UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013057 |
|---|---|
| Receipt number | R000011940 |
| Scientific Title | The usefulness of cardiac MRI for evaluating myocardial fibrosis (modified T1 mapping) |
| Date of disclosure of the study information | 2014/02/03 |
| Last modified on | 2014/02/04 12:03:56 |
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Basic information
Public title
The usefulness of cardiac MRI for evaluating myocardial fibrosis (modified T1 mapping)
Acronym
Modified T1 mapping for evaluating myocardial fibrosis
Scientific Title
The usefulness of cardiac MRI for evaluating myocardial fibrosis (modified T1 mapping)
Scientific Title:Acronym
Modified T1 mapping for evaluating myocardial fibrosis
Region
| Japan |
Condition
Condition
cardiomyopathy, diastolic dysfunction, myocardial infarction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the ability of cardiac MRI modified T1 mapping method for providing useful stable index of myocardial fibrosis.
Basic objectives2
Others
Basic objectives -Others
To compare the parameter of T1 mapping with diastolic function derived from echocardiography, myocardial biopsy, oxidative stress test and metabolic profile of serum amino acids.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Conventional methods for diastolic dysfunction, amino acids relating to oxidative stress, and pathology of cardiac biopsy
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
Subjects must be or more than 20 years old at enrollment, and got informed consent.
Key exclusion criteria
patients not applicable to contrast MRI are excluded.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuyuki |
Organization
National Defense Medical College
Division name
Cardiology
Zip code
Address
3-2Namiki, Tokorozawa, Saitama, Japan
TEL
0429-95-1211
nmasaki@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Masaki |
Organization
National Defense Medical College
Division name
Cardiology
Zip code
Address
3-2Namiki,Tokorozawa
TEL
0429-95-1211
Homepage URL
nmasaki@ndmc.ac.jp
Sponsor or person
Institute
Takeshi Adachi
Institute
Department
Personal name
Funding Source
Organization
Funds of National Defense Medical College
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
| 2014 | Year | 02 | Month | 03 | 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
| 2013 | Year | 02 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
now registrating
Management information
Registered date
| 2014 | Year | 02 | Month | 03 | Day |
Last modified on
| 2014 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011940
