UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Correlation between periodontal bacteria and progression of aortic aneurysm
Title of the study (Brief title)	Correlation between periodontal bacteria and progression of aortic aneurysm
Region	Japan

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

Objectives
Narrative objectives1	To elucidate the effect of periodontal bacteria on the progression of aortic aneurysm by inspecting the specimens of aortic aneurysm surgery.
Basic objectives2	Others
Basic objectives -Others	observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Verification of the presence of periodontal bacteria in the aortic aneurysmal wall
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	patients who undergo open aortic aneurysm repair in our hospital
Key exclusion criteria	TEVAR case
Target sample size	30

Research contact person
Name of lead principal investigator	Yoshikatsu Saiki
Organization	Tohoku University Graduate School of Medicine
Division name	Cardiovascular surgery
Address	1-1, Seiryocho, Aobaku, Sendai, Japan
TEL	022-717-7222
Email	yoshisaiki@med.tohoku.ac.jp

Public contact
Name of contact person	Kiichiro Kumagai
Organization	Tohoku University Graduate School of Medicine
Division name	Cardiovascular surgery
Address	1-1, Seiryocho, Aobaku, Sendai, Japan
TEL	022-717-7000
Homepage URL
Email	kkumagai@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	2016 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 06 Month 22 Day
Anticipated trial start date	2016 Year 04 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	Unpublished
URL releasing results
Results
Other related information	plan to analyze in PCR or culture

Management information
Registered date	2015 Year 07 Month 31 Day
Last modified on	2019 Year 02 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021391