UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024558 |
|---|---|
| Receipt number | R000028263 |
| Scientific Title | Effect of left and right recumbent positions on hemodynamics in healthy adults by using MRI |
| Date of disclosure of the study information | 2016/12/01 |
| Last modified on | 2020/04/28 09:04:41 |
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Basic information
Public title
Effect of left and right recumbent positions on hemodynamics in healthy adults by using MRI
Acronym
Effect of recumbent positions on hemodynamics
Scientific Title
Effect of left and right recumbent positions on hemodynamics in healthy adults by using MRI
Scientific Title:Acronym
Effect of recumbent positions on hemodynamics
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Hepato-biliary-pancreatic medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the influence of left and right recumbent positions on hemodynamics in healthy adults.
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in hemodynamics in supine, left recumbent and right recumbent positions.
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
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
MRI study is performed once in supine, left recumbent and right recumbent positions.
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
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
No history of respiratory or cardiovascular diseases
Taking no regular medications
Key exclusion criteria
Obesity (BMI over 30)
Adults with claustrophobia
Pregnant adults
Adults under 20 of age
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Konosuke |
| Middle name | |
| Last name | Sasaki |
Organization
Tohoku University Graduate School of Medicine
Division name
Cardiovasuclar surgery
Zip code
9818574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7226
konosuke.s@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Konosuke |
| Middle name | |
| Last name | Sasaki |
Organization
Tohoku University Graduate School of Medicine
Division name
Cardiovasuclar surgery
Zip code
9818574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7226
Homepage URL
konosuke.s@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
North Japan Academy of Nursing Science
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
Tohoku University School of Medicine, IRB
Address
1-1, Seiryo-machi, Aoba-ku, Sendai
Tel
022-717-8007
med-kenkyo@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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 01 | 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
12
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Under analysis
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | 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
| 2016 | Year | 10 | Month | 25 | Day |
Last modified on
| 2020 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028263
