Fibrosis Assessment in Myocardial Infarction-associated Ventricular Aneurysm
NCT ID: NCT06994221
Last Updated: 2025-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
20 participants
OBSERVATIONAL
2024-11-01
2025-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Acute myocardial infarction-associated ventricular aneurysm
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).
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)
Acute myocardial infarction without evidence of ventricular aneurysm
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.
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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 who are pregnant/breastfeeding;
* Patients who has a previous history of allergy to radio tracers.
18 Years
75 Years
ALL
No
Sponsors
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RenJi Hospital
OTHER
Responsible Party
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Zhiguo Zou
Doctor
Locations
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Renji Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EARLY-MYO FAPI-PET/CT
Identifier Type: -
Identifier Source: org_study_id
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