UMIN-CTR Clinical Trial

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	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

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	2020 Year 05 Month 12 Day

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