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

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Remodeling After AMI
• Intervention / Treatment: Diagnostic test: 68Ga-FAPI PET/MRI

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200025
    • Shanghai Ruijin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Acute myocardial infarction patient group	Diagnostic test: 68Ga-FAPI PET/MRI; PET and MRI in patients with acute myocardiac infarction are simultaneously analyzed using hybrid PET/MRI device for monitoring myocardial fibrosis and function.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NT-pro-BNP	Serum marker of chronic heart failure	One week after acute myocardial infarction
hsCRP	Serum marker of acute myocardial inflammation	One week after acute myocardial infarction
NT-pro-BNP	Serum marker of chronic heart failure	Six months after acute myocardial infarction
hsCRP	Serum marker of acute myocardial inflammation	Six months after acute myocardial infarction

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 26, 2020
• Primary Completion (ACTUAL): August 25, 2022
• Study Completion (ACTUAL): September 30, 2022

Study Registration Dates

• First Submitted: January 22, 2021
• First Submitted That Met QC Criteria: January 22, 2021
• First Posted (ACTUAL): January 26, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 25, 2022
• Last Update Submitted That Met QC Criteria: October 23, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: (2020)CER(152)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No