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 UMIN000025388
Receipt No. R000029229
Scientific Title The Impact of Initial Aortic Diameter and The Larger Area Ratio of False Lumen on Stanford Type B Aortic Dissection Prognosis
Date of disclosure of the study information 2016/12/24
Last modified on 2017/12/25

* 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 The Impact of Initial Aortic Diameter and The Larger Area Ratio of False Lumen on Stanford Type B Aortic Dissection Prognosis
Acronym Predictors for Adverse Events in Stanford Type B Acute Aortic Dissection
Scientific Title The Impact of Initial Aortic Diameter and The Larger Area Ratio of False Lumen on Stanford Type B Aortic Dissection Prognosis
Scientific Title:Acronym Predictors for Adverse Events in Stanford Type B Acute Aortic Dissection
Region
Japan

Condition
Condition Acute Stanford Type B Aortic Dissection
Classification by specialty
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 acute type B aortic dissection at our institute.
Basic objectives2 Others
Basic objectives -Others We tried to identify the risk of major adverse events.
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes All cause of mortality
Key secondary outcomes late operation or indication of operation for dissected aorta

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
20 years-old <=
Age-upper limit
100 years-old >=
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 in our institute.
Key exclusion criteria We excluded patients with complicated cases (rupture, impending rupture, malperfusion).
Target sample size 130

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, Japan
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, Japan
TEL 043-261-5111
Homepage URL
Email afwa7417@chiba-u.jp

Sponsor
Institute Department of Global Clinical Research, Graduate School of Medicine, Chiba University
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
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 CMC2016-05
Org. issuing International ID_1 Seikeikai Chiba Medical Center
Study ID_2
Org. issuing International ID_2
IND to MHLW

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

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 24 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://academic.oup.com/icvts/advance-article/doi/10.1093/icvts/ivx286/4469403
Number of participants that the trial has enrolled
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 Completed
Date of protocol fixation
2016 Year 12 Month 05 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 24 Day
Last follow-up date
2017 Year 01 Month 10 Day
Date of closure to data entry
2017 Year 01 Month 15 Day
Date trial data considered complete
2017 Year 01 Month 15 Day
Date analysis concluded
2017 Year 01 Month 20 Day

Other
Other related information We conducted a retrospective cohort study reviewing 134 consecutive patients underwent initial treatment for uncomplicated acute type B aortic dissection between October 2004 and May 2015.

Management information
Registered date
2016 Year 12 Month 23 Day
Last modified on
2017 Year 12 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029229

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.