UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043314 |
|---|---|
| Receipt number | R000049447 |
| Scientific Title | Examination of optimal cardiac rest time determination using AI automatic analysis in cardiac MRI and Coronary-MRA (CMRA) imaging method using iNAVI |
| Date of disclosure of the study information | 2021/02/15 |
| Last modified on | 2022/08/16 09:15:18 |
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Basic information
Public title
Examination of optimal cardiac rest time determination using AI automatic analysis in cardiac MRI and Coronary-MRA (CMRA) imaging method using iNAVI
Acronym
Examination of optimal cardiac rest time determination using AI automatic analysis in cardiac MRI and Coronary-MRA (CMRA) imaging method using iNAVI
Scientific Title
Examination of optimal cardiac rest time determination using AI automatic analysis in cardiac MRI and Coronary-MRA (CMRA) imaging method using iNAVI
Scientific Title:Acronym
Examination of optimal cardiac rest time determination using AI automatic analysis in cardiac MRI and Coronary-MRA (CMRA) imaging method using iNAVI
Region
| Japan |
Condition
Condition
Health volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
2D Cine images for automatic analysis using AI and iNAVI-CMRA will be taken for healthy volunteers who have expressed their intention to participate in this study.
The purpose of this study is to determine the optimum imaging conditions by analyzing the obtained data.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
vessel sharpness
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
It is accompanied by a slight invasion of claustrophobic restraint for about 40 minutes.
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy volunteer
Key exclusion criteria
Person who did not obtain research consent.
Persons with internal metal such as pacemakers, tattoos, or arrhythmias
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Suekuni |
Organization
Ehime university hospital
Division name
Department of Radiology
Zip code
7910204
Address
Shitsukawa, Toon, Ehime, Japan
TEL
+81-89-960-5371
suekuni.hiroshi.mj@ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Suekuni |
Organization
Ehime university hospital
Division name
Department of Radiology
Zip code
7910204
Address
Shitsukawa, Toon, Ehime, Japan
TEL
+81-89-960-5371
Homepage URL
suekuni.hiroshi.mj@ehime-u.ac.jp
Sponsor or person
Institute
Ehime University
Institute
Department
Personal name
Funding Source
Organization
Ehime University
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 ,Ehime University Hospital
Address
Shitsukawa, Toon, Ehime
Tel
089-960-5914
rinri@m.ehime-u.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
| 2021 | Year | 02 | Month | 15 | 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
Completed
Date of protocol fixation
| 2021 | Year | 01 | Month | 04 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | 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
| 2021 | Year | 02 | Month | 12 | Day |
Last modified on
| 2022 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049447
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
