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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000038321
Receipt No. R000043672
Scientific Title Search for new markers in acute stroke using microRNA in blood
Date of disclosure of the study information 2019/11/01
Last modified on 2019/10/17

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Basic information
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
Condition Stroke
Classification by specialty
Medicine in general Neurology
Classification by malignancy Others
Genomic information YES

Objectives
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

Assessment
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?

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
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

Research contact person
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

Public contact
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

Sponsor
Institute Tokyo Metropolitan Tama Medical Center
Institute
Department

Funding Source
Organization Tokyo Metropolitan Tama Medical Center
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
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
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
Institutions

Other administrative information
Date of disclosure of the study information
2019 Year 11 Month 01 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 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

Progress
Recruitment status No longer recruiting
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
Date trial data considered complete
Date analysis concluded

Other
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.

Management information
Registered date
2019 Year 10 Month 17 Day
Last modified on
2019 Year 10 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043672

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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