UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040686 |
|---|---|
| Receipt number | R000046440 |
| Scientific Title | Late aortic surgery methods and timing for patients with uncomplicated type B aortic dissection |
| Date of disclosure of the study information | 2020/06/08 |
| Last modified on | 2023/12/15 09:38:39 |
* 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
Late aortic surgery methods and timing for patients with uncomplicated type B aortic dissection
Acronym
Late aortic surgery methods and timing for type B dissection
Scientific Title
Late aortic surgery methods and timing for patients with uncomplicated type B aortic dissection
Scientific Title:Acronym
Late aortic surgery methods and timing for type B dissection
Region
| Japan |
Condition
Condition
Stanford type B acute aortic dissection
Classification by specialty
| Vascular surgery | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the outcomes of patients with uncomplicated type B aortic dissection who need aortic care at the chronic phase.
Basic objectives2
Others
Basic objectives -Others
We tried to identify the predictors of life prognosis.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
All-cause of death
Key secondary outcomes
Aortic related death
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 with aortic events at the chronic phase in consecutive patients who underwent initial treatment for Uncomplicated type B acute aortic dissection.
Key exclusion criteria
We excluded patients with complicated ATBAD (rupture, impending rupture, malperfusion) or patients with chronic type B aortic dissection.
Target sample size
100
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
2600842
Address
1-7-1, minami-cho, Chuo-ku, Chiba
TEL
09052982354
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
2600842
Address
1-7-1, minami-cho, Chuo-ku
TEL
09052982354
Homepage URL
akihito_matsu@yahoo.co.jp
Sponsor or person
Institute
Seikeikai Chiba Medical Center
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
Seikeikai Chiba Medical Center
Address
1-7-1, minami-cho, Chuo-ku
Tel
09052982354
akihito_matsu@yahoo.co.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
誠馨会千葉メディカルセンター
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 08 | Day |
Related information
URL releasing protocol
Preparation
Publication of results
Partially published
Result
URL related to results and publications
Preparation
Number of participants that the trial has enrolled
104
Results
We were unable to identify an improvement in prognosis based on surgical treatment at the chronic phase for UTBAD patients.
Results date posted
| 2022 | Year | 04 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This retrospective review of 106 consecutive patients with aortic events at the chronic phase who underwent initial treatment for UTBAD.
Participant flow
The study subjects comprised two groups: patients who underwent surgical treatment (ST), including both TEVAR and OR, and patients who continued only medical therapy (MT).
Adverse events
Aortic events
Outcome measures
All cause of death
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2019 | Year | 05 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 04 | Month | 20 | Day |
Other
Other related information
We finished follow the patients. We are writing an article.
Management information
Registered date
| 2020 | Year | 06 | Month | 08 | Day |
Last modified on
| 2023 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046440
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
