UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047125 |
|---|---|
| Receipt number | R000053755 |
| Scientific Title | The investigation of the relationship between the morphology of coronary atherosclerosis and gene information in coronary artery disease patients. |
| Date of disclosure of the study information | 2022/05/01 |
| Last modified on | 2022/03/09 13:43:28 |
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Basic information
Public title
The investigation of the relationship between the morphology of coronary atherosclerosis and gene information in coronary artery disease patients.
Acronym
The investigation of gene information in CAD patients.
Scientific Title
The investigation of the relationship between the morphology of coronary atherosclerosis and gene information in coronary artery disease patients.
Scientific Title:Acronym
The investigation of the relationship between the morphology of coronary atherosclerosis and gene information in coronary artery disease patients.
Region
| Japan |
Condition
Condition
Coronary artery disease patients
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify the involvement of somatic mutation in blood and coronary culprit plaques in coronary artery disease patients.
Basic objectives2
Others
Basic objectives -Others
To clarify the relationship between the somatic mutation and the morphology of coronary culprit plaques revealed by single cell RNA and ATAC seq
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The existence of somatic mutation in blood and coronary culprit plaques
Key secondary outcomes
1, The ratio of somatic mutation and the place in gene map of somatic mutation.
2, CT or MRI evaluation of coronary plaques
3, Histological evaluation
4, Single cell RNA and ATAC sequencing of blood and coronary culprit plaque samples
5, The interaction of somatic mutations and single cell RN and ATAC sequencing of blood and coronary culprit plaque samples.
6, Metabolomics in plasma
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
1, Patients of 20 year of age or over
2, Patients who are candidates for DCA
3, Patients for whom written consent has been obtained by the individual
Key exclusion criteria
Patients taking steroids or undergoing treatment for cancer, or suffering from hepatitis B and C viruses
Other patients who are deemed inappropriate by the physician in charge of the study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tomoya |
| Middle name | |
| Last name | Yamashita |
Organization
Kobe University School of Medicine
Division name
Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code
650-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan
TEL
078-382-5846
tomoya@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoya |
| Middle name | |
| Last name | Yamashita |
Organization
Kobe University School of Medicine
Division name
Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code
650-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan
TEL
078-382-5846
Homepage URL
tomoya@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University School of Medicine, Division of Cardiovascular Medicine, Department of Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University School of Medicine
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan
Tel
078-382-5111
chiken@med.kobe-u.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 | 05 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 03 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 09 | Day |
Last modified on
| 2022 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053755
