NCT04941248

Total-body 13N-NH3 PET/CT to Study the Blood Perfusion in Severe AS Patients Pre- and Post-TAVR in Whole Body

The Application of Total-body 13N-NH3 PET/CT to Study the Blood Perfusion System in Severe AS Patients Before and After TAVR Surgery in the Whole Body

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 34 (actual)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 60 Years – 90 Years
• Healthy volunteers: Accepted

Summary

The aim of our study is to analyze and quantitate whole-body blood perfusion by total-body 13N-NH3 PET/CT(uEXPLORER), and evaluate the influence to other organs in severe AS patients and the impact of TAVR surgery.

Detailed description

Participants are invited to participate in a research that seeks to understand the dynamic blood perfusion in severe AS patients in human body. The investigators expect to have twenty-five participants in this study at Renji Hospital, Shanghai. Nine participants will be healthy individuals with no known vascular disease. All the participants will undergo the same procedure. If participants agree to participate in this study, researchers will first interview participants and review the past medical record in order to document the medical history. When the screening procedures confirm that participants are eligible to participate in the study, participants will receive one dose of the non-therapeutic administration of a radioactive tracer called N-13 ammonia(13NH3) , then undergo one total body 13NH3 PET/CT Scan (uEXPLORER) to determine the blood flow value of the brain, kidney and other organs. The total body 13NH3 PET/CT Scan will allow investigators to observe and analyze the real-time blood flow differences between patients with between healthy controls and decreased cardiac function.

Conditions

• Cardiac Output

Interventions

Type	Name	Description
DEVICE	total-body PET/CT(uEXPLORER , United Imaging Healthcare, China)	This prospective study will enroll twenty-five patients, including nine healthy volunteers, sixteen patients with decreased cardiac function . All of them will have a whole-body PET/CT(uEXPLORER , United Imaging Healthcare, China) in our department, Renji Hospital.

Timeline

• Start date: 2021-06-27
• Primary completion: 2026-01-08
• Completion: 2026-02-08
• First posted: 2021-06-28
• Last updated: 2026-03-17

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated device study