UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010404 |
|---|---|
| Receipt number | 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 19:49:52 |
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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
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
m-kimata@sis.seirei.or.jp
Sponsor or person
Institute
Department of Neurosurgery, Seirei Hamamatsu General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012168
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