UMIN-CTR Clinical Trial

Basic information
Public title	Prospective study on thyroid function before and after mechanical thrombectomy
Acronym	Prospective study on thyroid function before and after mechanical thrombectomy
Scientific Title	Prospective study on thyroid function before and after mechanical thrombectomy
Scientific Title:Acronym	Prospective study on thyroid function before and after mechanical thrombectomy
Region	Japan

Condition
Condition	stroke, cerebral infarction
Classification by specialty	Medicine in general Endocrinology and Metabolism Neurology Neurosurgery Emergency medicine Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to be clear the presence of the Wolff-Chaikoff phenomenon after mechanical thrombectomy.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The values of TSH, T3, T4 before and after mechanical thrombectomy
Key secondary outcomes	consciousness of patients

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	110 years-old >=
Gender	Male and Female
Key inclusion criteria	The patients operated with mechanical thrombectomy and had given consent to participate (the patient or the agent).
Key exclusion criteria	Patients judged to be inappropriate to be include in this study by two doctors
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Yuya Middle name Last name Kobayashi
Organization	Ina Central Hospital
Division name	Department of Neurology
Zip code	3968555
Address	koshirokubo1313-1, ina, nagano
TEL	0265723121
Email	juriruri@inahp.jp

Public contact
Name of contact person	1st name Yuya Middle name Last name Kobayashi
Organization	Ina Central Hospital
Division name	Department of Neurology
Zip code	3968555
Address	koshirokubo1313-1, ina, nagano
TEL	0265723121
Homepage URL
Email	juriruri@inahp.jp

Sponsor
Institute	Ina Central Hospital
Institute
Department

Funding Source
Organization	Ina Central Hospital
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	Ina Central Hospital
Address	koshirokubo1313-1, ina, nagano
Tel	0265723121
Email	juriruri@inahp.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	2020 Year 06 Month 17 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	Completed
Date of protocol fixation	2020 Year 06 Month 17 Day
Date of IRB	2020 Year 06 Month 17 Day
Anticipated trial start date	2020 Year 03 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2022 Year 06 Month 07 Day
Date analysis concluded	2022 Year 06 Month 07 Day

Other
Other related information	none

Management information
Registered date	2020 Year 06 Month 17 Day
Last modified on	2022 Year 06 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046592