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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040686
Receipt No. 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 2021/06/08

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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

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
Email 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
Email akihito_matsu@yahoo.co.jp

Sponsor
Institute Seikeikai Chiba Medical Center
Institute
Department

Funding Source
Organization No

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
Tel 09052982354
Email 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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 104
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 No longer recruiting
Date of protocol fixation
2019 Year 05 Month 13 Day
Date of IRB
2019 Year 06 Month 20 Day
Anticipated trial start date
2019 Year 09 Month 01 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
2020 Year 12 Month 31 Day
Date trial data considered complete
2021 Year 02 Month 27 Day
Date analysis concluded
2021 Year 03 Month 31 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
2021 Year 06 Month 08 Day


Link to view the page
URL(English) https://upload.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


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