Acute Myocardial InfarctionNCT06994221
Fibrosis Assessment in Myocardial Infarction-associated Ventricular Aneurysm
An observational study of Acute Myocardial Infarction and Ventricular Aneurysm Following Acute Myocardial Infarction, run by RenJi Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Myocardial Infarction, Ventricular Aneurysm Following Acute Myocardial Infarction, Myocardial Fibrosis
- What is being tested?
- 18F FAPI-42 PET/CT scan
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Renji Hospital
Shanghai, 200127
ZHIGUO ZOU, MD, PhD, +86 13524596108, zouzhiguo@renji.com
About this study
Official title: Assessment of Myocardial Fibrosis by 18F-FAPI/PET-CT in Patients With 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.
Read the 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.
- Conditions
- Acute Myocardial Infarction, Ventricular Aneurysm Following Acute Myocardial Infarction, Myocardial Fibrosis
- Being tested
- 18F FAPI-42 PET/CT scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F FAPI-42 PET/CT scanDiagnostic 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)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Diagnostic Test: 18F FAPI-42 PET/CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
FAPI uptake (SUV max)
FAPI uptake is assessed by drawing regions of interest (ROI), and determined as the maximal standard uptake value (SUVmax).
Measured: 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).
Measured: Day 1 after the PET/CT scan.
Secondary outcomes (2)
Cardiac function assessed by echocardiography
Cadiac function is evaluated as left ventricular ejection fraction (LVEF, %) by echocardiography
Measured: Day 1 after the PET/CT scan, and at 1-month, 6-month and 1-year follow-ups
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.
Measured: From date of enrollment until the date of follow-ups at 1 month, 6 month and 1 year post discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start1 Nov 2024
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiguo Zou, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06994221
- Sponsor's protocol ID
- EARLY-MYO FAPI-PET/CT
- Status last verified
- May 2025
- First submitted
- 20 May 2025
- Last updated
- 29 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Myocardial Fibrosis by 18F-FAPI/PET-CT in Patients With Myocardial Infarction-associated Ventricular Aneurysm
- ClinicalTrials.gov ID
- NCT06994221
- Acronym / sponsor ID
- EARLY-MYO FAPI-PET/CT
- Conditions
- Acute Myocardial Infarction, Ventricular Aneurysm Following Acute Myocardial Infarction, Myocardial Fibrosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute myocardial infarction-associated ventricular aneurysm | – | Diagnostic Test: 18F FAPI-42 PET/CT scanParticipants 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). |
| Acute myocardial infarction without evidence of ventricular aneurysm | – | Diagnostic Test: 18F FAPI-42 PET/CT scanParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (3 listed)
- Patients under the age of 18 years old;
- Patients who are pregnant/breastfeeding;
- Patients who has a previous history of allergy to radio tracers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F FAPI-42 PET/CT scanDuring 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) | Diagnostic test | Acute myocardial infarction without evidence of ventricular aneurysm, Acute myocardial infarction-associated ventricular aneurysm |
Primary outcome
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).
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).
2 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction and Ventricular Aneurysm Following Acute Myocardial Infarction, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ZHIGUO ZOU, MD, PhD (13524596108, zouzhiguo@renji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FAPI uptake (SUV max) (time frame: Day 1 after the PET/CT scan.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.