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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036722
Receipt No. 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

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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
Institute Kanazawa University
Institute
Department

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
URL(English) https://upload.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


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