UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033120 |
|---|---|
| Receipt number | R000037772 |
| Scientific Title | Assessment of myocardial fibrosis and coronary flow reserve in diabetic heart failure patients: Elucidation of pathogenesis and risk stratification by cardiac magnetic resonance |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2022/04/24 19:30:19 |
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Basic information
Public title
Assessment of myocardial fibrosis and coronary flow reserve in diabetic heart failure patients: Elucidation of pathogenesis and risk stratification by cardiac magnetic resonance
Acronym
Assessment of myocardial fibrosis and coronary flow reserve in diabetic heart failure patients: Elucidation of pathogenesis and risk stratification by cardiac magnetic resonance
Scientific Title
Assessment of myocardial fibrosis and coronary flow reserve in diabetic heart failure patients: Elucidation of pathogenesis and risk stratification by cardiac magnetic resonance
Scientific Title:Acronym
Assessment of myocardial fibrosis and coronary flow reserve in diabetic heart failure patients: Elucidation of pathogenesis and risk stratification by cardiac magnetic resonance
Region
| Japan |
Condition
Condition
Heart failure patients with diabetes mellitus
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the utility of myocardial fibrosis and coronary flow reserve assessed by cardiac magnetic resonance for elucidation of pathogenesis and risk stratification for diabetic heart failure patients.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment of myocardial fibrosis by T1 mapping and coronary flow reserve by phase contrast cine MRI of the coronary sinus
Relationship between fibrosis/CFR and prognosis
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Diabetic heart failure patients who performed assessment of myocardial fibrosis and coronary flow reserve by cardiac magnetic resonance
Non-diabetic heart failure patients will be included in this study.
Key exclusion criteria
Patients who couldn't complete MRI scan
Patients having persistent left side vena cava
Patients with eGFR<30ml/min/1.73m2
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shingo Kato |
Organization
Kanagawa Cardiovascular and respiratory Center
Division name
Department of Cardiology
Zip code
Address
6-16-1, Tomiokahigashi, Kanazawaku, Yokohama, Kanagawa
TEL
045-701-9581
shingo.m12226@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shingo Kato |
Organization
Kanagawa Cardiovascular and respiratory Center
Division name
Department of Cardiology
Zip code
Address
6-16-1, Tomiokahigashi, Kanazawaku, Yokohama, Kanagawa
TEL
045-701-9581
Homepage URL
shingo.m12226@gmail.com
Sponsor or person
Institute
Kanagawa Cardiovascular and respiratory Center
Institute
Department
Personal name
Funding Source
Organization
MSD Life Science Foundation, Public Interest Incorporated Foundation
Japanese Circulation Society
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
| 2018 | Year | 07 | 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
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
Terminated
Date of protocol fixation
| 2018 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 04 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective observational study
Management information
Registered date
| 2018 | Year | 06 | Month | 23 | Day |
Last modified on
| 2022 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037772
