UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A retrospective observational study of the risk factors for abdominal aortic aneurysm expansion
Title of the study (Brief title)	A retrospective observational study of the risk factors for abdominal aortic aneurysm expansion
Region	Japan

Condition
Condition	abdominal aortic aneurysm
Classification by specialty	Vascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To deduce risk factors for abdominal aortic aneurysm expansion
Basic objectives2	Others
Basic objectives -Others	Exploratory research of abdominal aortic aneurysm exoansion
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Abdominal aortic aneurysm expansion rate defined as the difference in the maximum short axis diameter between the follow-up and initial computed tomography scans divided by the interval between the scans and was expressed in a unit of mm/year
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with infrarenal and fusiform abdominal aortic aneurysms who had either undergone surgery for an abdominal aortic aneurysm or who were being followed up for small-diameter abdominal aortic aneurysm at Tohoku University Hospital from April 2012 to March 2016, and who had undergone at least two computed tomography scan
Key exclusion criteria	We excluded patients with inflammatory, infectious, or saccular abdominal aortic aneurysms, patients with inherited vascular disorders, such as Marfan syndrome, and patients on dialysis.
Target sample size	200

Research contact person
Name of lead principal investigator	Hitoshi Goto
Organization	Tohoku University Hospital
Division name	Department of Transplantation, Reconstruction and Endoscopic Surgery
Address	1-1 Seiryo-cho, Aoba-ku, Sendai city, 980-8574, Japan
TEL	022-717-7214
Email	h-goto@med.tohoku.ac.jp

Public contact
Name of contact person	Yuta Tajima
Organization	Tohoku University Hospital
Division name	Department of Transplantation, Reconstruction and Endoscopic Surgery
Address	1-1 Seiryo-cho, Aoba-ku, Sendai city, 980-8574, Japan
TEL	022-717-7214
Homepage URL	http://www.med.tohoku.ac.jp/public/doc/2016-1-481.pdf
Email	yuta_taji_1061@msc.biglobe.ne.jp

Sponsor
Institute	Tohoku University Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 05 Month 01 Day
Anticipated trial start date	2017 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://doi.org/10.1253/circj.CJ-16-0902
Results
Other related information	Retrospective observational study

Management information
Registered date	2017 Year 02 Month 25 Day
Last modified on	2017 Year 07 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030214