UMIN-CTR Clinical Trial

Basic information
Public title	Relation between Achilles tendon thickness as one of diagnostic criteria of Familial Hypercholesterolemia and cardiovascular, atherosclerotic diseases
Acronym	Relation between Achilles tendon thickness and cardiovascular, atherosclerotic diseases
Scientific Title	Relation between Achilles tendon thickness as one of diagnostic criteria of Familial Hypercholesterolemia and cardiovascular, atherosclerotic diseases
Scientific Title:Acronym	Relation between Achilles tendon thickness and cardiovascular, atherosclerotic diseases
Region	Japan

Condition
Condition	atherosclerotic and cardiovascular diseases
Classification by specialty	Medicine in general Cardiology Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We intended to evaluate the relation between Achilles tendon thickness as one of diagnostic criteria of Familial Hypercholesterolemia and cardiovascular, atherosclerotic diseases.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	cardiovascular, atherosclerotic diseases
Key secondary outcomes	Examinations of cardiovascular, atherosclerotic diseases

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients visited my hospital because of some symptoms and/or medical check-up about cardiovascular, atherosclerotic diseases
Key exclusion criteria	Patients who did not agree with examination(s).
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Nobukiyo Middle name Last name Tanaka
Organization	Ichinomiya Nishi Hospital
Division name	Department of Cardiovascular Medicine
Zip code	4940001
Address	Ichinomiya, Japan
TEL	0586-48-0077
Email	nobukiyo282000@yahoo.co.jp

Public contact
Name of contact person	1st name Nobukiyo Middle name Last name Tanaka
Organization	Ichinomiya Nishi Hospital
Division name	Department of Cardiovascular Medicine
Zip code	4940001
Address	Ichinomiya, Japan
TEL	0586-48-0077
Homepage URL
Email	nobukiyo282000@yahoo.co.jp

Sponsor
Institute	Ichinomiya Nishi Hospital
Institute
Department

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

Other related organizations
Co-sponsor	None
Name of secondary funder(s)	None

IRB Contact (For public release)
Organization	Ichinomiya Nishi Hospital
Address	Kaimei Hira 1
Tel	0586480077
Email	nobukiyo282000@yahoo.co.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	一宮西病院（愛知県）　 Ichinomiya Nishi Hospital(Ichinomiya-City,Aichi-pref.)

Other administrative information
Date of disclosure of the study information	2014 Year 06 Month 11 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	Enrolling by invitation
Date of protocol fixation	2010 Year 04 Month 01 Day
Date of IRB	2010 Year 04 Month 01 Day
Anticipated trial start date	2010 Year 04 Month 01 Day
Last follow-up date	2030 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	observation study The relation between Achilles tendon thickness as one of diagnostic criteria of Familial Hypercholesterolemia and cardiovascular, atherosclerotic diseases.

Management information
Registered date	2014 Year 06 Month 10 Day
Last modified on	2021 Year 12 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016446