UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039512
Receipt number R000045059
Scientific Title A study of clinical usefulness of vascular function.
Date of disclosure of the study information 2020/02/17
Last modified on 2022/08/29 14:45:57

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Basic information

Public title

A study of clinical usefulness of vascular function.

Acronym

A study of clinical usefulness of vascular function.

Scientific Title

A study of clinical usefulness of vascular function.

Scientific Title:Acronym

A study of clinical usefulness of vascular function.

Region

Japan


Condition

Condition

atherosclerosis

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objective of this study is to evaluate the association between vascular function and risk factors.

Basic objectives2

Others

Basic objectives -Others

The objective of this study is to evaluate the association between vascular function and risk factors.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

PWV,FMD,ezFMD,NID,IMT,RHI,arterial diameter,ROCK activity,EPC

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who underwent vascular function examinations at Hiroshima University Hospital

Key exclusion criteria

Are considered not eligible for the study by the attending doctor due to other reasons

Target sample size

10000


Research contact person

Name of lead principal investigator

1st name Yukihito
Middle name
Last name Hagashi

Organization

Hiroshima University Hospital

Division name

Medical Center for Translational and Clinical Research

Zip code

734-8553

Address

1-2-3 Kasumi, Minamiku, Hiroshima

TEL

082-257-5831

Email

yhigashi@hiroshima-u.ac.jpjp


Public contact

Name of contact person

1st name Yukihito
Middle name
Last name Higashi

Organization

Hiroshima University Hospital

Division name

Medical Center for Translational and Clinical Research

Zip code

734-8553

Address

1-2-3 Kasumi, Minamiku, Hiroshima

TEL

082-257-5831

Homepage URL


Email

yhigashi@hiroshima-u.ac.jp


Sponsor or person

Institute

Hiroshima University Hospital

Institute

Department

Personal name



Funding Source

Organization

Self-procurement

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

the ethical committees of Hiroshima University

Address

1-2-3 Kasumi, Minamiku, Hiroshima

Tel

082-257-1752

Email

protocol@cimr.hiroshima-u.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

2020 Year 02 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

Open public recruiting

Date of protocol fixation

2020 Year 02 Month 05 Day

Date of IRB

2020 Year 02 Month 05 Day

Anticipated trial start date

2000 Year 01 Month 01 Day

Last follow-up date

2027 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

vascular function and risk factors


Management information

Registered date

2020 Year 02 Month 17 Day

Last modified on

2022 Year 08 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045059


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name