UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051656 |
|---|---|
| Receipt number | R000058943 |
| Scientific Title | Elucidation of the pathogenesis of coronary microvascular disease in hypertrophic cardiomyopathy |
| Date of disclosure of the study information | 2023/07/20 |
| Last modified on | 2025/07/22 12:26:47 |
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Basic information
Public title
Elucidation of the pathogenesis of coronary microvascular disease in hypertrophic cardiomyopathy
Acronym
Elucidation of the pathogenesis of coronary microvascular disease in hypertrophic cardiomyopathy
Scientific Title
Elucidation of the pathogenesis of coronary microvascular disease in hypertrophic cardiomyopathy
Scientific Title:Acronym
Elucidation of the pathogenesis of coronary microvascular disease in hypertrophic cardiomyopathy
Region
| Japan |
Condition
Condition
Hypertrophic cardiomyopathy
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the coronary microvascular disease in hypertrophic cardiomyopathy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Degree of coronary microvascular disease in hypertrophic cardiomyopathy
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
cardiac catheterization
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
Patients diagnosed with hypertrophic cardiomyopathy and undergoing cardiac catheterization in routine practice.
Key exclusion criteria
Patients who did not give consent or who refused to donate.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yuichiro |
| Middle name | |
| Last name | Maekawa |
Organization
Hamamatsu University School of Medicine Hospital
Division name
Cardiology
Zip code
431-3192
Address
1-20-1 Handayama, Higashi Ward, Hamamatsu City, Shizuoka Prefecture
TEL
053-435-2267
tesato@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Terumori |
| Middle name | |
| Last name | Sato |
Organization
Hamamatsu University School of Medicine Hospital
Division name
Cardiology
Zip code
431-3192
Address
1-20-1 Handayama, Higashi Ward, Hamamatsu City, Shizuoka Prefecture
TEL
053-435-2267
Homepage URL
tesato@hama-med.ac.jp
Sponsor or person
Institute
other
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
Terumori Sato
Address
1-20-1 Handayama, Higashi Ward, Hamamatsu City, Shizuoka Prefecture
Tel
053-435-2267
tesato@hama-med.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
| 2023 | Year | 07 | Month | 20 | 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
| 2023 | Year | 07 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 11 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study is currently ongoing as a clinical research project, and patient enrollment is actively being conducted.
However, the case registration system created within UMIN-CTR was mistakenly constructed due to a misinterpretation of the initial study operations, and it has not been used in the actual conduct of the study.
Since the case registration function within UMIN is not required, we have marked the trial status as "terminated" on UMIN-CTR, although the study itself remains active.
Management information
Registered date
| 2023 | Year | 07 | Month | 20 | Day |
Last modified on
| 2025 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058943
