UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038137 |
|---|---|
| Receipt number | R000043460 |
| Scientific Title | International Risk Assessment of Cnm-positive S. mutans in Stroke and Vascular Dementia Surveillance |
| Date of disclosure of the study information | 2019/09/28 |
| Last modified on | 2020/07/23 09:12:37 |
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Basic information
Public title
International Risk Assessment of Cnm-positive S. mutans in Stroke and Vascular Dementia Surveillance
Acronym
International-RAMESSES trial
Scientific Title
International Risk Assessment of Cnm-positive S. mutans in Stroke and Vascular Dementia Surveillance
Scientific Title:Acronym
International-RAMESSES trial
Region
| Japan | Asia(except Japan) | Africa |
Condition
Condition
stroke, intracerebral hemorrhage, cerebral microbleeds, lacunar stroke, dementia, Alzheimer's dementia, vascular dementia
Classification by specialty
| Neurology | Infectious disease | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Recently, we proposed the novel concept, Brain-Oral Axis, focusing on the specific strain of cariogenic bacteria, Streptococcus mutans expressing collagen-binding protein Cnm (Cnm+ S. mutans) as underlying mechanism of spontaneous intracerebral hemorrhage (sICH), hemorrhagic small vessel diseases (SVDs), and vascular dementia in both experimental and cohort studies held in Japan. However, there are few available data of other Asian and African countries, where the global burden of ICH was increased in recent two decades. In this international collaboration study, we aimed to research the relationship between oral microbiota and stroke or dementia.
Basic objectives2
Others
Basic objectives -Others
exploratory research
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Stroke Cohort Study: Prevalence of Cnm+ S. mutans in the oral cavity (saliva and dental plaque) among subjects with stroke (ischemic stroke, or hemorrhagic stroke).
Dementia Cohort Study: Prevalence of Cnm+ S. mutans in the oral cavity (saliva and dental plaque) in dementia (Alzheimer disease, vascular dementia, mixed type).
Key secondary outcomes
The association between prevalence of Cnm+ S. mutans in oral cavity and
1. self-reported dental health and number of naturally remaining teeth in eath ethnicity.
2. the location of ICH (lobar, deep, or mixed) in the stroke cohort study.
3. the estimated hematoma volume of ICH in the stroke cohort study
4. SVD markers on brain MRI (White matter hyperintensity, lacunar infarction, cerebral microbleeds, enlargement of perivascular space) and hippocampus atrophy in the dementia cohort study.
5. the score of Montreal Cognitive Assessment (MoCA) and Mini Mental State Examination (MMSE) in the dementia cohort study.
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Stroke Cohort Study
Subjects
1. 85>= age >= 18 years old
2. First Ever Stroke (within 5 years from the onset)
3. Diagnosis based on brain imaging (computed tomography or magnetic resonance imaging)
4. A written informed consent has been obtained from the subjects or relatives
Dementia Cohort Study
Subjects
1. 88>= age >= 55 years old
2. modified Rankin Scale <= 3
3. 0.5<= Clinical Dementia Rating <= 2.0
4. MMSE score <23
5. Evaluation of 3.0 tesla brain MRI imag ing within 5 years
6. A written informed consent has been obtained from the subhects or relatives
Key exclusion criteria
1. case with no natural remaining teeth
2. case who are difficult to communicate due to unconsciousness
3. case judged inappropriate by researchers by any other reason
Stroke Cohort Study
4. case with recurrent stroke
Dementia Cohort Study
4. cases who suffered other systemic diseases that clearly affect cognitive function within 3 months.
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Ihara |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Neurology
Zip code
564-8565
Address
6-1, Shimmachi, Kishibe, Suita, Osaka
TEL
06-6170-1070
ihara@ncvc.go.jp
Public contact
Name of contact person
| 1st name | Shuichi |
| Middle name | |
| Last name | Tonomura |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Neurology
Zip code
564-8565
Address
6-1, Shimmachi, Kishibe, Suita, Osaka
TEL
06-6170-1070
Homepage URL
tonomura.shuichi58@ncvc.go.jp
Sponsor or person
Institute
Department of Neurology, National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research (B)
Grant-in-Aid for Challenging Exploratory Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Division of Oral Infection and Disease Control, Osaka University Graduate School of Dentistry, Osaka, Japan.
Department of Human Anatomy, University of Nairobi, Kenya.
Department of Medicine, Federal Medical Centre, Abeokuta, Nigeria.
Institute for Advanced Medical Research and Training, College of Medicine, University of Ibadan, Ibadan, Nigeria.
Memory Aging and Cognition Centre, National University Health System, Singapore, Singapore
Department of Neurology, Alkhairaat University, Palu, Central Sulawesi, Indonesia
Name of secondary funder(s)
The OHYAMA health Foundation
The NOVARTIS Foundation for the Promotion of Science, Japan
The Japan Heart Foundation, Japan
The Smoking Research Foundation, Japan
Oyama health foundation, Japan
IRB Contact (For public release)
Organization
National Cerebral and Cardiovascular Center
Address
6-1, Shimmachi, Kishibe, Suita, Osaka
Tel
06-6170-1070
rec-office-ac@ncvc.go.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
jRCT1050190051
Org. issuing International ID_1
National Institute of Public Health, Japan
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国立循環器病研究センター（大阪府）、大阪大学大学院歯学研究科（大阪府）、Department of Human Anatomy, University of Nairobi(Nairobi, Kenya)、Department of Medicine, Kenyatta National Hospital (Nairobi, Kenya)、Department of Medicine, Federal Medical Centre (Abeokuta, Nigeria)、Institute for Advanced Medical Research and Training, College of Medicine, University of Ibadan (Ibadan, Nigeria)、Memory Aging and Cognition Centre, National University Health System, (Singapore, Singapore)、Hassanuddin University（Makassar, Indonesia)、Philippine General Hospital(Philippine）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 28 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 08 | Month | 14 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2019 | Year | 09 | Month | 27 | Day |
Last modified on
| 2020 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043460
