UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030561 |
|---|---|
| Receipt number | R000034892 |
| Scientific Title | Derivatin and Validation of a Risk Prediction Score for Late Aortic Events in Uncomplicated Stanford Type B Aortic Dissection |
| Date of disclosure of the study information | 2018/01/20 |
| Last modified on | 2019/12/15 19:20:50 |
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Basic information
Public title
Derivatin and Validation of a Risk Prediction Score for Late Aortic Events in Uncomplicated Stanford Type B Aortic Dissection
Acronym
Derivatin and Validation of a Risk Prediction Score for Late Aortic Events in Uncomplicated Type B Aortic Dissection
Scientific Title
Derivatin and Validation of a Risk Prediction Score for Late Aortic Events in Uncomplicated Stanford Type B Aortic Dissection
Scientific Title:Acronym
Derivatin and Validation of a Risk Prediction Score for Late Aortic 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
We develop a risk prediction score for late aortic events in patients with uncomplicated acute type B aortic dissection.
Basic objectives2
Others
Basic objectives -Others
We validate our prediction score for late
aortic events.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Aortic death 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
(1) We conducted a retrospective cohort study reviewing consecutive patients underwent initial treatment for uncomplicated acute type B aortic dissection in our institute to derivate a risk prediction score.
(2) We validate the risk prediction score with patients underwent initial treatment for uncomplicated acute type B aortic dissection at another hospital.
Key exclusion criteria
We excluded patients with complicated acute type B aortic dissection (rupture, impending rupture, malperfusion).
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Yasunori |
| Middle name | |
| Last name | Sato |
Organization
Chiba University, Graduate school of Medicine
Division name
Department of Global Clinical Research
Zip code
260-8670
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 | Akihito |
| Middle name | |
| Last name | Matsushita |
Organization
Seikeikai Chiba Medical Center
Division name
Department of Cardiovascular Surgery
Zip code
260-0842
Address
1-7-1, Minami-cho, Chuo-ku
TEL
0432615111
Homepage URL
akihito_matsu@yahoo.co.jp
Sponsor or person
Institute
Department of Global Clinical Research, Graduate school of Medicine, 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
Seikeikai Chiba Medical Center
Address
1-7-1, Minami-cho, Chuo-ku
Tel
0432615111
akihito_matsu@yahoo.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2901
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）、千葉メディカルセンター（千葉）、千葉大学（千葉）、倉敷中央病院（岡山県）、榊原記念病院（東京都）、新東京病院（千葉）、東京ベイ浦安市川医療センター（千葉）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 20 | Day |
Related information
URL releasing protocol
https://www.clinicalkey.jp/#!/content/playContent/1-s2.0-S0022522319312760?returnurl=https:%2F%2Flin
Publication of results
Published
Result
URL related to results and publications
https://www.clinicalkey.jp/#!/content/playContent/1-s2.0-S0022522319312760?returnurl=https:%2F%2Flin
Number of participants that the trial has enrolled
406
Results
The risk prediction score system was developed using the following independent predictors: initial aortic diameter of >= 40 mm (2 points), false lumen diameter > true lumen diameter (2 points), ulcer-like projection (1 point), and age of >= 70 years (1 point). ROC analysis showed that a cut-off total additive score of 2 points. In the validation cohort, the low-risk group (score of 0-1 points) demonstrated lower 1- and 3-year incidence rates of late aortic events than the high-risk group.
Results date posted
| 2019 | Year | 06 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 06 | Month | 14 | Day |
Baseline Characteristics
Uncomplicated type B aortic dissection
Participant flow
Initial medication and outpatient follow up
Adverse events
No
Outcome measures
Operation, operative indication, mortality
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will develop and validate a risk prediction score for late aortic events in patients with uncomplicated acute type B aortic dissection.
Management information
Registered date
| 2017 | Year | 12 | Month | 25 | Day |
Last modified on
| 2019 | 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=R000034892
