International Risk Assessment of Cnm-positive S. mutans in Stroke and Vascular Dementia Surveillance

JRCT ID: jRCT1050190051

Registered date:19/09/2019

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Stroke, Dementia
• Date of first enrollment: 19/09/2019
• Target sample size: 700
• Countries of recruitment: Nigeria,Japan,Kenya,Japan,Singapore,Japan
• Study type: Observational
• Intervention(s): no-intervention

Outcome(s)

Primary Outcome

Stroke Cohort Study
Prevalence of Cnm-positive S. mutans in oral cavity (saliva and dental plaque) among subjects with stroke (ischemic stroke, or hemorrhagic stroke).

Dementia cohort
Prevalence of Cnm-positive S. mutans in oral cavity (saliva and dental plaque) in dementia (Alzheimer disease, vascular dementia, mixed type).

Secondary Outcome

Stroke Cohort Study
The association between prevalence of Cnm-positive S. mutans in oral cavity and
the location of ICH (lobar, deep, mixed).
the estimated hematoma volume of ICH.

Dementia Cohort Study
The association between prevalence of Cnm-positive S. mutans in oral cavity and
Small vessel disease biomarkers on MRI (white matter lesion, lacunar infarctions, cerebral microbleeds, enlargement of perivascular space) and atrophic change in hippocampus.
score of Montreal Cognitive Assessment (MoCA), Minimental State Examination (MMSE)
self-reported dental disorder and number of naturally remaining teeth.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

Stroke Cohort Study
Subjects
age >= 18 years old
First Ever Stroke (within 5 years from the onset)
Diagnosis based on brain imaging (computed tomography or magnetic resonance imaging)
A written informed consent has been obtained from the subjects or relatives.

Dementia Cohort Study
Subjects
age 55-85 years old
modified Rankin Scale <= 3
0.5<= Clinical Dementia Rating<= 2.0
MMSE score <=23
Evaluation of 3.0 tesla brain MRI imaging within 5 years
A written informed consent has been obtained from the subjects or relatives.

Exclude criteria

Stroke Cohort Study
recurrent stroke
cases who are difficult to communicate due to unconsciousness
cases with no-natural remaining teeth
cases judged inappropriated by collaborators.

Dementia Cohort Study
prevalence of other systemic diseases that clearly affect cognitive function within 3 months
cases who are difficult to communicate due to unconsciousness
cases with no-natural remaining teeth
cases judged inappropriated by collaborators.

Related Information

• Primary Sponsor: Ihara Masafumi
• Secondary Sponsor: Nakano Kazuhiko
• Secondary ID(s): UMIN000038137,