Prediction of LVAR and MACE in STEMI Though Plasma Multiomics Analysis

Official 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

Overview

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.

Detailed description

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.

Interventions

• Other Diagnostic Test: echocardiography and blood collection
  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 outcome measures

• major adverse cardiovascular events [Time frame: From enrollment to 36 months.]

Secondary outcome measures (1)

• adverse cardiac remodeling [Time frame: From enrollment to 6 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

China · 1 center

• Beijing Anzhen Hospital, Capital Medical University. — Beijing

Identifiers

NCT: NCT06885619 · KS2025013

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