Fibrosis Assessment in Myocardial Infarction-associated Ventricular Aneurysm
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 18F FAPI-42 PET/CT scan.
- Who it may be relevant to
- Registry conditions: Acute Myocardial Infarction, Ventricular Aneurysm Following Acute Myocardial Infarction, Myocardial Fibrosis. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessment of Myocardial Fibrosis by 18F-FAPI/PET-CT in Patients With Myocardial Infarction-associated Ventricular Aneurysm
Overview
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 test 18F 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)
Primary outcome measures
- FAPI uptake (SUV max) [Time frame: Day 1 after the PET/CT scan.]
- FAPI uptake (SUV mean) [Time frame: Day 1 after the PET/CT scan.]
Secondary outcome measures (2)
- 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]
- 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.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Renji Hospital — Shanghai
Identifiers
NCT: NCT06994221 · EARLY-MYO FAPI-PET/CT