UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054015 |
|---|---|
| Receipt number | R000061666 |
| Scientific Title | The evaluation of coronary plaque using imaging modalities |
| Date of disclosure of the study information | 2024/03/30 |
| Last modified on | 2024/03/30 13:05:16 |
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Basic information
Public title
The evaluation of coronary plaque using imaging modalities
Acronym
The evaluation of coronary plaque using imaging modalities
Scientific Title
The evaluation of coronary plaque using imaging modalities
Scientific Title:Acronym
The evaluation of coronary plaque using imaging modalities
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the diagnostic accuracy of coronary plaque by intravascular ultrasound and optical coherence tomography using pathology and micro-computed tomography.
Basic objectives2
Others
Basic objectives -Others
diagnostic accuracy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Diagnostic capability of lipid and calcification
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
Individuals who died during hospitalization in the division of cardiovascular medicine and receive autopsy.
Individuals who give written informed consent from the representative for participating study.
Key exclusion criteria
Individuals who do not give written informed consent from the representative for participating study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Jinnouchi |
Organization
Saitama Medical Center, Jichi Medical University
Division name
Division of Cardiovascular Medicine
Zip code
330-8503
Address
1-847 Amanuma, Omiya, Saitama, Japan
TEL
+81-48-647-2111
Hiroyuki-j@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Jinnouchi |
Organization
Saitama Medical Center, Jichi Medical University
Division name
Division of Cardiovascular Medicine
Zip code
330-8503
Address
1-847 Amanuma, Omiya, Saitama, Japan, 330-8503
TEL
+81-48-647-2111
Homepage URL
Hiroyuki-j@jichi.ac.jp
Sponsor or person
Institute
Saitama Medical Center, Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tokai University Hospital
Tokai University Imaging Center for Advanced Research
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB in Saitama Medical Center, Jichi Medical University
Address
1-847 Amanuma, Omiya, Saitama, Japan, 330-8503
Tel
048-647-2111
s-suishin@jichi.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
| 2024 | Year | 03 | Month | 30 | 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
| 2024 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 30 | 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
Enrollment:
Individuals who died during hospitalization in the division of cardiovascular medicine and receive autopsy.
Individuals who give written informed consent from the representative for participating study.
The beginning date: 30 March, 2024
Evaluation: Calcification and lipid
Management information
Registered date
| 2024 | Year | 03 | Month | 30 | Day |
Last modified on
| 2024 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061666
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
