UMIN-CTR Clinical Trial

Basic information
Public title	A prospective multicenter trial of clot pathology in acute stroke
Acronym	A prospective multicenter trial of clot pathology in acute stroke
Scientific Title	A prospective multicenter trial of clot pathology in acute stroke
Scientific Title:Acronym	A prospective multicenter trial of clot pathology in acute stroke
Region	Japan

Condition
Condition	acute ischemic stroke
Classification by specialty	Neurology Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We perform this study to make clear about embolic source in acute ischemic stroke by clot pathology
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	none
Key secondary outcomes

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	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Patients of over 20 years old 2.acute ischemic stroke 3.Research consent have been obtained in writing from the person or alternative person
Key exclusion criteria	Other than key inclusion criteria
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Nobuyuki Middle name Last name Sakai
Organization	Kobe City Medical Center General Hospital
Division name	Neurosurgery
Zip code	6500047
Address	2-1-1, Minatojimaminamimachi, Chuo-ku, Kobe-shi, Hyogo
TEL	0783024321
Email	n.sakai@siren.ocn.ne.jp

Public contact
Name of contact person	1st name Takeihro Middle name Last name Katano
Organization	Nippon Medical School Hospital
Division name	Neurology
Zip code	1138603
Address	Bunkyouku, Sengdagi, 1-1-5
TEL	0338222131
Homepage URL
Email	t-katano@nms.ac.jp

Sponsor
Institute	Kyoto University Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Nippon Medical School Hospital Neurology
Address	Bunkyouku Sengagi 1-1-5
Tel	03383222131
Email	t-katano@nms.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
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 02 Month 15 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
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	Preinitiation
Date of protocol fixation	2018 Year 11 Month 30 Day
Date of IRB	2019 Year 01 Month 01 Day
Anticipated trial start date	2019 Year 01 Month 01 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observation examination

Management information
Registered date	2019 Year 01 Month 30 Day
Last modified on	2021 Year 08 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040687