AzTrials
AzTrials

Myocardial Remodeling After AMINCT04723953

Cardiac Fibroblast Activation Detected by 68Ga-FAPI PET/MR

A study testing 68Ga-FAPI PET/MRI in people with Myocardial Remodeling After AMI, run by Ruijin Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Myocardial infarction is the most common cause of high mortality in the modern world. The short-term survival rate of ST-elevated myocardial infarction (STEMI) has been dramatically increased in the past decades thanks to primary coronary intervention and standardization of treatment. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Myocardial Remodeling After AMI
What is being tested?
68Ga-FAPI PET/MRI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
89 participants
Where
1 siteChina
Study dates
26 Aug 2020to 30 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • between 18-75 years old
  • diagnosed with coronary angiography
  • performed percutaneous coronary intervention，with successful myocardial reperfusion

Who cannot join

  • unstable hemodynamics
  • MR contraindications (such as pacemaker or nerve stimulator or metal foreign body, high fever, severe renal failure, etc.)
  • Claustrophobia

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Ruijin Hospital

    Shanghai, 200025

Other trials in China

About this study

Official title: Cardiac Fibroblast Activation Detected by 68Ga-FAPI PET/MR is a Prognostic Indicator in Patients With Myocardial Infarction.

Myocardial infarction is the most common cause of high mortality in the modern world. The short-term survival rate of ST-elevated myocardial infarction (STEMI) has been dramatically increased in the past decades thanks to primary coronary intervention and standardization of treatment. However, the long-term prognosis of patients with acute myocardial infarction (AMI) is still poor, especially in the aging population, due to heart failure related to inappropriate myocardial fibrosis and subsequent left ventricular (LV) remodeling. Despite the amelioration of STEMI management, LV remodeling still occurs in approximately 1/3 of all STEMI patients. Therefore, early identification of such patients may help the optimization of therapy and eventually the outcomes.

One characteristic of activated cardiac fibroblasts is the expression of FAP (fibroblast activation protein). A tracer (FAP inhibitor) for positron emission tomography that targets FAP has been used to measure relative FAP density indicative of activated fibroblasts in different cancer entities. However, whether it can reliably assess myocardial fibrosis and predict the poor prognosis caused by LV remodeling is not yet known. Therefore, We aim to observe active myocardial fibrosis process in patients with AMI, and analyze its relationship with the patients'prognosis in a longitudinal study through 68Ga-FAPI PET/MRI.

Being tested
68Ga-FAPI PET/MRI

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 68Ga-FAPI PET/MRIDiagnostic test

    PET and MRI in patients with acute myocardiac infarction are simultaneously analyzed using hybrid PET/MRI device for monitoring myocardial fibrosis and function.

Study groups in NCT04723953
Study groupRoleWhat they receive
Acute myocardial infarction patient groupExperimentalNot described
Receives: Diagnostic Test: 68Ga-FAPI PET/MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Target-to-background Ratio (TBR)

    68Ga-FAPI uptake ratio of highly active fibrotic myocardium to heart blood pool on PET images

    Measured: One week after acute myocardial infarction

  2. Metabolic volume (MV)

    Volume of highly active fibrotic myocardium on PET images

    Measured: One week after acute myocardial infarction

  3. Infarction size (IS)

    Percentage of late gadolinum enhancement area in the entire myocardium on MRI

    Measured: One week after acute myocardial infarction

  4. Ejection fraction (EF)

    Left ventricular ejection function evaluated on MRI

    Measured: One week after acute myocardial infarction

  5. Target-to-background Ratio (TBR)

    68Ga-FAPI uptake ratio of highly active fibrotic myocardium to heart blood pool on PET images

    Measured: Six months after acute myocardial infarction

  6. Metabolic volume (MV)

    Volume of highly active fibrotic myocardium on PET images

    Measured: Six months after acute myocardial infarction

  7. Infarction size (IS)

    Percentage of late gadolinum enhancement area in the entire myocardium on MRI

    Measured: Six months after acute myocardial infarction

  8. Ejection fraction (EF)

    Left ventricular ejection function evaluated on MRI

    Measured: Six months after acute myocardial infarction

Secondary outcomes (4)

  1. NT-pro-BNP

    Serum marker of chronic heart failure

    Measured: One week after acute myocardial infarction

  2. hsCRP

    Serum marker of acute myocardial inflammation

    Measured: One week after acute myocardial infarction

  3. NT-pro-BNP

    Serum marker of chronic heart failure

    Measured: Six months after acute myocardial infarction

  4. hsCRP

    Serum marker of acute myocardial inflammation

    Measured: Six months after acute myocardial infarction

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2021
  2. Study start26 Aug 2020
  3. Primary completion25 Aug 2022
  4. Study completion30 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
89 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04723953
Sponsor's protocol ID
(2020)CER(152)
Status last verified
Mar 2022
First submitted
22 Jan 2021
Last updated
25 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Qiao X, Wang H, Meng H, Xi Y, Feng DD, Li B, Yan X, Zhang M, Huang Q. Multi-modality deep learning-based [68Ga]Ga-DOTA-FAPI-04 PET polar map generation: potential value in detecting reactive fibrosis after myocardial infarction. Eur J Nucl Med Mol Imaging. 2024 Nov;51(13):3944-3959. doi: 10.1007/s00259-024-06850-3. Epub 2024 Jul 26.

    PubMed 39060373

Questions about this trial

What is this clinical trial studying?

A study testing 68Ga-FAPI PET/MRI in people with Myocardial Remodeling After AMI, run by Ruijin 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 3 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: finished, as of the sponsor's last update on 25 Oct 2022. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target-to-background Ratio (TBR) (time frame: One week after acute myocardial infarction). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04723953, which also lists 1 linked publication.

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 25 Oct 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in