Clinical trial NCT04723953: Cardiac Fibroblast Activation Detected by 68Ga-FAPI PET/MR
Official title: Cardiac Fibroblast Activation Detected by 68Ga-FAPI PET/MR is a Prognostic Indicator in Patients With Myocardial Infarction.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Remodeling After AMI
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Target-to-background Ratio (TBR)
timeFrame: One week after acute myocardial infarction
measure: Metabolic volume (MV)
timeFrame: One week after acute myocardial infarction
measure: Infarction size (IS)
timeFrame: One week after acute myocardial infarction
measure: Ejection fraction (EF)
timeFrame: One week after acute myocardial infarction
measure: Target-to-background Ratio (TBR)
timeFrame: Six months after acute myocardial infarction
measure: Metabolic volume (MV)
timeFrame: Six months after acute myocardial infarction
measure: Infarction size (IS)
timeFrame: Six months after acute myocardial infarction
measure: Ejection fraction (EF)
timeFrame: Six months after acute myocardial infarction
Secondary outcomes:
measure: NT-pro-BNP
timeFrame: One week after acute myocardial infarction
measure: hsCRP
timeFrame: One week after acute myocardial infarction
measure: NT-pro-BNP
timeFrame: Six months after acute myocardial infarction
measure: hsCRP
timeFrame: Six months after acute myocardial infarction
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ruijin Hospital
Study officials:
References: