UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058545 |
|---|---|
| Receipt number | R000066451 |
| Scientific Title | Evaluation of the effectiveness of cardiac cine MRI examinations using a combination of deep learning and compressed sensing |
| Date of disclosure of the study information | 2025/07/22 |
| Last modified on | 2025/07/22 14:57:38 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of the effectiveness of cardiac cine MRI examinations using compressed sensing and AI
Acronym
Evaluation of the effectiveness of cardiac cine MRI examinations using CS and AI
Scientific Title
Evaluation of the effectiveness of cardiac cine MRI examinations using a combination of deep learning and compressed sensing
Scientific Title:Acronym
Evaluation of the effectiveness of cardiac cine MRI examinations using AI and CS
Region
| Japan |
Condition
Condition
heart disease
Classification by specialty
| Cardiology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Cardiac MRI is a useful examination that allows for a comprehensive evaluation of myocardial damage, myocardial contractility, myocardial blood flow, coronary artery stenosis, and hemodynamics without radiation exposure. Cine MRI is a method that synchronizes with an electrocardiogram to capture images of cardiac motion in a video-like manner, enabling quantitative and qualitative evaluation of cardiac function without the use of contrast agents. Compressed sensing (CS) is a technology that restores accurate images from a small amount of sampling data and is applied to cardiac MRI examinations. Setting a high acceleration factor (AF) in CS reduces duration time but degrades image quality. The newly introduced technology which combines CS with image reconstruction using deep learning (DL) enable to acquire high quality images. This technology is expected to reduce examination time while maintaining good image quality. The aim of this study is to assess the image quality and duration time using both this technology and conventional method.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Image quality evaluation
Key secondary outcomes
inspection time
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Multiple acceleration factors (AF = 2, 5, 10, 15, etc.) are set for CS, and cine MRI is imaged using both the conventional method (cine MRI without DL) and cine MRI with DL. Images of the left ventricular short-axis view from the base to the apex of the heart are collected. The examination time is expected to be approximately 30 minutes. Image data will be transferred to a dedicated workstation for analysis of quantitative parameters used in image quality assessment and cardiac function analysis. These quantitative parameters, subjective image quality evaluations, and imaging time will be compared and contrasted with the conventional method.
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) Healthy volunteers aged 20 years or older with no history of heart disease
2) persons who have been informed about the research in advance and have given their consent
Key exclusion criteria
1) persons who could not give research consent
2) claustrophobic person
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Sho |
| Middle name | |
| Last name | Akasaka |
Organization
Ehime University Hospital
Division name
radiology
Zip code
791-0295
Address
454 Shitsukawa, Toon, Ehime, Japan
TEL
089-960-5371
akasaka.sho.xg@ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Akasaka |
Organization
Ehime University Hospital
Division name
radiology
Zip code
791-0295
Address
454 Shitsukawa, Toon, Ehime, Japan
TEL
089-960-5371
Homepage URL
akasaka.sho.xg@ehime-u.ac.jp
Sponsor or person
Institute
Ehime University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
Address 454 Shitsukawa, Toon, Ehime
Tel
089-960-5172
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
| 2025 | Year | 07 | Month | 22 | 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 | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 22 | Day |
Last modified on
| 2025 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066451
