Plasma multi-omics prediction of left ventricular remodeling and major cardiac events after STEMI

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

This research tests whether blood multi-omics (proteins, metabolites, lipids, transcripts and immune markers) can predict left ventricular adverse remodeling (LVAR) and major adverse cardiovascular events (MACE) in adults after a first STEMI treated with primary PCI.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Beijing Anzhen Hospital (other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06885619 on ClinicalTrials.gov

What this trial studies

Investigators prospectively collected serial blood samples and performed echocardiography in adults with a first ST-segment elevation myocardial infarction (STEMI) treated by primary PCI, then followed patients for six months to identify those who developed left ventricular adverse remodeling (LVAR). Cases with LVAR were matched to non-remodeling controls in a nested case-control design and analyzed using multi-omics methods including exosome proteomics, metabolomics, transcriptomics, lipidomics and immunomics. The project integrates these data to identify plasma biomarker signatures and molecular pathways associated with LVAR and subsequent major adverse cardiovascular events (MACE). Findings aim to generate prognostic signatures that could be validated in future cohorts.

Who should consider this trial

Good fit: Adults aged 18–80 with a first STEMI treated by primary PCI within 12 hours of symptom onset, with post-procedure TIMI 3 flow and baseline echocardiographic LVEF ≥35%, who consent to serial blood draws and echocardiographic follow-up are ideal candidates.

Not a fit: Patients with prior myocardial infarction, non-atherosclerotic causes of MI (e.g., myocarditis, Takotsubo), severe comorbidities (for example advanced heart failure or severe CKD), or those unwilling/unable to undergo serial sampling and follow-up are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the approach could allow earlier identification of patients at high risk for adverse remodeling and MACE, enabling closer monitoring or targeted therapies to reduce heart failure and recurrent events.

How similar studies have performed: Multi-omics approaches in cardiovascular disease have shown promising signals for biomarker discovery in smaller cohorts, but they remain largely exploratory and not yet widely validated for routine clinical prediction of remodeling or MACE.

Eligibility criteria

Inclusion Criteria:

1. Age ≥18 years and ≤80 years.
2. 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.
3. Reperfusion therapy: Symptom onset to first medical contact ≤12 hours, and successful primary PCI (culprit vessel opened, post-procedure TIMI flow grade 3).
4. First STEMI (no prior history of myocardial infarction).
5. Left ventricular ejection fraction (by echocardiography within 24-48 hours after admission) ≥35%.
6. Informed consent: Signed informed consent obtained, with willingness to undergo serial blood sampling and echocardiographic follow-up.

Exclusion Criteria:

1. Non-atherosclerotic MI: coronary embolism, spasm, aortic dissection, myocarditis, Takotsubo.
2. 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).
3. Fibrinolysis-followed-by-PCI.
4. Primary PCI complications:

   * No-reflow/slow-flow (final TIMI \<2);
   * Cardiogenic shock or mechanical complication within 7 days;
   * In-hospital repeat revascularization.
5. Inability to complete 6-month follow-up.
6. Factors affecting blood sampling/exosome/immune/proteome assays:

   * Blood transfusion within 1 month;
   * Known hemolytic disorder;
   * Inadequate venous access.
7. Pregnancy or lactation.

Where this trial is running

Beijing, Beijing Municipality

• Beijing Anzhen Hospital, Capital Medical University. — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Xu Wang, Dr. — Beijing Anzhen hospital, Capital Mediacl University.
• Study coordinator: Xu Wang, Dr.

Conditions: Left Ventricular Remodeling, Plasma Multi-Omics, Acute ST-segment Elevation Myocardial Infarction, Immunomics, Major Adverse Cardiovascular Events