ClinicalTrials.gg
RecruitingNCT06885619Updated May 12, 2026

Prediction of LVAR and MACE in STEMI Though Plasma Multiomics Analysis

An observational study in Left Ventricular Remodeling, Plasma Multi-Omics and Acute ST-segment Elevation Myocardial Infarction, sponsored by Beijing Anzhen Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-12.

Sponsored by Beijing Anzhen Hospital · Observational

From the registry’s dates

  • Started May 2025; still recruiting 1 year 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Left Ventricular Remodeling
  • Plasma Multi-Omics
  • Acute ST-segment Elevation Myocardial Infarction
  • Immunomics
  • Major Adverse Cardiovascular Events
03

In context

Ventricular Remodeling

105 studies on the registry are indexed under Ventricular Remodeling; 24 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 180 across 32 observational studies indexed under Ventricular Remodeling.

Browse Ventricular Remodeling studies →

Lead sponsor

Beijing Anzhen Hospital is the lead sponsor of 192 studies on the registry; 102 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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. (by echocardiography within 24-48 hours after admission) ≥35%.
  6. : Signed informed consent obtained, with willingness to undergo serial blood sampling and echocardiographic follow-up.

Exclusion criteria

Exclusion Criteria:

  1. Non-atherosclerotic MI: coronary embolism, spasm, aortic dissection, myocarditis, Takotsubo.
  2. Severe comorbidities:

    • Prior HF ( ≥II);
    • Severe CKD ( \<30 mL/min/1.73m² or dialysis);
    • Severe liver disease ( B/C);
    • Active ( \<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.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • 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.

06

What researchers measure

Primary outcomes

  1. major adverse cardiovascular events

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

    Time frame: From enrollment to 36 months.

Secondary outcomes

  1. 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.

    Time frame: From enrollment to 6 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06885619
Collaborators
Beijing Jishuitan Hospital, Chinese Academy of Sciences
Responsible party
Sponsor
First posted
Mar 20, 2025
Start date
May 1, 2025
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
May 12, 2026

Study contacts

Xu Wang, Dr.
Contact
huaianwangxu@126.com
+8617810688257
Xu Wang, Dr.
principal investigator · Beijing Anzhen hospital, Capital Mediacl University.
Tanxi Cai, Dr.
study director · Chinese Academy of Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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