UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030561
Receipt No. 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 2019/06/29

* 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 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
Email 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
Email akihito_matsu@yahoo.co.jp

Sponsor
Institute Department of Global Clinical Research, Graduate school of Medicine, 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 Seikeikai Chiba Medical Center
Address 1-7-1, Minami-cho, Chuo-ku
Tel 0432615111
Email 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
Publication of results Published

Result
URL related to results and publications
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
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 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 06 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034892

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.