UMIN-CTR Clinical Trial

Basic information
Public title	Endothelial Function Study
Acronym	Endothelial Function Study
Scientific Title	Endothelial Function Study
Scientific Title:Acronym	Endothelial Function Study
Region	Japan

Condition
Condition	Cardiovascular disease, Hypertension, Diabetes mellitus, Dyslipidemia, Subjects with coronary risk factors, healthy subjects
Classification by specialty	Medicine in general Cardiology Vascular surgery Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to evaluate 1) endothelial function in ardiovascular disease, Hypertension, Diabetes mellitus, Dyslipidemia, Subjects with coronary risk factors, and healthy subjects, 2) the effects of pharmacological interventions on endothelial function
Basic objectives2	Others
Basic objectives -Others	The purpose of this study was to evaluate role of endothelial function in cardiovascular outcomes.
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	endothelial function
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Endothelial function
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	18 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with cardiovascular diseases, hypertension, diabetes mellitus, dyslipidemia and subjects with coronary risk factors are enrolled in this study.
Key exclusion criteria	Subjects who were not able to be obtained written informed consent for participation were excluded in this study.
Target sample size	10000

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yukihito Higashi
Organization	Hiroshima University Hospital
Division name	Division of Regenerative Medicine
Zip code
Address	1-2-3 Kasumi, Minamiku, Hiroshima
TEL	082-257-5122
Email

Public contact
Name of contact person	1st name Middle name Last name Yukihito Higashi
Organization	Hiroshima university Hospital
Division name	Division of Regenerative Medicine
Zip code
Address	1-2-3 kasumi, minamiku, hiroshima
TEL	082-257-5122
Homepage URL	http://home.hiroshima-u.ac.jp/angio/
Email	yhigashi@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University
Institute
Department

Funding Source
Organization	This study was supported in part by a Grant-in-Aid for Scientific Research from the Ministry of Education, Science and Culture of Japan (1859081500 and 21590898).
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2010 Year 06 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	Open public recruiting
Date of protocol fixation	1998 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date	1998 Year 07 Month 01 Day
Last follow-up date	2017 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2010 Year 06 Month 15 Day
Last modified on	2010 Year 06 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004554

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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