RecruitingNCT06885619

Prediction of LVAR and MACE in STEMI Though Plasma Multiomics Analysis

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


Sponsor

Beijing Anzhen Hospital

Enrollment

1,000 participants

Start Date

May 1, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria8

  • 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 Criteria18

  • 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.

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Interventions

OTHERDiagnostic 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.


Locations(1)

Beijing Anzhen Hospital, Capital Medical University.

Beijing, Beijing Municipality, China

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NCT06885619


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