Myocardial InfarctionICE-AMINCT07764588
Innate Immune Cell Phenotypes and Early Fibrotic Repair in Acute Myocardial Infarction
An observational study of Myocardial Infarction, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
To determine the relationship of the phenotypes of neutrophils and monocytes with early fibrotic repair after acute myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myocardial Infarction
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Dec 2026
- 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: STEMI patients undergoing PPCI
Who may be able to join
- ---- Age > 18 and ≤ 80 years old
- Patients with acute STEMI within 12 hours of symptom onset who are planned to receive PPCI
Who cannot join
- Prior revascularization
- Known allergy to gadopentetate dimeglumine contrast agent
- Pregnancy or planned pregnancy within the next 6 months
- Life expectancy < 1 year
- Metallic implants or claustrophobia that precluded MRI
- Severe COPD or inability to hold breath for MRI
- Severe hepatic or renal dysfunction (ALT > 5×ULN or eGFR < 15 mL/min/1.73 m²)
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
Shanghai Tenth People's Hospital
Shanghai
Ethics Committee of Shanghai Tenth People's Hospital, 86-21-66301604, jh_zhuang@tongji.edu.cn
About this study
To determine the relationship of the phenotypes of neutrophils and monocytes with early fibrotic repair after acute myocardial infarction.
Read the detailed description
This study will enroll 50 patients with ST-segment elevation myocardial infarction (STEMI). Peripheral blood will be collected from these patients for immune cell subset analysis, serum cytokine evaluation, and neutrophil sorting for transcriptome sequencing. At 1 week after admission, cardiac magnetic resonance (CMR) will be performed to evaluate the myocardial salvage index, area of late gadolinium enhancement (LGE), microvascular obstruction (MVO), extracellular volume (ECV), and left ventricular ejection fraction (LVEF).
- Conditions
- Myocardial Infarction
- Keywords
- neutrophil, monocyte, myocardial infarction, cardiac remodeling, cardiac magnetic resonance
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| STEMI patients | Patients with acute STEMI within 12 hours of symptom onset receive primary percutaneous coronary intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major cardiac adverse outcome
The composite endpoint included cardiac death, non-fatal myocardial infarction, and rehospitalization for angina.
Measured: At 12 months after enrollment
Secondary outcomes (1)
Cardiac remodeling measured by CMR
CMR will be performed to evaluate the cardiac fibrosis defined as area of late gadolinium enhancement (LGE).
Measured: At 1 week after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Zhang, MD, PhD, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07764588
- Sponsor's protocol ID
- ICE-AMI
- Other IDs
- 82370337
- Acronym
- ICE-AMI
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We need preparation.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innate Immune Cell Phenotypes and Early Fibrotic Repair in Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT07764588
- Acronym / sponsor ID
- ICE-AMI / ICE-AMI
- Conditions
- Myocardial Infarction
- Keywords
- neutrophil, monocyte, myocardial infarction, cardiac remodeling, cardiac magnetic resonance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Aug 2026 (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 determine the relationship of the phenotypes of neutrophils and monocytes with early fibrotic repair after acute myocardial infarction.
Detailed description
This study will enroll 50 patients with ST-segment elevation myocardial infarction (STEMI). Peripheral blood will be collected from these patients for immune cell subset analysis, serum cytokine evaluation, and neutrophil sorting for transcriptome sequencing. At 1 week after admission, cardiac magnetic resonance (CMR) will be performed to evaluate the myocardial salvage index, area of late gadolinium enhancement (LGE), microvascular obstruction (MVO), extracellular volume (ECV), and left ventricular ejection fraction (LVEF).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STEMI patients | – | –Patients with acute STEMI within 12 hours of symptom onset receive primary percutaneous coronary intervention. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- STEMI patients undergoing PPCI
Key inclusion criteria (2 listed)
- ---- Age > 18 and ≤ 80 years old
- Patients with acute STEMI within 12 hours of symptom onset who are planned to receive PPCI
Key exclusion criteria (7 listed)
- Prior revascularization
- Known allergy to gadopentetate dimeglumine contrast agent
- Pregnancy or planned pregnancy within the next 6 months
- Life expectancy < 1 year
- Metallic implants or claustrophobia that precluded MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major cardiac adverse outcome
Time frame: At 12 months after enrollment
The composite endpoint included cardiac death, non-fatal myocardial infarction, and rehospitalization for angina.
1 secondary outcome
Cardiac remodeling measured by CMR
Time frame: At 1 week after admission
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 14 Aug 2026.
- Individual participant dataSharing planned: Undecided. We need preparation.
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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.
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 Myocardial Infarction, run by Shanghai 10th People's 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 2 inclusion and 7 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 14 Aug 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 Jianhui Zhuang, MD (86-13621742833, jh_zhuang@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major cardiac adverse outcome (time frame: At 12 months after enrollment). 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 14 Aug 2026.