Cardiac OutputNCT04941248

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

An observational study of Cardiac Output, run by RenJi Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 60 to 90 yearsHealthy volunteers can take part
Conditions the study is for: Cardiac Output
What is being tested?: total-body PET/CT(uEXPLORER , United Imaging Healthcare, China)
Type of treatment: Medical device
How many people: 34 participants
Where: 1 siteChina
Study dates: 27 Jun 2021to 8 Feb 2026
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 to 90 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Individuals aged between 60 and 90 years old with severe AS condition will be eligible for our enrollment; and participants without any history of vascular disease will be eligible.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai jiaotong University School of Medicine, Renji Hospital
Shanghai, Shanghai Municipality, 200127

Other trials in China

About this study

Official 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

Read the 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
Being tested: total-body PET/CT(uEXPLORER , United Imaging Healthcare, China)
Keywords: Total-body; PET/CT; N-13 ammonia; Blood perfusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT04941248
Study group	Role	What they receive
Healthy controls		All healthy subjects will undergo the following intervention: 13N-NH3 PET/CT scan on the total-body uEXPLORER scanner. Receives: Device: total-body PET/CT(uEXPLORER , United Imaging Healthcare, China)
Patients with cardiac disfunction		All patients will undergo the following intervention: 13N-NH3 PET/CT scan on the total-body uEXPLORER scanner. Receives: Device: total-body PET/CT(uEXPLORER , United Imaging Healthcare, China)

What is being measured

The primary outcome is the main question the study is designed to answer.

Evaluation of Multi-Organ Blood Perfusion by Total Body Dynamic uEXPLORER PET/CT Scan
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.
Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Jun 20218 Feb 2026

First posted28 Jun 2021
Study start27 Jun 2021
Primary completion8 Jan 2026
Study completion8 Feb 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Cardiac OutputStudies of the same condition, open and under way.
More trials run by RenJi HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04941248
Sponsor's protocol ID: KY2021-086
Status last verified: Apr 2025
First submitted: 15 Jun 2021
Last updated: 17 Mar 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Benz DC, Ferro P, Safa N, Messerli M, von Felten E, Huang W, Patriki D, Giannopoulos AA, Fuchs TA, Grani C, Gebhard C, Pazhenkottil AP, Kaufmann PA, Buechel RR. Role of quantitative myocardial blood flow and 13N-ammonia washout for viability assessment in ischemic cardiomyopathy. J Nucl Cardiol. 2021 Feb;28(1):263-273. doi: 10.1007/s12350-019-01684-1. Epub 2019 Mar 20.
PubMed 30895563
Lang JK, Canty JM Jr. The complexity of using resting myocardial perfusion to assess myocardial viability and predict functional recovery. J Nucl Cardiol. 2021 Feb;28(1):274-277. doi: 10.1007/s12350-019-01742-8. Epub 2019 May 13. No abstract available.
PubMed 31087267
Kang KW, Kim JS, Cho SG, Kim J, Song HC. Acquisition of dynamic N-13 ammonia PET for myocardial blood flow quantification. J Nucl Cardiol. 2020 Aug;27(4):1288-1292. doi: 10.1007/s12350-020-02062-y. Epub 2020 Feb 19. No abstract available.
PubMed 32076961
Giubbini R, Peli A, Milan E, Sciagra R, Camoni L, Albano D, Bertoli M, Bonacina M, Motta F, Statuto M, Rodella CA, De Agostini A, Calabretta R, Bertagna F; Italian Nuclear Cardiology Group (GICN). Comparison between the summed difference score and myocardial blood flow measured by 13N-ammonia. J Nucl Cardiol. 2018 Oct;25(5):1621-1628. doi: 10.1007/s12350-017-0789-z. Epub 2017 Feb 3.
PubMed 28160262
Sciagra R, Lubberink M, Hyafil F, Saraste A, Slart RHJA, Agostini D, Nappi C, Georgoulias P, Bucerius J, Rischpler C, Verberne HJ; Cardiovascular Committee of the European Association of Nuclear Medicine (EANM). EANM procedural guidelines for PET/CT quantitative myocardial perfusion imaging. Eur J Nucl Med Mol Imaging. 2021 Apr;48(4):1040-1069. doi: 10.1007/s00259-020-05046-9. Epub 2020 Nov 2.
PubMed 33135093
Lammertsma AA. Forward to the Past: The Case for Quantitative PET Imaging. J Nucl Med. 2017 Jul;58(7):1019-1024. doi: 10.2967/jnumed.116.188029. Epub 2017 May 18.
PubMed 28522743
Akamatsu G, Uba K, Taniguchi T, Mitsumoto K, Narisue A, Tsutsui Y, Sasaki M. Impact of Time-of-Flight PET/CT with a Large Axial Field of View for Reducing Whole-Body Acquisition Time. J Nucl Med Technol. 2014 Jun;42(2):101-4. doi: 10.2967/jnmt.114.140665. Epub 2014 May 5.
PubMed 24799607
Zhang X, Cherry SR, Xie Z, Shi H, Badawi RD, Qi J. Subsecond total-body imaging using ultrasensitive positron emission tomography. Proc Natl Acad Sci U S A. 2020 Feb 4;117(5):2265-2267. doi: 10.1073/pnas.1917379117. Epub 2020 Jan 21.
PubMed 31964808
Zhang X, Xie Z, Berg E, Judenhofer MS, Liu W, Xu T, Ding Y, Lv Y, Dong Y, Deng Z, Tang S, Shi H, Hu P, Chen S, Bao J, Li H, Zhou J, Wang G, Cherry SR, Badawi RD, Qi J. Total-Body Dynamic Reconstruction and Parametric Imaging on the uEXPLORER. J Nucl Med. 2020 Feb;61(2):285-291. doi: 10.2967/jnumed.119.230565. Epub 2019 Jul 13.
PubMed 31302637
Cherry SR, Jones T, Karp JS, Qi J, Moses WW, Badawi RD. Total-Body PET: Maximizing Sensitivity to Create New Opportunities for Clinical Research and Patient Care. J Nucl Med. 2018 Jan;59(1):3-12. doi: 10.2967/jnumed.116.184028. Epub 2017 Sep 21.
PubMed 28935835

