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NCT Number: NCT06994221

Fibrosis Assessment in Myocardial Infarction-associated Ventricular Aneurysm

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

18F FAPI-42 PET/CT scan

Diagnostic Test

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)

Primary outcomes

  1. FAPI uptake (SUV max)

    Time frame: 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).

  2. FAPI uptake (SUV mean)

    Time frame: 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 outcomes

  1. Cardiac function assessed by echocardiography

    Time frame: Day 1 after the PET/CT scan, and at 1-month, 6-month and 1-year follow-ups

    Cadiac function is evaluated as left ventricular ejection fraction (LVEF, %) by echocardiography

  2. The event rate of heart failure

    Time frame: From 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.

Study contacts

Contact information is provided by the study sponsor or research team.

ZHIGUO ZOU, MD, PhD

CONTACT

[email protected]

13524596108

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 29, 2025
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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