UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Associations of the velocity of superior thyroid artery with thyroid diseases and psychiatric disorders
Title of the study (Brief title)	Associations of the velocity of superior thyroid artery with thyroid diseases and psychiatric disorders
Region	Japan

Condition
Condition	hyperthyroidism/thyrotoxicosis and mental disorders
Classification by specialty	Medicine in general Endocrinology and Metabolism Psychosomatic Internal Medicine Psychiatry Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the clinical feasibility of measuring peak systolic velocity of superior thyroid artery (STA-PSV) for differential diagnosis of hyperthyroidism/thyrotoxicosis, and the differences in STA-PSV between patients with and without mental disorders (MD).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Thyroid volume(length,width,depth),STA-PSV,clinical diagnosis of thyroid diseases
Key secondary outcomes	Age,sex,height,weight,BMI,blood pressure,TSH,FT3,FT4,autoantibodies(TRAb,TSAb,TgAb,TPOAb),thyroglobulin,with and without MD,clinical diagnosis of MD

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	Among subjects who had undergone a thyroid ultrasonography between April 2013 and November 2016 at National Center for Global Health and Medicine Kohnodai Hospital, Chiba, Japan.
Key exclusion criteria	Subjects who were younger than 20 years, had a thyroid cancer, and received a radioiodine therapy or surgical therapy.
Target sample size	700

Research contact person
Name of lead principal investigator	Marino Morikawa, Yanai Hidekatsu
Organization	National Center for Global Health and Medicine Kohnodai Hospital
Division name	Department of Internal Medicine.
Address	kohnodai1-7-1,Itikawa-City,Chiba,Japan
TEL	047-372-3501
Email	dyanai@hospk.ncgm.go.jp

Public contact
Name of contact person	Marino Morikawa
Organization	National Center for Global Health and Medicine Kohnodai Hospital
Division name	Department of Internal Medicine
Address	kohnodai1-7-1,Itikawa-City,Chiba,Japan
TEL	047-372-3501
Homepage URL
Email	mmorikawa-kgw@umin.ac.jp

Sponsor
Institute	National Center for Global Health and Medicine Kohnodai Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	国立国際医療研究センター国府台病院

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 02 Month 16 Day
Anticipated trial start date	2017 Year 02 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Study Design: Cross-sectional study. Setting & Participants: Among subjects who had undergone a thyroid ultrasonography between April 2013 and November 2016.

Management information
Registered date	2017 Year 02 Month 22 Day
Last modified on	2018 Year 09 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028973