UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059360 |
|---|---|
| Receipt number | R000067891 |
| Scientific Title | A Prospective Observational Study Comparing Coronary Blood Flow and Microcirculation Assessment Between Photon-Counting CT and N-13 Ammonia PET |
| Date of disclosure of the study information | 2025/10/14 |
| Last modified on | 2025/10/09 22:09:33 |
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Basic information
Public title
A Prospective Observational Study Comparing Coronary Blood Flow and Microcirculation Assessment Between Photon-Counting CT and N-13 Ammonia PET
Acronym
Study on evaluating heart blood flow and microcirculation using photon-counting CT and PET
Scientific Title
A Prospective Observational Study Comparing Coronary Blood Flow and Microcirculation Assessment Between Photon-Counting CT and N-13 Ammonia PET
Scientific Title:Acronym
Comparison of coronary blood flow and microcirculation assessment between photon-counting CT and N-13 ammonia PET
Region
| Japan |
Condition
Condition
Symptomatic Stable Angina Pectoris
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to prospectively evaluate the degree of agreement between coronary flow reserve (CFR) calculated using photon-counting CT (PCCT) and those obtained by N-13 ammonia PET in patients with symptomatic stable angina pectoris.
Basic objectives2
Others
Basic objectives -Others
Evaluation of diagnostic validity and agreement of photon-counting CT-derived coronary flow reserve compared with N-13 ammonia PET.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Pearson correlation coefficient and Bland-Altman agreement between coronary flow reserve (CFR) values derived from photon-counting CT and those obtained by N-13 ammonia PET.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients clinically diagnosed with symptomatic stable angina pectoris
Aged 20 years or older and under 85 years at the time of obtaining informed consent
Physically suitable for both cardiac CT and PET examinations, and able to undergo pharmacologic stress testing (e.g., adenosine)
Provided written informed consent after receiving adequate explanation of the study
Key exclusion criteria
Patients with obesity that may cause technical difficulty or significant image degradation (e.g., BMI > 35)
Patients with significant arrhythmias (e.g., frequent premature beats or atrial fibrillation) that preclude stable ECG gating, as judged by the investigator
Pregnant or breastfeeding women
Patients with severe renal dysfunction (eGFR < 30 mL/min/1.73m2)
Patients with severe hepatic dysfunction (equivalent to Child-Pugh class C)
Patients with a history of severe allergy to iodinated contrast agents or pharmacologic stress agents (e.g., adenosine)
Patients with clinically significant comorbidities (e.g., acute heart failure) that make participation unsafe
Patients deemed inappropriate for participation by the principal investigator or sub-investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Hoshino |
Organization
Institute of Science Tokyo Hospital
Division name
Department of cardiology
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-6111
mnksr0514@gmail.com
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Hoshino |
Organization
Institute of Science Tokyo Hospital
Division name
Department of cardiology
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-6111
Homepage URL
hoshino.masahiro@tmd.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
Institute of Science Tokyo
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Institute of Science Tokyo Hospital
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel
+81-3-5803-5231
hoshino.masahiro@tmd.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a single-arm prospective observational study conducted at the Institute of Science Tokyo Hospital in collaboration with Tokyo Women's Medical University.
The results will be disseminated through the UMIN-CTR registry, academic conferences, and peer-reviewed journals.
Management information
Registered date
| 2025 | Year | 10 | Month | 09 | Day |
Last modified on
| 2025 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067891
