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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030559
Receipt No. R000034890
Scientific Title The Optimal Aortic Diameter for Risk Factor of Late Aortic Events in Uncomplicated Stanford Type B Aortic Dissection
Date of disclosure of the study information 2018/01/04
Last modified on 2018/06/27

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Basic information
Public title The Optimal Aortic Diameter for Risk Factor of Late Aortic Events in Uncomplicated Stanford Type B Aortic Dissection
Acronym The Aortic Diameter for Risk Factor of Late Events in Uncomplicated Type B Aortic Dissection
Scientific Title The Optimal Aortic Diameter for Risk Factor of Late Aortic Events in Uncomplicated Stanford Type B Aortic Dissection
Scientific Title:Acronym The Aortic Diameter for Risk Factor of Late Events in Uncomplicated Type B Aortic Dissection
Region
Japan

Condition
Condition Uncomplicated acute type B aortic dissection
Classification by specialty
Cardiology Vascular surgery Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the outcomes of patients with uncomplicated acute type B aortic dissection.
Basic objectives2 Others
Basic objectives -Others We tried to identify the optimal aortic diameter for risk factor of late aortic events in uncomplicated acute type B aortic dissection.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes All cause of mortality and late aortic events; operation or indication of operation for dissected aorta
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 We conducted a retrospective cohort study reviewing consecutive patients underwent initial treatment for uncomplicated acute type B aortic dissection.
Key exclusion criteria We excluded patients with complicated acute type B aortic dissection (rupture, impending rupture, malperfusion).
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasunori Sato
Organization Graduate School of Medicine, Chiba University
Division name Department of Global Clinical Research
Zip code
Address 1-8-1, Inohana, Chuo-ku, Chiba
TEL 043-224-6507
Email yasu@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akihito Matsushita
Organization Seikeikai Chiba Medical Center
Division name Department of Cardiovascular Surgery
Zip code
Address 1-7-1, Minami-cho, Chuo-ku, Chiba
TEL 0432615111
Homepage URL
Email akihito_matsu@yahoo.co.jp

Sponsor
Institute Chiba University
Institute
Department

Funding Source
Organization Self funding
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
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 2900
Org. issuing International ID_1 Chiba University
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 千葉中央メディカルセンター(千葉)、誠馨会千葉メディカルセンター(千葉)

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 04 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
We identify the optimal aortic diameter for predictor of late aortic events was 40mm of the maximal aortic diameter in the initial CT.
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 Completed
Date of protocol fixation
2017 Year 11 Month 04 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 04 Day
Last follow-up date
2018 Year 04 Month 20 Day
Date of closure to data entry
2018 Year 04 Month 30 Day
Date trial data considered complete
2018 Year 04 Month 30 Day
Date analysis concluded
2018 Year 05 Month 15 Day

Other
Other related information We reported the optimal aortic diameter for predictors of late aortic events in 2018 Vascular annual meeting.

Management information
Registered date
2017 Year 12 Month 25 Day
Last modified on
2018 Year 06 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034890

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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