UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036415 |
|---|---|
| Receipt number | R000041485 |
| Scientific Title | Potential Ability of Cardiac MRI to Predict Efficacy after Cardiac Resynchronization Therapy |
| Date of disclosure of the study information | 2019/04/05 |
| Last modified on | 2021/06/01 13:29:30 |
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Basic information
Public title
Potential Ability of Cardiac MRI to Predict Efficacy after Cardiac Resynchronization Therapy
Acronym
Potential Ability of Cardiac MRI to Predict Efficacy after Cardiac Resynchronization Therapy
Scientific Title
Potential Ability of Cardiac MRI to Predict Efficacy after Cardiac Resynchronization Therapy
Scientific Title:Acronym
Potential Ability of Cardiac MRI to Predict Efficacy after Cardiac Resynchronization Therapy
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the predictor of beneficial outcome after CRT implantation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of left ventricular function after cardiac resynchronization therapy.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Among patients who recieved CRT implantation between 2010 and 2016, we will include population whose cardiac MRI data before CRT implantation were available.
Key exclusion criteria
Less than 20 years old
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Matsumoto |
Organization
Tokai University Hospital
Division name
Cardiology department
Zip code
259-1193
Address
143, Shimokasuya, Iseharashi, Kanagawa, Japan
TEL
0463931121
shingomatsumoto0606@gmail.com
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Matsumoto |
Organization
Tokai University Hospital
Division name
Cardiology department
Zip code
259-1193
Address
143, Shimokasuya, Iseharashi, Kanagawa, Japan
TEL
0463931121
Homepage URL
shingomatsumoto0606@gmail.com
Sponsor or person
Institute
Tokai University Hospital
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
Tokai University Hospital
Address
143, Shimokasuya, Iseharashi
Tel
0463931121
shingomatsumoto0606@gmail.com
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
| 2019 | Year | 04 | Month | 05 | 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
130
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 | 08 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 24 | 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
None.
Management information
Registered date
| 2019 | Year | 04 | Month | 05 | Day |
Last modified on
| 2021 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041485
