UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030559 |
|---|---|
| Receipt number | 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 18:58:23 |
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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
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
akihito_matsu@yahoo.co.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034890
