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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04941248
Enrollment
34
Registered
2021-06-28
Start date
2021-06-27
Completion date
2026-02-08
Last updated
2026-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Output

Keywords

Total-body; PET/CT; N-13 ammonia; Blood perfusion

Brief 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.

Interventions

DEVICEtotal-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.

Sponsors

RenJi Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to 90 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of Multi-Organ Blood Perfusion by Total Body Dynamic uEXPLORER PET/CT Scan4 yearsThe 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.

Countries

China

Contacts

PRINCIPAL_INVESTIGATORYumei Chen, Ph.D; M.D.

RenJi Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026