UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047439 |
|---|---|
| Receipt number | R000049107 |
| Scientific Title | The research about the pathogenesis of aortic dissection and aortic aneurysm |
| Date of disclosure of the study information | 2022/05/01 |
| Last modified on | 2023/04/09 23:22:20 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The research about the pathogenesis of aortic dissection and aortic aneurysm
Acronym
The research about the pathogenesis of aortic dissection and aortic aneurysm
Scientific Title
The research about the pathogenesis of aortic dissection and aortic aneurysm
Scientific Title:Acronym
The research about the pathogenesis of aortic dissection and aortic aneurysm
Region
| Japan |
Condition
Condition
Aortic Aneurysm
Aortic Dissection
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The mechanisms of aortic aneurysm and aortic dissection are unknown. The purpose of this research is to solve the mechanism of aortic aneurysm and dissection, and development of new prevention and therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
expression of gene resulting in aortic dissection or aortic aneurysm
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with aortic dissection or aortic aneurysm for surgical indication.
Key exclusion criteria
Patients excluded by the attending physician from an ethical point of view and patients with infectious diseases requiring treatment
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | KENJI |
| Middle name | |
| Last name | OKADA |
Organization
Department of Surgery, Kobe University Graduate School of Medicine
Division name
Division of Cardiovascular Surgery
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL
0783825942
kokada@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | KATSUHIRO |
| Middle name | |
| Last name | YAMANAKA |
Organization
Department of Surgery, Kobe University Graduate School of Medicine
Division name
Division of Cardiovascular Surgery
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL
0783825942
Homepage URL
yamanaka@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe university
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Hospital Medical Information Network
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
Tel
0783826669
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
神戸大学病院
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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 05 | Month | 07 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Single-cell RNA sequencing analysis of aortic samples obtained during aortic aneurysm and aortic dissection surgery. Aortic samples obtained during central anastomosis of the great saphenous vein in coronary artery bypass surgery will be compared as control samples to identify genes specific to aortic dissection and aortic aneurysm.
Management information
Registered date
| 2022 | Year | 04 | Month | 08 | Day |
Last modified on
| 2023 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049107
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
