UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024251 |
|---|---|
| Receipt number | 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 | 2020/04/04 14:02:35 |
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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 | Akihisa |
| Middle name | |
| Last name | Kataoka |
Organization
Teikyo University
Division name
Department of Medicine
Zip code
173-8606
Address
2-11-1 Kaga, Itabashi-ku, Tokyo 173-8606, Japan
TEL
+81-3-3964-1211
kataoaki@sd5.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Akihisa |
| Middle name | |
| Last name | Kataoka |
Organization
Teikyo University
Division name
Department of Medicine
Zip code
173-8606
Address
2-11-1 Kaga, Itabashi-ku, Tokyo 173-8606, Japan
TEL
+81-3-3964-1211
Homepage URL
kataoaki@sd5.so-net.ne.jp
Sponsor or person
Institute
Teikyo University
Institute
Department
Personal name
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
Research Ethics Committee, Faculty of Medicine, Teikyo University
Address
2-11-1 Kaga, Itabashi-ku, Tokyo 173-8606, Japan
Tel
03-3964-7256
turb-office@teikyo-u.ac.jp
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
Completed
Date of protocol fixation
| 2016 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
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
| 2020 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027886
