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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000024251
Receipt No. R000027886
Scientific Title Are Periodontal bacteRIa assoCiated with degenerative aOrtic sTenosis as a new risk factor? - APRICOT study
Date of disclosure of the study information 2016/11/01
Last modified on 2016/10/01

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Basic information
Public title Are Periodontal bacteRIa assoCiated with
degenerative aOrtic sTenosis as a new risk factor? - APRICOT study
Acronym APRICOT study
Scientific Title Are Periodontal bacteRIa assoCiated with
degenerative aOrtic sTenosis as a new risk factor? - APRICOT study
Scientific Title:Acronym APRICOT study
Region
Japan

Condition
Condition aortic stenosis
Classification by specialty
Cardiology Dental medicine
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 to clarify that periodontal bacteria associate with the progeression of degenerative aortic stenosis
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes comparison between the biomarkers of periodontal bacteria in saliva and serum and the parameters of aortic stenosis by echocardiography
Key secondary outcomes comparison of the biomarkers of periodontal bacteria from exenterate aortic valve and aortic wall

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 outpatients or inpatients, who have aortic stenosis

Control: Patients who undergo aortic valve replacement due to severe aortic regartitation
Key exclusion criteria Patients from whom we cannot obtain the concent of this study
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihisa Kataoka
Organization Teikyo University
Division name Department of Medicine
Zip code
Address 2-11-1 Kaga, Itabashi-ku, Tokyo 173-8606, Japan
TEL +81-3-3964-1211
Email kataoaki@sd5.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akihisa Kataoka
Organization Teikyo University
Division name Department of Medicine
Zip code
Address 2-11-1 Kaga, Itabashi-ku, Tokyo 173-8606, Japan
TEL +81-3-3964-1211
Homepage URL
Email kataoaki@sd5.so-net.ne.jp

Sponsor
Institute Teikyo University
Institute
Department

Funding Source
Organization Tokyo Medical and Dental University
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
2016 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
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
Date of protocol fixation
2016 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 10 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 Study design: observation study

Study (enrolment) duration: Oct 1, 2016 to Mar 31, 2018

Object recruitment:
patients with aortic stenosis who visit or admit to Teikyo university hospital and meet the selection criteria

Observation item:
-PCR data of periodontal bacteria from saliva, aortic valve, or aortic wall

-antibody titers of periodontal bacteria obtained from the serum using ELISA method

-aortic stenosis parameters by echocardiography in clinical settings

-RNA-seq and immunostaining of exenterate aortic valve and aortic wall

Management information
Registered date
2016 Year 10 Month 01 Day
Last modified on
2016 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027886

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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