UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027984 |
|---|---|
| Receipt number | R000031995 |
| Scientific Title | Dynamic Changes in Mitral Valve Geometry During Hand Grip Exercise and Its Association With Exercise Induced Mitral Regurgitation A Real Time 3 Dimentional Transesophageal Echocardiography Study |
| Date of disclosure of the study information | 2017/06/28 |
| Last modified on | 2019/05/13 20:54:00 |
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Basic information
Public title
Dynamic Changes in Mitral Valve Geometry During Hand Grip Exercise and Its Association With Exercise Induced Mitral Regurgitation
A Real Time 3 Dimentional Transesophageal Echocardiography Study
Acronym
Dynamic Changes in Mitral Valve Geometry During Hand Grip Exercise and Its Association With Exercise
Scientific Title
Dynamic Changes in Mitral Valve Geometry During Hand Grip Exercise and Its Association With Exercise Induced Mitral Regurgitation
A Real Time 3 Dimentional Transesophageal Echocardiography Study
Scientific Title:Acronym
Dynamic Changes in Mitral Valve Geometry During Hand Grip Exercise and Its Association With Exercise
Region
| Japan |
Condition
Condition
Mitral regurgitation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this 3D-TEE study is to define a relationship between the dynamic changes in mitral valve geometry during hand-grip exercise and exercise induced mitral regurgitation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The changes of mitral rigurgitation during hand-grip exercise
Key secondary outcomes
Geometric changes in the mitral valve complex
Hemodynamic parameters
exercise tolerability
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
| Maneuver |
Interventions/Control_1
Hand-grip exercise
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
Written informed consent is obtained from the patients
Patients with more than 20 years old
Patients who has more than moderate mitral regurgitation
Key exclusion criteria
The patients who can not load hand grip
The patients with more than moderate valvular disease other than mitral regurgitation
The patients who underwent valvular disease surgery
The patients with unstable hemodynamic state
The patients who were found unfit to be respondent to a survey by physician incharge
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroto Utsunomiya |
Organization
Hiroshima University
Division name
Department of Cardiovascular Medicine, Graduate School of Biomedical & Health Sciences
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5540
hiroto.utsu@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yu Harada |
Organization
Hiroshima University
Division name
Department of crdiovascular Medicine, Graduate School of Biomedical & Health Sciences
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5540
Homepage URL
dokkyotakiguchi@yahoo.co.jp
Sponsor or person
Institute
Department of crdiovascular Medicine, Graduate School of Biomedical & Health Sciences,Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
none
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
Address
Tel
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
| 2017 | Year | 06 | Month | 28 | 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
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 28 | Day |
Last follow-up date
| 2019 | 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
| 2017 | Year | 06 | Month | 28 | Day |
Last modified on
| 2019 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031995
