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

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.

Study Overview

• Status: Recruiting
• Conditions: Major Adverse Cardiovascular Events; Left Ventricular Remodeling; Acute ST-segment Elevation Myocardial Infarction; Plasma Multi-Omics; Immunomics
• Intervention / Treatment: Other: Diagnostic Test: echocardiography and blood collection

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Xu Wang, Dr.; Phone Number: +8617810688257; Email: huaianwangxu@126.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100029
      • Recruiting
      • Beijing Anzhen Hospital, Capital Medical University.
      • Contact: Xu Wang, Dr.; Phone Number: +8617810688257; Email: huaianwangxu@126.com
      • Principal Investigator: Xu Wang, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse cardiac remodeling	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.	From enrollment to 6 months

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital
• Collaborators: Beijing Jishuitan Hospital; Institute of Biophysics, Chinese Academy of Sciences
• Investigators: Principal Investigator: Xu Wang, Dr., Beijing Anzhen hospital, Capital Mediacl University.; Study Director: Tanxi Cai, Dr., Institute of Biophysics, Chinese Academy of Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 14, 2025
• First Submitted That Met QC Criteria: March 14, 2025
• First Posted (Actual): March 20, 2025

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Anatomical; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Myocardial Infarction; Ischemia; Pathological Conditions, Signs and Symptoms; ST Elevation Myocardial Infarction; Ventricular Remodeling
• Other Study ID Numbers: KS2025013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No