UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	epidemiologic research about prognosis of Abdominal aortic aneurysm and iliac artery aneurysm Patients.
Title of the study (Brief title)	epidemiologic research about prognosis of AAA and IAA patients.
Region	Japan

Condition
Condition	Abdominal Aortic Aneurysm (AAA) Iliac Artery Aneurysm (IAA)
Classification by specialty	Vascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To reveal the appropriate follow up and surgical indication in the AAA and IAA patients in Asia by investigating the prognosis of them either after surgery or in natural course prospectively. Furthermore, to find a clue of nonoperative therapy by detecting risk factors of Aneurysm expansion and rupture,
Basic objectives2	Others
Basic objectives -Others	prospective observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	over all survival
Key secondary outcomes	Aneurysm rupture surgical complications reinterventions for aneurysm growth rate of aneurysm Morbidity rate of atherosclerotic cardiocascular diseases transitions of quality of life, activity of daily life and cognitive fuction medical expenses

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	Preoperative AAA and/or IAA patients who receive a medical examination at Tohoku University Hospital or affiliated hospitals. Patinets who understand this study and consent to join this study. 20 yeras of age or over.
Key exclusion criteria	Patines who do not consent to join this study. Under 20 years of age.
Target sample size	1000

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

Public contact
Name of contact person	Tajima Yuta
Organization	Tohoku University Hospital
Division name	Department of Transplantation, Reconstruction and Endoscopic Surgery
Address	1-1 Seiryo-cho, Aoba-ku, Sendai 980-8574, Japan
TEL	022-717-7214
Homepage URL
Email	yuta.tajima.a6@tohoku.ac.jp

Sponsor
Institute	Tohoku Universiity
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	2018 Year 01 Month 24 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 10 Month 01 Day
Anticipated trial start date	2018 Year 01 Month 25 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	Unpublished
URL releasing results
Results
Other related information	Preinitiation

Management information
Registered date	2018 Year 01 Month 24 Day
Last modified on	2018 Year 01 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035167