UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051723 |
|---|---|
| Receipt number | R000058990 |
| Scientific Title | Investigation of quantitative evaluation of myocardial blood flow using a new semiconductor SPECT/CT |
| Date of disclosure of the study information | 2023/07/26 |
| Last modified on | 2023/07/26 23:04:23 |
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Basic information
Public title
Investigation of quantitative evaluation of myocardial blood flow using a new semiconductor SPECT/CT
Acronym
Investigation of quantitative evaluation of myocardial blood flow using a new semiconductor SPECT/CT
Scientific Title
Investigation of quantitative evaluation of myocardial blood flow using a new semiconductor SPECT/CT
Scientific Title:Acronym
Investigation of quantitative evaluation of myocardial blood flow using a new semiconductor SPECT/CT
Region
| Japan |
Condition
Condition
ischemic heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Myocardial scintigraphy will be performed in patients with suspected ischemic heart disease to establish an examination method (dynamic imaging method) using a new semiconductor SPECT/CT and to examine the possibility of its clinical application. We will also evaluate the image quality of the images taken by the new semiconductor SPECT/CT and the appropriate isotope dosage.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Validity of quantitative values of myocardial blood flow (MBF) and myocardial blood flow reserve (MFR) obtained by dynamic myocardial scintigraphy and diagnostic ability of ischemic heart disease
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Add dynamic imaging to regular myocardial scintigraphy at load and at rest.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Men and women who are 20 years of age or older at the time consent is obtained
2 Patients with written consent from the individual
3 Patients who are eligible for inpatient and outpatient visits
Key exclusion criteria
1 Consumption of food or drink containing caffeine (tea, coffee, etc.) within 24 hours prior to the test
2 Cases in which the use of adenosine is contraindicated
3 Pregnant or possibly pregnant patients
4 Patients who are deemed by the investigator to be unsuitable for participation in this study for any other reason
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Naoto |
| Middle name | |
| Last name | Kawaguchi |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Radiology
Zip code
7910295
Address
Shitsukawa454, Toon, Ehime
TEL
0899645111
n.kawa1113@gmail.com
Public contact
Name of contact person
| 1st name | Naoto |
| Middle name | |
| Last name | Kawaguchi |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Radiology
Zip code
7910295
Address
Shitsukawa454, Toon, Ehime
TEL
0899645111
Homepage URL
n.kawa1113@gmail.com
Sponsor or person
Institute
Ehime University
Institute
Department
Personal name
Funding Source
Organization
None
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
Ehime Uninversity Graduate School of Medicine Department of Radiology
Address
Shitsukawa454, Toon, Shitsukawa
Tel
0899645111
n.kawa1113@gmail.com
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
| 2023 | Year | 07 | Month | 26 | 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
| 2023 | Year | 06 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 26 | Day |
Last modified on
| 2023 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058990
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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