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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010404
Receipt No. R000012168
Scientific Title A study comparing carriage rate difference of collagen binding protein (Cnm) positive S. mutans in saliva between patients with ruptured intracranial aneurysms and those with unruptured, to confirm whether it is a risk factor of intracranial aneurysmal rupture. Multi-center retrospective observation study.
Date of disclosure of the study information 2013/05/01
Last modified on 2020/10/14

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Basic information
Public title A study comparing carriage rate difference of collagen binding protein (Cnm) positive S. mutans in saliva between patients with ruptured intracranial aneurysms and those with unruptured, to confirm whether it is a risk factor of intracranial aneurysmal rupture. Multi-center retrospective observation study.
Acronym Shizuoka Saliva Streptococcus mutans Stroke Study for subarachnoid hemorrhage (5S for SAH)
Scientific Title A study comparing carriage rate difference of collagen binding protein (Cnm) positive S. mutans in saliva between patients with ruptured intracranial aneurysms and those with unruptured, to confirm whether it is a risk factor of intracranial aneurysmal rupture. Multi-center retrospective observation study.
Scientific Title:Acronym Shizuoka Saliva Streptococcus mutans Stroke Study for subarachnoid hemorrhage (5S for SAH)
Region
Japan

Condition
Condition intracranial aneurysm
Classification by specialty
Neurosurgery Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm whether collagen binding protein (Cnm) positive Streptococcus mutans in saliva is a risk factor of intracranial aneurysmal rupture
Basic objectives2 Others
Basic objectives -Others A study to confirm Cnm positive S. mutans as a risk factor of intracranial aneurysmal rupture
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes To confirm carriage rate of these bacteria in ruptured intracranial aneurysmal patients is statistically higher than that of unruptured intracranial aneurysmal patients.
Key secondary outcomes Relationship to the follwing items with Cnm positive S. mutans;
1. past history, complication, and known risk factors.
2. aneurysmal site, shape, and size.
3. other items in the survey sheets.

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 Ruptured aneurysms: Berry aneurysms diagnosed as the cause of subarachnoid hemorrhage.
Unruptured aneurysms: Berry aneurysms more than 3 mm in largest diameter, some part of aneurysmal wall must exist in subarachnoid space.
With written informed consent.
Should be diagnosed as board certified neurosurgeons or neuroradiologists.
Unruptured aneurysms associated with ruptured one should be classified as those with ruptured one.
Key exclusion criteria Within two months after antibiotics usage.
Aneurysms associated with bacterial endocarditis.
Dissecting cerebral aneurysms.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Tokutaro
Middle name
Last name Tanaka
Organization Seirei Hamamatsu General Hospital
Division name Dept. of Neurosurgery
Zip code 430-8558
Address 2-12-12 Sumiyoshi, naka-ku, Hamamatsu-City, Shizuoka-Prefecture, 430-8558 Japan
TEL 053-474-2222
Email asanoma@sis.seirei.or.jp

Public contact
Name of contact person
1st name Mitsuo
Middle name
Last name Kimata
Organization Seirei Hamamatsu General Hospital
Division name General Clinical Reseach Center
Zip code 430-8558
Address 2-12-12 Sumiyoshi, naka-ku, Hamamatsu-City, Shizuoka-Prefecture, 430-8558 Japan
TEL 053-474-2222
Homepage URL
Email m-kimata@sis.seirei.or.jp

Sponsor
Institute Department of Neurosurgery, Seirei Hamamatsu General Hospital
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Seirei Hamamatsu General Hospital
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Pharmacology, Hamamatsu University School of Medicine
Department of Pediatric Dentistry, Osaka
University Graduate School of Dentistry
Seirei Christopher University
Name of secondary funder(s) Ministry of Education, Culture, Sports, Science and Technology

IRB Contact (For public release)
Organization Clinical research management center, Seirei Hamamatsu Hospital
Address 2-12-12 Sumiyoshi, naka-ku, Hamamatsu-City, Shizuoka-Prefecture, 430-8558 Japan
Tel 053-474-2222
Email m-kimata@sis.seirei.or.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 聖隷浜松病院 脳神経外科(静岡県)
浜松医科大学 脳神経外科(静岡県)
聖隷三方原病院 脳神経外科(静岡県)
浜松医療センター 脳神経外科(静岡県)
焼津市立総合病院 脳神経外科(静岡県)
静岡赤十字病院 脳神経外科(静岡県)
沼津市立病院 脳神経外科(静岡県)
聖隷沼津病院 脳神経外科(静岡県)
富士宮市立病院 脳神経外科(静岡県)
聖隷横浜病院 脳神経外科(神奈川県)
日本医科大学 脳神経外科(東京都)
日本医科大学 千葉北総病院(千葉県)
日本医科大学 多摩永山病院(東京都)
すずかけセントラル病院(静岡県)
聖隷健康サポートセンター Shizuoka(静岡県)
内山医院 (愛知県)
さわい医院(静岡県)
おおいし脳神経外科クリニック(静岡県)
杉原脳神経外科クリニック(静岡県)
すみや脳神経クリニック(静岡県)
さとうクリニック(静岡県)
山崎クリニック(静岡県)
富士脳障害研究所(静岡県)

Other administrative information
Date of disclosure of the study information
2013 Year 05 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 1021
Results From May, 2013 to June, 2018, we had 258 cases of acute ruptured intracranial aneurysms, 238 cases of chronic postoperative ruptured intracranial aneurysms, 420 cases of preoperative unruptured intracranial aneurysms, and 105 cases of postoperative unruptured aneurysms. We compared these ruptured cases with unruptured cases. We found no statistically significant difference with p=0.810.
Results date posted
2020 Year 10 Month 14 Day
Results Delayed
Delay expected
Results Delay Reason It took time to complete survey slips.
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 No longer recruiting
Date of protocol fixation
2013 Year 03 Month 19 Day
Date of IRB
2013 Year 03 Month 19 Day
Anticipated trial start date
2013 Year 05 Month 01 Day
Last follow-up date
2016 Year 10 Month 31 Day
Date of closure to data entry
2018 Year 12 Month 31 Day
Date trial data considered complete
2018 Year 12 Month 31 Day
Date analysis concluded
2021 Year 03 Month 31 Day

Other
Other related information A study comparing carriage rate difference of Cnm positive S. mutans in saliva between patients with ruptured intracranial aneurysms and those with unruptured, to confirm whether it is a risk factor of intracranial aneurysmal rupture. Multi-center retrospective observation study.

Management information
Registered date
2013 Year 04 Month 02 Day
Last modified on
2020 Year 10 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012168

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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