Health TrialsbyHealthPanel

Fibrosis Assessment in Myocardial Infarction-associated Ventricular Aneurysm

ConditionsAcute Myocardial InfarctionVentricular Aneurysm Following Acute Myocardial InfarctionMyocardial Fibrosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorRenJi Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18-75 years old

Diagnosed with STEMI or NSTEMI (ACC/AHA guidelines)

Half male and half female

Undergo CAG and PCI treatment;

Disqualifiers

Patients under the age of 18 years old;

Patients who are pregnant/breastfeeding;

Patients who has a previous history of allergy to radio tracers.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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)

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Acute myocardial infarction-associated ventricular aneurysm1 intervention
Group B: Acute myocardial infarction without evidence of ventricular aneurysm1 intervention

Trial outcomes

Primary outcomes

1

FAPI uptake (SUV max)

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

Time frame
Day 1 after the PET/CT scan.
2

FAPI uptake (SUV mean)

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

Time frame
Day 1 after the PET/CT scan.

Secondary outcomes

1

Cardiac function assessed by echocardiography

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

Time frame
Day 1 after the PET/CT scan, and at 1-month, 6-month and 1-year follow-ups
2

The event rate of heart failure

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RenJi Hospital

Lead sponsor

Source ClinicalTrials.gov
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