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Comparison of PPV and LVOT VTI During Passive Leg Raising to Predict Fluid Responsiveness
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UltraTrac for Cardiac Output Monitoring in Congenital Heart Disease
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Active, not recruitingObservational study
Post-Induction Low Cardiac Output Syndrome in Coronary Artery Bypass Graft Surgery
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Not yet recruiting
Bedside Assessment of Right Ventricular Output Lying in Prone Or Supine
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All Cardiac Output trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT04941248
Acronym / sponsor ID: KY2021-086
Conditions: Cardiac Output
Keywords: Total-body; PET/CT; N-13 ammonia; Blood perfusion
Study type: Observational
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: RenJi HospitalUniversity, hospital or other
Study start: 27 Jun 2021 (actual)
Primary completion: 8 Jan 2026 (actual)
Study completion: 8 Feb 2026 (actual)
First posted: 28 Jun 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Healthy controls	–	Device: total-body PET/CT(uEXPLORER , United Imaging Healthcare, China)All healthy subjects will undergo the following intervention: 13N-NH3 PET/CT scan on the total-body uEXPLORER scanner.
Patients with cardiac disfunction	–	Device: total-body PET/CT(uEXPLORER , United Imaging Healthcare, China)All patients will undergo the following intervention: 13N-NH3 PET/CT scan on the total-body uEXPLORER scanner.

Who may qualify

Ages: 60 to 90 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Individuals aged between 60 and 90 years old with severe AS condition will be eligible for our enrollment; and participants without any history of vascular disease will be eligible.

Key inclusion criteria (4 listed)

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

Key exclusion criteria (6 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Device	Healthy controls, Patients with cardiac disfunction

