UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047609 |
|---|---|
| Receipt number | R000054290 |
| Scientific Title | Multicenter Study for the Evidence of Japanese Patients with Coronary Microvascular Dysfunction |
| Date of disclosure of the study information | 2022/06/01 |
| Last modified on | 2023/04/30 11:46:23 |
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Basic information
Public title
Multicenter Study for the Evidence of Japanese Patients with Coronary Microvascular Dysfunction
Acronym
J-CMD
Scientific Title
Multicenter Study for the Evidence of Japanese Patients with Coronary Microvascular Dysfunction
Scientific Title:Acronym
J-CMD
Region
| Japan |
Condition
Condition
Coronary Microvascular Dysfunction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To develop the evidence of coronary microvascular dysfunction in Japanese patients
Basic objectives2
Others
Basic objectives -Others
To provide the comprehensive data on the pathogenesis of coronary microvascular dysfunction using functional, histological, molecular biological, and genomic approaches
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Correlation between coronary microvascular dysfunction and expression of coronary endothelium- / smooth muscle cells- related molecules
2. Correlation between coronary microvascular dysfunction and gene abnormalities of coronary endothelium- / smooth muscle cells- related molecules
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with angina symptoms and/or signs of ischemia who undergo coronary angiography
Key exclusion criteria
Patients who are unable to undergo coronary angiography because of the worsening of general condition
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Shimokawa |
Organization
International University of Health and Welfare
Division name
Graduate School of Medicine
Zip code
286-8686
Address
4-3, Kozunomori, Narita-shi, Chiba-ken
TEL
0476-20-7701
shimo@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Morihiko |
| Middle name | |
| Last name | Takeda |
Organization
International University of Health and Welfare Hospital
Division name
Cardiovascular Medicine
Zip code
329-2763
Address
537-3, Iguchi, Nasushiobara-shi, Tochigi-ken
TEL
0287-37-2221
Homepage URL
mtakeda@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Japan Heart Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare
Address
4-3, Kozunomori, Narita-shi, Chiba-ken
Tel
0476-20-7701
shimo@iuhw.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
| 2022 | Year | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 07 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We prospectively follow the patients who diagnosed as coronary microvascular dysfunction by using invasive coronary functional test.
Management information
Registered date
| 2022 | Year | 04 | Month | 27 | Day |
Last modified on
| 2023 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054290
| Research Plan | |
|---|---|
| Registered date | File name |
| 2024/10/28 | 【2024年4月】 研究計画書（下川）.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2024/10/28 | DB定義書.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2024/10/28 | 施設別集計_2024-10-04T06_50_50.xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/54290
