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

Not Applicable

Completed

• Conditions: Myocardial Remodeling After AMI
• Interventions: Diagnostic Test: 68Ga-FAPI PET/MRI

• Registration Number: NCT04723953
• Lead Sponsor: Ruijin Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-26
• Study First Submitted: 2021-01-22
• Study First Submitted QC: 2021-01-22
• Study First Posted: 2021-01-26
• Status Verified: 2022-03
• Primary Completion: 2022-08-25
• Study Completion: 2022-09-30
• Last Update Submitted: 2022-10-23
• Last Update Posted: 2022-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acute myocardial infarction patient group	68Ga-FAPI PET/MRI	-

Primary Outcome Measures

Name	Time	Method
Infarction size (IS)	Six months after acute myocardial infarction	Percentage of late gadolinum enhancement area in the entire myocardium on MRI
Target-to-background Ratio (TBR)	Six months after acute myocardial infarction	68Ga-FAPI uptake ratio of highly active fibrotic myocardium to heart blood pool on PET images
Ejection fraction (EF)	Six months after acute myocardial infarction	Left ventricular ejection function evaluated on MRI
Metabolic volume (MV)	Six months after acute myocardial infarction	Volume of highly active fibrotic myocardium on PET images

Secondary Outcome Measures

Name	Time	Method
NT-pro-BNP	Six months after acute myocardial infarction	Serum marker of chronic heart failure
hsCRP	Six months after acute myocardial infarction	Serum marker of acute myocardial inflammation

Trial Locations

Locations (1)

Shanghai Ruijin Hospital; 🇨🇳 Shanghai, China