Primary outcome

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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
Background: PubMed 30895563Benz DC, Ferro P, Safa N, Messerli M, von Felten E, Huang W, Patriki D, Giannopoulos AA, Fuchs TA, Grani C, Gebhard C, Pazhenkottil AP, Kaufmann PA, Buechel RR. Role of quantitative myocardial blood flow and 13N-ammonia washout for viability assessment in ischemic cardiomyopathy. J Nucl Cardiol. 2021 Feb;28(1):263-273. doi: 10.1007/s12350-019-01684-1. Epub 2019 Mar 20.
Background: PubMed 31087267Lang JK, Canty JM Jr. The complexity of using resting myocardial perfusion to assess myocardial viability and predict functional recovery. J Nucl Cardiol. 2021 Feb;28(1):274-277. doi: 10.1007/s12350-019-01742-8. Epub 2019 May 13. No abstract available.
Background: PubMed 32076961Kang KW, Kim JS, Cho SG, Kim J, Song HC. Acquisition of dynamic N-13 ammonia PET for myocardial blood flow quantification. J Nucl Cardiol. 2020 Aug;27(4):1288-1292. doi: 10.1007/s12350-020-02062-y. Epub 2020 Feb 19. No abstract available.
Background: PubMed 28160262Giubbini R, Peli A, Milan E, Sciagra R, Camoni L, Albano D, Bertoli M, Bonacina M, Motta F, Statuto M, Rodella CA, De Agostini A, Calabretta R, Bertagna F; Italian Nuclear Cardiology Group (GICN). Comparison between the summed difference score and myocardial blood flow measured by 13N-ammonia. J Nucl Cardiol. 2018 Oct;25(5):1621-1628. doi: 10.1007/s12350-017-0789-z. Epub 2017 Feb 3.
Background: PubMed 33135093Sciagra R, Lubberink M, Hyafil F, Saraste A, Slart RHJA, Agostini D, Nappi C, Georgoulias P, Bucerius J, Rischpler C, Verberne HJ; Cardiovascular Committee of the European Association of Nuclear Medicine (EANM). EANM procedural guidelines for PET/CT quantitative myocardial perfusion imaging. Eur J Nucl Med Mol Imaging. 2021 Apr;48(4):1040-1069. doi: 10.1007/s00259-020-05046-9. Epub 2020 Nov 2.
Background: PubMed 28522743Lammertsma AA. Forward to the Past: The Case for Quantitative PET Imaging. J Nucl Med. 2017 Jul;58(7):1019-1024. doi: 10.2967/jnumed.116.188029. Epub 2017 May 18.
Background: PubMed 24799607Akamatsu G, Uba K, Taniguchi T, Mitsumoto K, Narisue A, Tsutsui Y, Sasaki M. Impact of Time-of-Flight PET/CT with a Large Axial Field of View for Reducing Whole-Body Acquisition Time. J Nucl Med Technol. 2014 Jun;42(2):101-4. doi: 10.2967/jnmt.114.140665. Epub 2014 May 5.
Background: PubMed 31964808Zhang X, Cherry SR, Xie Z, Shi H, Badawi RD, Qi J. Subsecond total-body imaging using ultrasensitive positron emission tomography. Proc Natl Acad Sci U S A. 2020 Feb 4;117(5):2265-2267. doi: 10.1073/pnas.1917379117. Epub 2020 Jan 21.
Background: PubMed 31302637Zhang X, Xie Z, Berg E, Judenhofer MS, Liu W, Xu T, Ding Y, Lv Y, Dong Y, Deng Z, Tang S, Shi H, Hu P, Chen S, Bao J, Li H, Zhou J, Wang G, Cherry SR, Badawi RD, Qi J. Total-Body Dynamic Reconstruction and Parametric Imaging on the uEXPLORER. J Nucl Med. 2020 Feb;61(2):285-291. doi: 10.2967/jnumed.119.230565. Epub 2019 Jul 13.
Background: PubMed 28935835Cherry SR, Jones T, Karp JS, Qi J, Moses WW, Badawi RD. Total-Body PET: Maximizing Sensitivity to Create New Opportunities for Clinical Research and Patient Care. J Nucl Med. 2018 Jan;59(1):3-12. doi: 10.2967/jnumed.116.184028. Epub 2017 Sep 21.
Individual participant dataSharing planned: No

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Not yet recruitingObservational study
Ultrasound-Calibrated Pulse Contour Cardiac Output Monitoring: Value and Accuracy in Hemodynamic Care
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Comparison of PPV and LVOT VTI During Passive Leg Raising to Predict Fluid Responsiveness
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Not yet recruiting
UltraTrac for Cardiac Output Monitoring in Congenital Heart Disease
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yumei Chen, Ph.D; M.D. principal investigator

RenJi Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiac Output, run by RenJi Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of Multi-Organ Blood Perfusion by Total Body Dynamic uEXPLORER PET/CT Scan (time frame: 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04941248, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.