Clinical Trials Logo
  1. Home
  2. Cardiac Output
  3. NCT04941248
  4. Details
NCT04941248 Clinical Trial

Total-body 13N-NH3 PET/CT to Study the Blood Perfusion in Whole Body

Cardiac Output Clinical Trial

Official title:
The Application of Total-body 13N-NH3 PET/CT to Study the Blood Perfusion System in the Whole Body

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04941248
Other study ID # KY2021-086
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 27, 2021
Est. completion date December 8, 2024

Study information
Verified date May 2024
Source RenJi Hospital
Contact Yumei Chen, Ph.D; M.D.
Phone 86-021-58752345
Email cymrenji@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 caused by the decreased cardiac function.

Description:

Participants are invited to participate in a research that seeks to understand the dynamic blood perfusion in human body. The investigators expect to have twenty-five participants in this study at Renji Hospital, Shanghai. About sixteen of the participants will be patients who have been diagnosed with decreased cardiac function, nine participants will be healthy individuals with no known vascular disease. These healthy subjects will allow researchers to compare blood perfusion difference with those of persons with decreased cardiac function. 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 25
Est. completion date December 8, 2024
Est. primary completion date June 8, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 90 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
China Shanghai jiaotong University School of Medicine, Renji Hospital Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 4 years
See also
  Status Clinical Trial Phase
Recruiting NCT04604886 - The Consistency of Cardiac Output Measured by Pulmonary Artery Catheter and LiDCO in Cardiac Surgical Patients N/A
Completed NCT04044157 - Cardiac Output in Children During Anesthesia
Not yet recruiting NCT01678066 - A Prospective Study to Bilaterally Compare a Non-Invasive Cardiac Output Monitor N/A
Completed NCT01001533 - Assess the Ability of Electrical Cardiometry to Trend Hemodynamic Variables During Dexmedetomidine Sedation N/A
Recruiting NCT04926220 - Dynamic Estimation of Cardiac Output in the Operating Room
Not yet recruiting NCT06007196 - Evaluation of Non-invasive Continuous Hemodynamic Measurement From Task Force CORE
Recruiting NCT05648279 - Personalized Hemodynamic Management in High-risk Major Abdominal Surgery N/A
Recruiting NCT06090396 - Non-invasive Cardiac Index in Children
Completed NCT05508711 - Comparability of Transesophageal Echocardiography and FloTrac/Vigileo System Three Different Positions
Completed NCT02438228 - Cardiac Output by Nine Different Pulse Contour Algorithms N/A
Completed NCT00996190 - Best Regimen for Phenylephrine Administration During Cesarean Section Phase 4
Withdrawn NCT00783679 - The Feasibility and Accuracy of Exhaled CO2 to Measure Cardiac Output in Ventilated Patients Without Tracheal Intubation N/A
Active, not recruiting NCT04465201 - The Smart Pump Study N/A
Completed NCT05779683 - Caretaker in the Cardiovascular Intensive Care Unit (CVICU)
Completed NCT04112719 - Assessing Effects of Lateral Tilt on Cardiac Output Using a Non-invasive Technique
Recruiting NCT01781260 - Effect of Prone Position on Liver Blood Flow and Function N/A
Recruiting NCT02156856 - Stroke Volume Analysis During Aortic Valve Replacement Trial N/A
Terminated NCT00920569 - Recirculation, Oxygenator Blood Volume and Cardiac Output Measurements During Extracorporeal Membrane Oxygenation N/A
Recruiting NCT06114147 - Cardiac Flow Measurements in Pregnant Women by Non Invasive Techniques N/A
Completed NCT05365113 - Comparison of Hemodynamic Effects of Two Modalities of Alveolar Recruitment Maneuvers in Major Abdominal Surgery Patients N/A