UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036997 |
|---|---|
| Receipt number | R000042153 |
| Scientific Title | Expansion of false lumen lead to rapid aortic enlargement in Stanford Type B aortic dissection |
| Date of disclosure of the study information | 2019/06/07 |
| Last modified on | 2022/04/28 17:22:42 |
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Basic information
Public title
Expansion of false lumen lead to rapid aortic enlargement in Stanford Type B aortic dissection
Acronym
The impact of false lumen expansion in type B aortic dissection
Scientific Title
Expansion of false lumen lead to rapid aortic enlargement in Stanford Type B aortic dissection
Scientific Title:Acronym
The impact of false lumen expansion in type B aortic dissection
Region
| Asia(except Japan) |
Condition
Condition
Stanford type B acute aortic dissection
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of study is to evaluate the impact of the false lumen diameter > the true lumen diameter.
Basic objectives2
Others
Basic objectives -Others
We investigate to detect the risk factor of late aortic events for patients with uncomplicated Type B aortic dissection
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
death from aortic events,surgery for dissected aorta, indication of surgery
Key secondary outcomes
The expansion rate of dissected aorta, especially in first 6 months after onset.
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
Uncomplicated stanford type B acute aortic dissection
Key exclusion criteria
non-acute case, complicated case
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Akihito |
| Middle name | |
| Last name | Matsushita |
Organization
Seikeikai Chiba Medical Center
Division name
Cardiovascular surgery
Zip code
260-0842
Address
1-7-1, minami-cho, chuo-ku, chiba
TEL
043-261-5111
akihito_matsu@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Akihito |
| Middle name | |
| Last name | Matsushita |
Organization
Seikeikai Chiba Medical Center
Division name
Cardiovascular surgery
Zip code
260-0842
Address
1-7-1, minami-cho, chuo-ku, chiba
TEL
043-261-5111
Homepage URL
akihito_matsu@yahoo.co.jp
Sponsor or person
Institute
Seikeikai Chiba Medical Center
Cardiovascular surgery
Institute
Department
Personal name
Funding Source
Organization
Seikeikai Chiba Medical Center
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
Seikeikai Chiba Medical Center
Address
1-7-1, minami-cho, chuo-ku, chiba
Tel
043-261-5111
matsushita@seikeikai-cmc.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
| 2019 | Year | 06 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
216
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
We are going to do follow up research.
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
Completed
Date of protocol fixation
| 2019 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 05 | Month | 31 | Day |
Other
Other related information
The study was finished. We wrote an article.
Management information
Registered date
| 2019 | Year | 06 | Month | 07 | Day |
Last modified on
| 2022 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042153
