UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036722
Receipt number R000041841
Scientific Title Examination about correlation between Muscle sympathetic nerve activity and Arterial Pressure volume Index(API) , or Arterial Velocity pulse Index(AVI)
Date of disclosure of the study information 2019/05/13
Last modified on 2019/05/13 01:35:19

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Basic information

Public title

Examination about correlation between Muscle sympathetic nerve activity and Arterial Pressure volume Index(API) , or Arterial Velocity pulse Index(AVI)

Acronym

Examination about correlation between Muscle sympathetic nerve activity and Arterial Pressure volume Index(API) , or Arterial Velocity pulse Index(AVI)

Scientific Title

Examination about correlation between Muscle sympathetic nerve activity and Arterial Pressure volume Index(API) , or Arterial Velocity pulse Index(AVI)

Scientific Title:Acronym

Examination about correlation between Muscle sympathetic nerve activity and Arterial Pressure volume Index(API) , or Arterial Velocity pulse Index(AVI)

Region

Japan


Condition

Condition

Healthy,Hypertension

Classification by specialty

Medicine in general Cardiology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In this study, we examinated about correlation between Muscle sympathetic nerve activity and Arterial stiffness

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

API,AVI,MSNA

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

20 years-old <

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Healthy or hypertensive subjects

Key exclusion criteria

Patients with an estimated glomerular filtration rate of <50ml/min/1.73m2, advanced lung disease, mental illness, severe hepatic dysfunction, severe diabetes, neurological disease, maintenance dialysis.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Hiroyuki
Middle name
Last name Sugimoto

Organization

Kanazawa University

Division name

Cardiology

Zip code

920-0934

Address

Kanazawa city Takara prefecture

TEL

076-265-2000

Email

sugisugisugisugi5@gmail.com


Public contact

Name of contact person

1st name Hiroyuki
Middle name
Last name Sugimoto

Organization

Kanazawa University

Division name

Cardiology

Zip code

920-0934

Address

Kanazawa city Takara prefecture

TEL

076-265-2000

Homepage URL


Email

sugisugisugisugi5@gmail.com


Sponsor or person

Institute

Kanazawa University

Institute

Department

Personal name



Funding Source

Organization

Kanazawa University

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nothing

Address

Nothing

Tel

Nothing

Email

Nothing


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

2019 Year 05 Month 13 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

2017 Year 04 Month 01 Day

Date of IRB

2018 Year 10 Month 17 Day

Anticipated trial start date

2018 Year 10 Month 17 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

I have finished observing 20 cases.


Management information

Registered date

2019 Year 05 Month 13 Day

Last modified on

2019 Year 05 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041841


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name