Fibrosis Assessment in Myocardial Infarction-associated Ventricular Aneurysm

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Myocardial Fibrosis; Acute Myocardial Infarction; Ventricular Aneurysm Following Acute Myocardial Infarction

Treatments: Diagnostic Test: 18F FAPI-42 PET/CT scan

Study type: Observational

Funder types: Other

Identifiers

NCT06994221

EARLY-MYO FAPI-PET/CT

Details and patient eligibility

About

The study will use 18F-FAPI PET/CT to study myocardial fibrosis in patients diagnosed with myocardial infarction-associated ventricular aneurysm (MI-VA). Participants will receive the PET/CT scan during hospital stay, as well as serial echocardiography and telephonic follow-ups. Analysed will focus on the characterization of myocardial fibrosis and its correlations with the clinical prognosis in the patients.

Full description

The aim of this study is to investigate the temporal and spatial distribution of myocardial fibrosis in patients diagnosed with myocardial infarction-associated ventricular aneurysm using the novel fibroblast activation imaging tracer 18F FAPI-42 with PET/CT. This imaging modality allows for non-invasive visualization of activated fibroblasts, which are a key component of myocardial fibrotic remodeling after infarction.

The study is expected to enroll patients diagnosed with ventricular aneurysm secondary to acute myocardial infarction (AMI), who are hospitalized at Renji Hospital, Shanghai Jiao Tong University School of Medicine. The investigators expect to enroll 20 patients diagnosed with MI-VA and 10 AMI patients without evidence of ventricular aneurysm. With written informed consent, the investigators will review past medical records and document the medical history for each participant. During the hospital stay, participants will receive an 18F FAPI-42 PET/CT scan. FAPI uptake in the ventricular aneurysm and remote myocardium will be calculated as maximum standardized uptake value (SUVmax) and mean standardized uptake value (SUVmean). Correlation between SUVmax/SUVmean and critical markers of the disease progression, such as B-type natriuretic peptide (BNP) and cardiac troponin I (cTnI), will be analysed by Pearson or Spearman correlation coefficients. All participants will be followed for 1 year after enrolment, and serial echocardiography and telephonic follow-up will be performed. Major adverse cardiovascular events (MACE) will be recorded throughout the follow-up to reveal any predictive values of 18F-FAPI PET/C-assessed fibrosis for the patients with MI-VA.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18-75 years old
• Diagnosed with STEMI or NSTEMI (ACC/AHA guidelines)
• Half male and half female
• Undergo CAG and PCI treatment;
• Receive either echocardiography or CMR to identify a ventricular aneurysm;
• Written informed consent

Exclusion criteria

• Patients under the age of 18 years old;
• Patients who are pregnant/breastfeeding;
• Patients who has a previous history of allergy to radio tracers.

Trial design

20 participants in 2 patient groups

Acute myocardial infarction-associated ventricular aneurysm

Description:

Participants in this group are patients diagnosed with a ventricular aneurysm secondary to acute myocardial infarction (AMI). Diagnosis of AMI is based on clinical presentation, elevated cardiac biomarkers, ECG changes, and coronary angiogram. Ventricular aneurysm is mainly diagnosed by imaging modalities such as echocardiography and cardiovascular magnetic resonance (CMR).

Treatment:

Diagnostic Test: 18F FAPI-42 PET/CT scan

Acute myocardial infarction without evidence of ventricular aneurysm

Description:

Participants in this group are patients diagnosed with AMI only. Diagnosis of AMI is based on clinical presentation, elevated cardiac biomarkers, ECG changes, and coronary angiogram. Echocardiography or CMR does not identify a ventricular aneurysm.

Treatment:

Diagnostic Test: 18F FAPI-42 PET/CT scan