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Completed

NCT Number: NCT04941248

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

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.

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Key information

Conditions

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai jiaotong University School of Medicine, Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Nine healthy volunteers with normal EF values
  • Patients with decreased cardiac function, while their heart function grading above II(New York Heart Association,NYHA)
  • Aged 60~90 years old
  • Written informed consents will be offered and signed by all participants

Exclusion criteria

  • History of vascular-related diseases in other organs
  • Severe liver and kidney dysfunctions
  • Patients who are pregnant or breast feeding
  • People under the age of 60 years old
  • Heart function grading below II(NYHA)
  • inability to lie or to maintain posture in the scanner for one hour

Treatment and study plan

total-body PET/CT(uEXPLORER , United Imaging Healthcare, China)

Device

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.

Primary outcomes

  1. Evaluation of Multi-Organ Blood Perfusion by Total Body Dynamic uEXPLORER PET/CT Scan

    Time frame: 4 years

    The total-body 13N-NH3 PET/CT will be adopted to evaluate the blood flow differences in whole body between healthy controls and patients with decreased cardiac function.

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jun 28, 2021
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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