Left Ventricular RemodelingNCT06885619
Prediction of LVAR and MACE in STEMI Though Plasma Multiomics Analysis
An observational study of Left Ventricular Remodeling and Plasma Multi-Omics, run by Beijing Anzhen Hospital at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Left Ventricular Remodeling, Plasma Multi-Omics, Acute ST-segment Elevation Myocardial Infarction
- What is being tested?
- Diagnostic Test: echocardiography and blood collection
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital, Capital Medical University.
Beijing, Beijing Municipality, 100029
Xu Wang, Dr., +8617810688257, huaianwangxu@126.com
Xu Wang, Dr.
About this study
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
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.
- Conditions
- Left Ventricular Remodeling, Plasma Multi-Omics, Acute ST-segment Elevation Myocardial Infarction, Immunomics, Major Adverse Cardiovascular Events
- Being tested
- Diagnostic Test: echocardiography and blood collection
- Medical subject headings
- Ventricular Remodeling, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Test: echocardiography and blood collectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with STEMI | First-STEMI patients treated with primary PCI (symptom-to-PCI ≤12 h, TIMI 3) were enrolled within 24 h post-PCI. Receives: Other: Diagnostic Test: echocardiography and blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
major adverse cardiovascular events
Identify T0 plasma multi-omics biomarkers that predict cardiac death, myocardial infarction, heart failure, and stroke.
Measured: 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.
Measured: From enrollment to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start1 May 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular RemodelingStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Jishuitan Hospital, Chinese Academy of Sciences
- Responsible party
- Sponsor
- Investigators
- Xu Wang, Dr., Principal investigator, Beijing Anzhen hospital, Capital Mediacl University.Tanxi Cai, Dr., Study director, Chinese Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06885619
- Sponsor's protocol ID
- KS2025013
- Status last verified
- Apr 2026
- First submitted
- 14 Mar 2025
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06885619
- Acronym / sponsor ID
- KS2025013
- Conditions
- Left Ventricular Remodeling, Plasma Multi-Omics, Acute ST-segment Elevation Myocardial Infarction, Immunomics, Major Adverse Cardiovascular Events
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Collaborators
- Beijing Jishuitan Hospital, Chinese Academy of Sciences
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with STEMI | – | Other: Diagnostic Test: echocardiography and blood collectionFirst-STEMI patients treated with primary PCI (symptom-to-PCI ≤12 h, TIMI 3) were enrolled within 24 h post-PCI. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- Age ≥18 years and ≤80 years.
- Definite diagnosis of STEMI according to ESC/ACC guidelines:
- 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%.
Key exclusion criteria (18 listed)
- Non-atherosclerotic MI: coronary embolism, spasm, aortic dissection, myocarditis, Takotsubo.
- Severe comorbidities:
- Fibrinolysis-followed-by-PCI.
- Primary PCI complications:
- Inability to complete 6-month follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic Test: echocardiography and blood collectionBlood 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. | Other | Patients with STEMI |
Primary outcome
major adverse cardiovascular events
Time frame: From enrollment to 36 months.
Identify T0 plasma multi-omics biomarkers that predict cardiac death, myocardial infarction, heart failure, and stroke.
1 secondary outcome
adverse cardiac remodeling
Time frame: From enrollment to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xu Wang, Dr. principal investigator
Beijing Anzhen hospital, Capital Mediacl University.
Tanxi Cai, Dr. study director
Chinese Academy of Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Ventricular Remodeling and Plasma Multi-Omics, run by Beijing Anzhen Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xu Wang, Dr. (+8617810688257, huaianwangxu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
major adverse cardiovascular events (time frame: From enrollment to 36 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.