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Fibrosis Assessment in Myocardial Infarction-associated Ventricular Aneurysm

Assessment of Myocardial Fibrosis by 18F-FAPI/PET-CT in Patients With Myocardial Infarction-associated Ventricular Aneurysm

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06994221
Enrollment
20
Registered
2025-05-29
Start date
2024-11-01
Completion date
2025-12-31
Last updated
2025-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction, Myocardial Fibrosis, Ventricular Aneurysm Following Acute Myocardial Infarction

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.

Interventions

DIAGNOSTIC_TEST18F FAPI-42 PET/CT scan

During the hospital stay, participants will receive an 18F FAPI-42 PET/CT scan. 18F FAPI-42 is a new fibroblast activation protein (FAP)-specific tracer used for fibrosis imaging. PET/CT will be performed using the ultra-high-resolution digital PET/CT uEXPLORER (United Imaging, Shanghai, China)

Sponsors

RenJi Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
FAPI uptake (SUV max)Day 1 after the PET/CT scan.FAPI uptake is assessed by drawing regions of interest (ROI), and determined as the maximal standard uptake value (SUVmax).
FAPI uptake (SUV mean)Day 1 after the PET/CT scan.FAPI uptake is assessed by drawing regions of interest (ROI), and determined as the mean standard uptake value (SUVmean).

Secondary

MeasureTime frameDescription
Cardiac function assessed by echocardiographyDay 1 after the PET/CT scan, and at 1-month, 6-month and 1-year follow-upsCadiac function is evaluated as left ventricular ejection fraction (LVEF, %) by echocardiography
The event rate of heart failureFrom date of enrollment until the date of follow-ups at 1 month, 6 month and 1 year post discharge.The proportion (%) of participants who experience symptomatic heart failure. Heart failure is diagnosed based on symptoms such as shortness of breath and excess fluid, in the presence of a reduced LVEF (\<60%) as assessed by echocardiography.

Countries

China

Contacts

Primary ContactZHIGUO ZOU, MD, PhD
zouzhiguo@renji.com13524596108

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026