UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026309
Receipt number R000030214
Scientific Title A retrospective observational study of the risk factors for abdominal aortic aneurysm expansion
Date of disclosure of the study information 2017/02/26
Last modified on 2017/07/05 16:15:04

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Basic information

Public title

A retrospective observational study of the risk factors for abdominal aortic aneurysm expansion

Acronym

A retrospective observational study of the risk factors for abdominal aortic aneurysm expansion

Scientific Title

A retrospective observational study of the risk factors for abdominal aortic aneurysm expansion

Scientific Title:Acronym

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

1st name
Middle name
Last name Hitoshi Goto

Organization

Tohoku University Hospital

Division name

Department of Transplantation, Reconstruction and Endoscopic Surgery

Zip code


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

1st name
Middle name
Last name Yuta Tajima

Organization

Tohoku University Hospital

Division name

Department of Transplantation, Reconstruction and Endoscopic Surgery

Zip code


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 or person

Institute

Tohoku University Hospital

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://doi.org/10.1253/circj.CJ-16-0902

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

2017 Year 05 Month 01 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030214


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name