UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058653 |
|---|---|
| Receipt number | R000067071 |
| Scientific Title | Prospective Observational Study on Free-Breathing Cardiac Cine MRI Using a Deep Learning Super-Resolution Engine |
| Date of disclosure of the study information | 2025/07/31 |
| Last modified on | 2025/07/31 12:56:57 |
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Basic information
Public title
Validation of Free-Breathing Cardiac Cine: A single-center prospective study
Acronym
Free-breath Cardiac Cine Validation Study
Scientific Title
Prospective Observational Study on Free-Breathing Cardiac Cine MRI Using a Deep Learning Super-Resolution Engine
Scientific Title:Acronym
PRECISE-DL Study
Region
| Japan |
Condition
Condition
Patients requiring cardiac MRI due to ischemic heart disease, cardiomyopathy, valvular heart disease, congenital heart disease, etc.
Classification by specialty
| Cardiology | Radiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this prospective observational study is to assess the clinical validity of a novel free-breathing cardiac cine MRI technique by comparing left ventricular ejection fraction (LVEF) measurements obtained with the conventional breath-hold cine against those acquired with the free-breathing cine in patients clinically indicated for cardiac MRI at Tohoku University Hospital. The primary endpoint is the difference in LVEF between the two methods.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference in left ventricular ejection fraction (LVEF) obtained by conventional breath-hold cardiac cine MRI versus free-breathing cardiac cine MRI.
Key secondary outcomes
1. Differences in cardiac volumetric and functional parameters
- Left ventricular end-diastolic volume (LVEDV), left ventricular end-systolic volume (LVESV), left ventricular cardiac output, left ventricular myocardial mass, right ventricular end-diastolic volume (RVEDV), right ventricular end-systolic volume (RVESV), right ventricular cardiac output, left atrial maximum volume, left atrial minimum volume, right atrial maximum volume, and right atrial minimum volume obtained by conventional breath-hold versus free-breathing cine MRI.
2. Differences in myocardial deformation metrics
- Myocardial strain and strain rate measured with conventional breath-hold versus free-breathing cine MRI.
3. Difference in qualitative image quality
- Difference in the proportion of cine images rated as Grade 3 or higher on qualitative image quality scoring between the two methods.
4. Differences in quantitative image quality metrics
- Difference in quantitative measures of image quality (e.g., signal-to-noise ratio, contrast-to-noise ratio) between conventional breath-hold and free-breathing cine MRI.
5. Difference in acquisition time
- Difference in total cine image acquisition time between the two techniques.
6. Interobserver agreement
- Interobserver agreement (e.g., Cohen's kappa) for qualitative image quality grading.
7. Subgroup analysis of the primary outcome
- Analysis of the primary outcome (difference in LVEF) in patient subgroups stratified by age, sex, body mass index (BMI), respiratory rate, heart rate, and presence/absence of arrhythmia.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients clinically indicated for cardiac MRI.
2. Age 18 years or older and under 90 years.
3. Subjects who have provided written informed consent for participation in the study.
Key exclusion criteria
1. Patients with contraindications to MRI.
2. Patients with implanted pacemakers or implantable cardioverter-defibrillators (ICDs).
3. Pregnant or potentially pregnant women.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Ota |
Organization
Tohoku University Hospital
Division name
Radiology
Zip code
9808574
Address
1-1, Seiryo, Aoba, Sendai, Miyagi
TEL
0227177312
hideki.ota.d6@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Hidenobu |
| Middle name | |
| Last name | Takagi |
Organization
Tohoku University Graduate School of Medicine
Division name
Advanced Radiological Imaging Collaborative Research
Zip code
9800872
Address
2-1, Seiryo, Aoba, Sendai, Miyagi
TEL
0227177312
Homepage URL
hidenobu.takagi.b8@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Canon Medical Systems
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Graduate School of Medicine, Tohoku University
Address
2-1, Seiryo, Aoba, Sendai, Miyagi
Tel
022-728-4105
ec-med@grp.tohoku.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
宮城県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 06 | Month | 05 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 02 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
IRB #2025-1-299
Management information
Registered date
| 2025 | Year | 07 | Month | 31 | Day |
Last modified on
| 2025 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067071
