UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018287 |
|---|---|
| Receipt number | R000021167 |
| Scientific Title | Evaluation of clinical values of 4D flow MRI |
| Date of disclosure of the study information | 2015/07/21 |
| Last modified on | 2025/01/24 17:15:28 |
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Basic information
Public title
Evaluation of clinical values of 4D flow MRI
Acronym
Clinical values of 4D flow MRI
Scientific Title
Evaluation of clinical values of 4D flow MRI
Scientific Title:Acronym
Clinical values of 4D flow MRI
Region
| Japan |
Condition
Condition
Pulmonary hypertension, valvular disease
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the values of 4D flow MRI for monitoring pulmonary arterial pressure in patients with pulmonary hypertension, or stenosis / regurgitation in patients with vulvular disease. Especially, for observing these conditions after less-invasive therapies including CTEPH and TAVI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between 4D flow map and blood pressure or regurgitation
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
| Other |
Interventions/Control_1
Adding 4D flow MRI to the routine MRI examination
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
Patients to whom MRI examination will be planned before therapies of CTEPH or TAVI
Key exclusion criteria
1. A person who is less than 20-year-old.
2. A woman who is or supposed to be pregnant.
3. A person who has metalic implants with electronic, magnetical or mechanical operation.
4. A claustrophobia
5. A person who is judged to be inappropriate for enrolling in this study by principal or contributory investigators.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shigeo |
| Middle name | |
| Last name | Okuda |
Organization
Keio University School of Medicine
Division name
Department of Diagnostic Radiology
Zip code
160-8582
Address
Shinanomachi 35, Shinjyuku-ku, Tokyo
TEL
03-3353-1211
shige@keio.jp
Public contact
Name of contact person
| 1st name | Shigeo |
| Middle name | |
| Last name | Okuda |
Organization
keio University School of Medicine
Division name
Department of Diagnostic Radiology
Zip code
160-8582
Address
Shinanomachi 35, Shinjyuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
shige@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjyuku-ku, Tokyo
Tel
03-5363-3961
med-rinri-jimu@adst.keio.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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 21 | Day |
Related information
URL releasing protocol
10.1007/s00380-024-02361-1
Publication of results
Published
Result
URL related to results and publications
10.1007/s00380-024-02361-1
Number of participants that the trial has enrolled
27
Results
Twenty-seven patients with rTOF and seven healthy people underwent 4D flow CMR. Seven patients exhibited helical, and four patients exhibited vortical RVOT flow. The flow volume at the upper section of the pulmonary valve was the most accurate correlation of aortic flow volume. Furthermore, the 4D flow CMR using the pixel-wise method demonstrated superior accuracy compared to the traditional bulk flow method.
Results date posted
| 2025 | Year | 01 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patitents with the history of repared Tetralogy of Fallot, for whom cardiac MRI study was planned to evaluate the right ventricular function and regurgetation of pulmonary valve
Participant flow
Written informed consent was obtained from all patients to enroll this study in which 4D-Flow MRI was added to clinical CMR protocol and its data was analyzed for the study purpose.
Adverse events
None
Outcome measures
Visual assessment of flow pattern in the pulmonary artery
Measuearments of blood flow at the different position in the pulmonary artery
Concordance between the blood flow in ascending aorta and pulmonary artery
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 26 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 16 | Day |
Last follow-up date
| 2022 | 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
| 2015 | Year | 07 | Month | 13 | Day |
Last modified on
| 2025 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021167
