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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038137
Receipt No. 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

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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
Email 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
Email tonomura.shuichi58@ncvc.go.jp

Sponsor
Institute Department of Neurology, National Cerebral and Cardiovascular Center
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043460

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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