Clinical trial NCT06994221: Fibrosis Assessment in Myocardial Infarction-associated Ventricular Aneurysm
Official title: Assessment of Myocardial Fibrosis by 18F-FAPI/PET-CT in Patients With Myocardial Infarction-associated Ventricular Aneurysm
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Myocardial Infarction
Ventricular Aneurysm Following Acute Myocardial Infarction
Myocardial Fibrosis
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2025-05-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Enrolled patients are expected to be diagnosed with ventricular aneurysm secondary to acute myocardial infarction (AMI), and 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.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: FAPI uptake (SUV max)
timeFrame: Day 1 after the PET/CT scan.
measure: FAPI uptake (SUV mean)
timeFrame: Day 1 after the PET/CT scan.
Secondary outcomes:
measure: Cardiac function assessed by echocardiography
timeFrame: Day 1 after the PET/CT scan, and at 1-month, 6-month and 1-year follow-ups
measure: The event rate of heart failure
timeFrame: From date of enrollment until the date of follow-ups at 1 month, 6 month and 1 year post discharge.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
Study officials:
References: