Fibrosis Assessment in Myocardial Infarction-associated Ventricular Aneurysm

NCT06994221 | Recruiting

• 1 other identifier: EARLY-MYO FAPI-PET/CT
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myocardial Infarction; Ventricular Aneurysm Following Acute Myocardial Infarction; Myocardial Fibrosis

Outcome Measures

Primary Outcomes (2)

• FAPI uptake (SUV max)

  FAPI uptake is assessed by drawing regions of interest (ROI), and determined as the maximal standard uptake value (SUVmax).

  Day 1 after the PET/CT scan.

• FAPI uptake (SUV mean)

  FAPI uptake is assessed by drawing regions of interest (ROI), and determined as the mean standard uptake value (SUVmean).

  Day 1 after the PET/CT scan.

Secondary Outcomes (2)

• Cardiac function assessed by echocardiography

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

• The event rate of heart failure

  From date of enrollment until the date of follow-ups at 1 month, 6 month and 1 year post discharge.

Study Arms (2)

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).

Diagnostic Test: 18F FAPI-42 PET/CT scan

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.

Diagnostic Test: 18F FAPI-42 PET/CT scan

Interventions

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)

Acute myocardial infarction without evidence of ventricular aneurysm; Acute myocardial infarction-associated ventricular aneurysm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients under the age of 18 years old;
• Patients who are pregnant/breastfeeding;
• Patients who has a previous history of allergy to radio tracers.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital

Shanghai, 200127, China

RECRUITING

Central Study Contacts

ZHIGUO ZOU, MD, PhD

CONTACT

13524596108; zouzhiguo@renji.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: May 29, 2025
• Study Start: November 1, 2024
• Primary Completion: July 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Locations

CN (1)