UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056825 |
|---|---|
| Receipt number | R000064944 |
| Scientific Title | Inter-CMD registry |
| Date of disclosure of the study information | 2025/03/01 |
| Last modified on | 2025/01/27 09:43:34 |
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Basic information
Public title
International CMD registry study by COVADIS and J-CMD
Acronym
Inter-CMD registry
Scientific Title
Inter-CMD registry
Scientific Title:Acronym
Inter-CMD registry
Region
| Japan | North America | Australia |
| Europe |
Condition
Condition
Coronary microvascular dysfunction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
There is a growing recognition of the significance of CMD in the etiology of chronic coronary syndrome. Although we performed the first international registry study on CMD, many issues remain to be elucidated, including the long-term prognosis, left ventricular functions, and useful biomarkers. In this study, we aim to establish the "International Association of Coronary Microvascular Dysfunction (Inter-CMD)" and collaborate with institutions worldwide to establish the evidence.
Basic objectives2
Others
Basic objectives -Others
To establish the "International Association of Coronary Microvascular Dysfunction (Inter-CMD)" and collaborate with research institutions worldwide to build evidence for CMD.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Clinical characteristics and long-term prognosis of CMD patients.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing cardiac catheterization for the purpose of investigating chest symptoms (such as coronary spasm induction test or coronary microcirculation function test).
Key exclusion criteria
Patients who cannot undergo the cardiac catheterization due to general health conditions or other reasons.
Target sample size
2400
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
Zip code
286-8686
Address
4-3, Kozunomori, Narita,Chiba, Japan
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, Tochigi, Japan
TEL
0287372221
Homepage URL
mtakeda@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Abbott Medical
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Trial Management Department, International University of Health and Welfare
Address
852 Hatakeda Narita, Chiba, JAPAN
Tel
0476355607
iuhw-irb@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
| 2025 | Year | 03 | 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
| 2024 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Inter-CMD is a registry study that enroll patients diagnosed with vasospastic angina and microvascular dysfunction through invasive diagnostic procedure and observe their prognosis. No interventions were performed.
Management information
Registered date
| 2025 | Year | 01 | Month | 27 | Day |
Last modified on
| 2025 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064944
