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

Not Applicable

• Conditions: Stroke, Dementia; Stroke, Intracerebral hemorrhage, microbleeds, lacunar stroke, vascular cognitive impairment; D020521, D003704, D020300, D015140, D000544

• Registration Number: JPRN-jRCT1050190051
• Lead Sponsor: Ihara Masafumi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-19
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 700

Inclusion 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.

Exclusion 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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stroke Cohort Study<br>Prevalence of Cnm-positive S. mutans in oral cavity (saliva and dental plaque) among subjects with stroke (ischemic stroke, or hemorrhagic stroke).<br><br>Dementia cohort<br>Prevalence of Cnm-positive S. mutans in oral cavity (saliva and dental plaque) in dementia (Alzheimer disease, vascular dementia, mixed type).

Secondary Outcome Measures

Name	Time	Method
Stroke Cohort Study<br>The association between prevalence of Cnm-positive S. mutans in oral cavity and<br>the location of ICH (lobar, deep, mixed).<br>the estimated hematoma volume of ICH.<br><br>Dementia Cohort Study<br>The association between prevalence of Cnm-positive S. mutans in oral cavity and<br>Small vessel disease biomarkers on MRI (white matter lesion, lacunar infarctions, cerebral microbleeds, enlargement of perivascular space) and atrophic change in hippocampus. <br>score of Montreal Cognitive Assessment (MoCA), Minimental State Examination (MMSE) <br>self-reported dental disorder and number of naturally remaining teeth.