Prediction of LVAR and MACE in STEMI Though Plasma Multiomics Analysis

NCT06885619 | Recruiting DMC

• 1 other identifier: KS2025013
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• major adverse cardiovascular events

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

  From enrollment to 36 months.

Secondary Outcomes (1)

• adverse cardiac remodeling

  From enrollment to 6 months

Study Arms (1)

Patients with STEMI

First-STEMI patients treated with primary PCI (symptom-to-PCI ≤12 h, TIMI 3) were enrolled within 24 h post-PCI.

Other: Diagnostic Test: echocardiography and blood collection

Interventions

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.

Patients with STEMI

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population includes individuals diagnosed with acute ST-segment elevation myocardial infarction (MI), selected by the site personnel according to predefined inclusion criteria. The cohort comprises 1,000 patients, whose baseline clinical characteristics and plasma biomarkers will be assessed.

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead
• Beijing Jishuitan Hospital: collaborator
• Institute of Biophysics, Chinese Academy of Sciences: collaborator

Study Sites (1)

Beijing Anzhen Hospital, Capital Medical University.

Beijing, Beijing Municipality, 100029, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood samples were centrifuged to separate plasmathe and peripheral blood mononuclear cells (PBMC), which was then aliquoted and stored at -80°C for long-term preservation

MeSH Terms

Conditions

Ventricular Remodeling; ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Necrosis

Study Officials

• Xu Wang, Dr.

  Beijing Anzhen hospital, Capital Mediacl University.

  PRINCIPAL INVESTIGATOR

• Tanxi Cai, Dr.

  Institute of Biophysics, Chinese Academy of Sciences

  STUDY DIRECTOR

Central Study Contacts

Xu Wang, Dr.

CONTACT

+8617810688257; huaianwangxu@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 20, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-04

Locations

CN (1)