major adverse cardiovascular events (MACE) in patients with acute ST-segment elevation myocardial infarction, and to investigate the molecular pathways linked to LVAR and MACE.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Anzhen Hospital, Capital Medical University.

Beijing, Beijing Municipality, 100029, China

Location status: Recruiting

Location contact

Xu Wang, Dr.

CONTACT

[email protected]

+8617810688257

Xu Wang, Dr.

PRINCIPAL_INVESTIGATOR

About this study

Despite advances in AMI treatment, a substantial proportion of patients develop LVAR, leading to heart failure and increased MACE risk. Conventional biomarkers (e.g., troponin, NT-proBNP) lack sufficient predictive power for adverse outcomes. Multi-omics approaches - integrating proteomics(e.g., exosome proteomics), metabolomics, transcriptomics ,lipidomics and Immunomics- offer a systems-level view that may uncover novel prognostic signatures.

Prospective blood sampling was performed in a cohort of first-STEMI patients treated with primary PCI. After 6-month follow-up, patients with left ventricular adverse remodeling (cases) were matched with non-remodeling controls (nested case-control design) for multi-omics analysis (exosome, immune, proteome) using the pre-collected serial blood samples.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years and ≤80 years.
  • Definite diagnosis of STEMI according to ESC/ACC guidelines:
  • Chest pain lasting >30 minutes, and
  • ST-segment elevation in at least two contiguous leads: ≥0.2 mV in leads V2-V3 (≥0.2 mV for men, ≥0.15 mV for women) or ≥0.1 mV in other leads, or new-onset left bundle branch block.
  • Reperfusion therapy: Symptom onset to first medical contact ≤12 hours, and successful primary PCI (culprit vessel opened, post-procedure TIMI flow grade 3).
  • First STEMI (no prior history of myocardial infarction).
  • Left ventricular ejection fraction (by echocardiography within 24-48 hours after admission) ≥35%.
  • Informed consent: Signed informed consent obtained, with willingness to undergo serial blood sampling and echocardiographic follow-up.

Exclusion criteria

  • Non-atherosclerotic MI: coronary embolism, spasm, aortic dissection, myocarditis, Takotsubo.
  • Severe comorbidities:
  • Prior HF (NYHA ≥II);
  • Severe CKD (eGFR <30 mL/min/1.73m² or dialysis);
  • Severe liver disease (Child-Pugh B/C);
  • Active malignancy (life expectancy <1 year);
  • Severe hematologic disorders (thrombocytopenia, coagulopathy, active bleeding).
  • Fibrinolysis-followed-by-PCI.
  • Primary PCI complications:
  • No-reflow/slow-flow (final TIMI <2);
  • Cardiogenic shock or mechanical complication within 7 days;
  • In-hospital repeat revascularization.
  • Inability to complete 6-month follow-up.
  • Factors affecting blood sampling/exosome/immune/proteome assays:
  • Blood transfusion within 1 month;
  • Known hemolytic disorder;
  • Inadequate venous access.
  • Pregnancy or lactation.

Treatment and study plan

Diagnostic Test: echocardiography and blood collection

Other

Blood samples were collected from all patients at enrollment (within 24 hours after primary PCI), at days 3-5, and at months 1, 3, and 6 after enrollment. Echocardiography was performed at enrollment (baseline, within 24-48 hours after admission), and at months 1, 3, and 6 after enrollment.

Primary outcomes

  1. major adverse cardiovascular events

    Time frame: From enrollment to 36 months.

    Identify T0 plasma multi-omics biomarkers that predict cardiac death, myocardial infarction, heart failure, and stroke.

Secondary outcomes

  1. adverse cardiac remodeling

    Time frame: From enrollment to 6 months

    To assess the predictive ability of multi-omics biomarkers in T0 plasma for adverse cardiac remodeling, and to identify new candidate markers for forecasting this condition.

Study contacts

Contact information is provided by the study sponsor or research team.

Xu Wang, Dr.

CONTACT

[email protected]

+8617810688257

Sponsors and collaborators

Lead sponsor

Beijing Anzhen Hospital

Other

Collaborators

  • Beijing Jishuitan Hospital
  • Institute of Biophysics, Chinese Academy of Sciences

Registry information

Official study title

Prediction of Left Ventricular Adverse Remodeling and Major Adverse Cardiovascular Events in Patients With Acute ST-segment Elevation Myocardial Infarction Though Plasma Multiomics Analysis

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 20, 2025
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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