UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056836 |
|---|---|
| Receipt number | R000060733 |
| Scientific Title | Analysis of blood flow in the left atrium using 4DFlowMRI |
| Date of disclosure of the study information | 2025/01/31 |
| Last modified on | 2025/01/27 15:23:27 |
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Basic information
Public title
Analysis of blood flow in the left atrium using 4DFlowMRI
Acronym
Analysis of blood flow in the left atrium using 4DFlowMRI
Scientific Title
Analysis of blood flow in the left atrium using 4DFlowMRI
Scientific Title:Acronym
Analysis of blood flow in the left atrium using 4DFlowMRI
Region
| Japan |
Condition
Condition
Mitral Valve regurgitation
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate aortic blood flow using 4DFlowMRI to analyze the relationship between the velocity and the pressure applied to the aneurysm.
Basic objectives2
Others
Basic objectives -Others
Differences in maximal and mean blood flow velocity in the left atrium among the three groups will be analyzed, and a correlation with CHA2DS2-VASc SCORE will be demonstrated. The cutoff value for increased risk of thrombus formation will be determined based on the value of intravascular flow velocity in the left atrium.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
maximum and average blood flow velocity in left atrium
blood flow rate in left auricle
Morphology of blood flow in left atrium
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Valve surgery
Key exclusion criteria
1) Post device implantation and claustrophobic patients with MRI imaging difficulties
2) New onset of myocardial infarction or unstable angina within 28 days
3) Active bleeding disorders (gastrointestinal bleeding, trauma, etc.)
4) Pacemaker implantation
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Nakajima |
Organization
Sapporo Medical University
Division name
Cardiovascular surgery
Zip code
0608543
Address
Sapporo City South 1 West 16
TEL
011-611-2111
t.nakajima@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Nakajima |
Organization
Sapporo Medical University
Division name
Cardiovascular surgery
Zip code
060-8543
Address
Sapporo City South 1 West 16
TEL
011-611-2111
Homepage URL
t.nakajima@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Medical University
Address
Sapporo City South 1 West 16
Tel
011-611-2111
t.nakajima@sapmed.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 | 01 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 01 | Month | 27 | Day |
Last modified on
| 2025 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060733
