Acute Myocardial Infarction (AMI)NCT06841549
the Relationship Between FAPI Results and Myocardial Fibrosis After Acute Myocardial Infarction
An observational study of Acute Myocardial Infarction (AMI), run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial summary
FAPI is a new method to discover the fibrosis of cardiac myocardium in some conditions, like myocardial infarction or cardiomyopathy. This purpose of this study is to find the relationship between FAPI results and myocardial fibrosis through some clinical serum inflammatory factors level. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Myocardial Infarction (AMI)
- What is being tested?
- FAPI
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 3 Dec 2021to 25 Jan 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: acute myocardial infarction after successful primary percutaneous intervention.
Inclusion Criteria: acute myocardial infarction 1) after the successful primary intervention ;2) normal EF value; -
Exclusion Criteria: acute myocardial infarction 1) primary PCI failure; 2) EF reduced; 3) death during the hospitalization;
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Value of FAPI Results in Acute Myocardial Infarction After Successful Coronary Primary Intervention
FAPI is a new method to discover the fibrosis of cardiac myocardium in some conditions, like myocardial infarction or cardiomyopathy. This purpose of this study is to find the relationship between FAPI results and myocardial fibrosis through some clinical serum inflammatory factors level. Meanwhile, it is the first time to provide the prognostic value of FAPI in the progression of acute myocardial infarction.
- Conditions
- Acute Myocardial Infarction (AMI)
- Being tested
- FAPI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAPIOther
FAPI is a new method to find the myocardial fibrosis under some conditions, like myocardial infarction or cardiac myopathy.
| Study group | Role | What they receive |
|---|---|---|
| Echo-AMI | acute myocardial infarction followed by echo | |
| FAPI-AMI | acute myocardial infarction followed by FAPI Receives: Other: FAPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
the target vessel failure, heart failure, repeated angina, arrhythmia and all-cause death.
Measured: the first month, the third month, the half year and the next year 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.
- First posted24 Feb 2025
- Study start3 Dec 2021
- Primary completion20 Jan 2025
- Study completion25 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial Infarction (AMI)Studies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Xiamen UniversityThe 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
- 30 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06841549
- Sponsor's protocol ID
- FirstAHXiamenU-Liang
- Status last verified
- Feb 2025
- First submitted
- 19 Feb 2025
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang M, Quan W, Zhu T, Feng S, Huang X, Meng H, Du R, Zhu Z, Qu X, Li P, Cui Y, Shi K, Yan X, Zhang R, Li B. [68Ga]Ga-DOTA-FAPI-04 PET/MR in patients with acute myocardial infarction: potential role of predicting left ventricular remodeling. Eur J Nucl Med Mol Imaging. 2023 Feb;50(3):839-848. doi: 10.1007/s00259-022-06015-0. Epub 2022 Nov 3.
PubMed 36326870
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of FAPI Results in Acute Myocardial Infarction After Successful Coronary Primary Intervention
- ClinicalTrials.gov ID
- NCT06841549
- Acronym / sponsor ID
- FirstAHXiamenU-Liang
- Conditions
- Acute Myocardial Infarction (AMI)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 3 Dec 2021 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 25 Jan 2025 (actual)
- First posted
- 24 Feb 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.
FAPI is a new method to discover the fibrosis of cardiac myocardium in some conditions, like myocardial infarction or cardiomyopathy. This purpose of this study is to find the relationship between FAPI results and myocardial fibrosis through some clinical serum inflammatory factors level. Meanwhile, it is the first time to provide the prognostic value of FAPI in the progression of acute myocardial infarction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Echo-AMI | – | –acute myocardial infarction followed by echo |
| FAPI-AMI | – | Other: FAPIacute myocardial infarction followed by FAPI |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- acute myocardial infarction after successful primary percutaneous intervention.
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 |
|---|---|---|
| FAPIFAPI is a new method to find the myocardial fibrosis under some conditions, like myocardial infarction or cardiac myopathy. | Other | FAPI-AMI |
Primary outcome
MACE
Time frame: the first month, the third month, the half year and the next year after acute myocardial infarction
the target vessel failure, heart failure, repeated angina, arrhythmia and all-cause death.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Results publication: PubMed 36326870Zhang M, Quan W, Zhu T, Feng S, Huang X, Meng H, Du R, Zhu Z, Qu X, Li P, Cui Y, Shi K, Yan X, Zhang R, Li B. [68Ga]Ga-DOTA-FAPI-04 PET/MR in patients with acute myocardial infarction: potential role of predicting left ventricular remodeling. Eur J Nucl Med Mol Imaging. 2023 Feb;50(3):839-848. doi: 10.1007/s00259-022-06015-0. Epub 2022 Nov 3.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 (AMI), run by The First Affiliated Hospital of Xiamen University 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?
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 24 Feb 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?
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?
MACE (time frame: the first month, the third month, the half year and the next year after acute myocardial infarction). 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 NCT06841549, 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 24 Feb 2025; AzTrials last refreshed its copy on 7 Nov 2026.