UMIN-CTR Clinical Trial

Public title

Risk Assessment of cnM-positivE S. mutans in StrokE Survivors

Acronym

RAMESSES study

Scientific Title

Risk Assessment of cnM-positivE S. mutans in StrokE Survivors: The multicenter prospective cohort study

Scientific Title:Acronym

RAMESSES study

Region

Japan

Condition

Stroke

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To explore whether cnm-positive S.
mutans associated with the new development of cerebral microbleeds (CMBs)

Basic objectives2

Others

Basic objectives -Others

To explore whether cnm-positive S.
mutans associated with stroke or vascular cognitive impairment

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

(1) newly developed deep CMBs

Key secondary outcomes

1) newly developed lobar or subtentorial CMBs;
2) development of symptomatic intracerebral hemorrhage or ischemic stroke;
3) change in cognitive function assessed by Montreal cognitive assessment (MoCA) and clinical dementia rating;
4) major bleeding defined by the International Society on Thrombosis and Hemostasis criteria;
5) all-cause mortality; and
6) serum antibody titers against periodontal pathogens

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

40

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) patients with stroke (cerebral infarction, intracerebral hemorrhage, subarachnoid hemorrhage) or transient ischemic attack that is developed within 365 days at the time of acquiring written informed consent;
2) patients over 40 years old;
3) patients whose modified Rankin Scale is 4 or less at the time of acquiring consent;
4) patients who have deep ICH or at least 1 deep CMBs on T2*WI in the head MRI performed within 365 days from acquiring consent;
5) the written informed consent has been obtained by the patients themselves or the proxies

Key exclusion criteria

1) patients who are contraindicated to MRI examination because of the presence of some metallic implants such as pacemaker devices;
2) patients who has hemorrhagic factors;
3) patients who participate in other intervention trials;
4) patients who cannot conduct MoCA due to severe dementia, deafness or visual impairment;
5) patients who has no remaining teeth;
6) patients whose participation are judged as inappropriate by the principal investigator or sub-investigators

Target sample size

230

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, Kishibe-Shimmachi, Suita, Osaka

TEL

06-6170-1070

Email

ihara@ncvc.go.jp

Name of contact person

1st name	Yorito
Middle name
Last name	Hattori

Organization

National Cerebral and Cardiovascular Center

Division name

Department of Neurology

Zip code

564-8565

Address

6-1, Kishibe-Shimmachi, Suita, Osaka

TEL

06-6170-1070

Homepage URL

Email

yoh2019@ncvc.go.jp

Institute

National Cerebral and Cardiovascular Center

Institute

Department

Personal name

Organization

Bristol-Myers Squibb Company

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

the Institutional Review Board at the National Cerebral and Cardiovascular Center

Address

6-1, Kishibe-Shimmachi, Suita, Osaka

Tel

06-6170-1070

Email

rec-office-ac@ncvc.go.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

国立循環器病研究センター（大阪府）
京都大学医学部附属病院（京都府）
滋賀医科大学医学部附属病院（滋賀県）
新潟大学脳研究所（新潟県）
京都府立医科大学附属病院（京都府）
広島大学医学部附属病院（広島県）
京都医療センター（京都府）
神戸大学医学部附属病院（兵庫県）
奈良県立医科大学附属病院（奈良県）
三重大学医学部附属病院（三重県）
東京歯科大学市川総合病院（千葉県）
医療法人 知音会 御池クリニック（京都府）
北野病院（大阪府）
神戸市立医療センター中央市民病院（兵庫県）
大阪医療センター（大阪府）
岐阜大学医学部附属病院（岐阜県）

Date of disclosure of the study information

2021

Year

09

Month

24

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2018

Year

01

Month

26

Day

Date of IRB

2018

Year

01

Month

26

Day

Anticipated trial start date

2018

Year

11

Month

01

Day

Last follow-up date

2024

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

The primary outcome is number of newly developed deep CMBs. The secondary outcomes are as follows; newly developed any, lobar or subtentorial CMBs, symptomatic intracerebral hemorrhage or ischemic stroke, change in cognitive function or frailty, development of major bleeding, all-cause mortality, and antibody titers against periodontal pathogens. We will observe them for two years longitudinally.

Registered date

2021

Year

09

Month

24

Day

Last modified on

2022

Year

09

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051416