UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Impact of Initial Aortic Diameter and The Larger Area Ratio of False Lumen on Stanford Type B Aortic Dissection Prognosis
Title of the study (Brief title)	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	Yasunori Sato
Organization	Graduate School of Medicine, Chiba University
Division name	Department of Global Clinical Research
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	Akihito Matsushita
Organization	Seikeikai Chiba Medical Center
Division name	Department of Cardiovascular Surgery
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://academic.oup.com/icvts/advance-article/doi/10.1093/icvts/ivx286/4469403
Results
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/icdr_e/ctr_view.cgi?recptno=R000029229