Innate Immune Cell Phenotypes and Early Fibrotic Repair in Acute Myocardial Infarction

NCT07764588 — Recruiting, 50 participants, Shanghai 10th People's Hospital

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RegistryNCT07764588, acronym ICE-AMI
StatusRecruiting
Study typeObservational
Enrollment50 (Estimated)
SponsorShanghai 10th People's Hospital (Other)
ConditionsMyocardial Infarction
Datesstart 2026-01-01, primary completion 2026-12-31 (estimated), completion 2026-12-31 (estimated), first posted 2026-08-14, last updated 2026-08-14
Locations1 site in China

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-Summary

To determine the relationship of the phenotypes of neutrophils and monocytes with early fibrotic repair after acute myocardial infarction.

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+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).

+Arms and interventions

ArmTypeInterventionsDescription
STEMI patientsPatients with acute STEMI within 12 hours of symptom onset receive primary percutaneous coronary intervention.

+Outcome measures

Primary outcomes

  • Major cardiac adverse outcome [At 12 months after enrollment]: The composite endpoint included cardiac death, non-fatal myocardial infarction, and rehospitalization for angina.

Secondary outcomes

  • Cardiac remodeling measured by CMR [At 1 week after admission]: CMR will be performed to evaluate the cardiac fibrosis defined as area of late gadolinium enhancement (LGE).

+Eligibility

Sex: All, ages: 18 Years to 80 Years

Inclusion Criteria:

\---- Age > 18 and ≤ 80 years old

\- Patients with acute STEMI within 12 hours of symptom onset who are planned to receive PPCI

Exclusion Criteria:

* 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)

+Locations (1)

FacilityCityCountryStatus
Shanghai Tenth People's HospitalShanghaiChinaRecruiting