UMIN-CTR Clinical Trial

Public title

Search for new markers in acute stroke using microRNA in blood

Acronym

Search for new markers in acute stroke using microRNA in blood

Scientific Title

Search for new markers in acute stroke using microRNA in blood

Scientific Title:Acronym

Search for new markers in acute stroke using microRNA in blood

Region

Japan

Condition

Stroke

Classification by specialty

Medicine in general

Neurology

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

Measure blood microRNA and blood clot microRNA obtained by collecting blood clots as biomarkers for stroke patients, and examine the role of microRNAs and their usefulness as biomarkers.Blood microRNA is also measured from controls who have not developed a stroke.Using the neutrophil activity evaluation system, the activity state of neutrophils is also measured at the same time.

Basic objectives2

Others

Basic objectives -Others

none

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Establish a simple marker such as troponin T in myocardial infarction in cerebral infarction and cerebral hemorrhage

Key secondary outcomes

Establish severity markers from quantitative results
Consider what changes occur in the body from miRNA profiles
Collect thrombus clogged in the brain due to cardiogenic cerebral embolism and examine miRNA in the thrombus
Is neutrophil activity different depending on the type and timing of stroke?
Is miRNA related to neutrophil activity?

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

20

years-old

<=

Age-upper limit

85

years-old

>=

Gender

Male and Female

Key inclusion criteria

Stroke group (onset within 1 week): 250 cases
Control group (no history of stroke): 250 cases

Key exclusion criteria

Patients who cannot obtain the consent of the person and the blood relative (within first degree)
Other patients judged by researchers as inappropriate

Target sample size

500

Name of lead principal investigator

1st name	ARATA
Middle name
Last name	ABE

Organization

Tokyo Metropolitan Tama Medical Center

Division name

Department of Neurology and Stroke Medicine

Zip code

183-8524

Address

2-8-29 Musashidai, Fuchu City, Tokyo, Japan

TEL

+81-42-323-5111

Email

abe@nms.ac.jp

Name of contact person

1st name	Emiko
Middle name
Last name	Koba

Organization

Tokyo Metropolitan Tama Medical Center

Division name

Clinical Research Department

Zip code

183-8524

Address

2-8-29 Musashidai, Fuchu City, Tokyo, Japan

TEL

+81-42-323-5111

Homepage URL

Email

tamarinshou@tmhp.jp

Institute

Tokyo Metropolitan Tama Medical Center

Institute

Department

Personal name

Organization

Tokyo Metropolitan Tama Medical Center

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Tokyo Metropolitan Tama Medical Center

Address

2-8-29 Musashidai, Fuchu City, Tokyo, Japan

Tel

+81-42-323-5111

Email

Yuuko_Hachisu@member.metro.tokyo.jp

Secondary IDs

YES

Study ID_1

30-40

Org. issuing International ID_1

Tokyo Metropolitan Tama Medical Center

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2019

Year

11

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

280

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

Terminated

Date of protocol fixation

2018

Year

06

Month

11

Day

Date of IRB

2018

Year

06

Month

11

Day

Anticipated trial start date

2018

Year

06

Month

12

Day

Last follow-up date

2019

Year

05

Month

31

Day

Date of closure to data entry

2019

Year

05

Month

31

Day

Date trial data considered complete

Date analysis concluded

Other related information

Registered patients listen to medical history at the first visit and hospitalization, and perform general blood tests, ultrasonography, and head MRI. In this study, extra blood is used for blood tests for medical purposes (performed in the blood collection room) at regular or irregular intervals.
Procedure
1 Obtain patient explanation and consent
2 After taking a blood test, go to the laboratory to take a blood sample
3 Treat whole blood (1-2 mL of residual blood) collected in EDTA-2K blood collection tube within 2 hours.
4 Put 1mL of whole blood into a tube containing 1mL of RNase-free water and 6mL of TRIzol LS Reagent.
5 Stir vigorously and store frozen at -80 degrees.
6 When the number of specimens has increased to some extent, contact the analysis organization to have the specimens picked up and handed over. A very small amount of blood is collected from the fingertip of a registered patient who has obtained consent using a needle for blood glucose measurement. In this study, although it is invasive, blood is collected according to the conventional procedure for blood glucose measurement, so there is no excessive invasion.

Registered date

2019

Year

10

Month

17

Day

Last modified on

2020

Year

05

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043672