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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036192
Receipt No. R000041229
Scientific Title Left ventricular arterial coupling assessment using noninvasive circulatory monitoring devices.
Date of disclosure of the study information 2019/03/14
Last modified on 2019/03/13

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Basic information
Public title Left ventricular arterial coupling assessment using noninvasive circulatory monitoring devices.
Acronym Left ventricular arterial coupling assessment using noninvasive circulatory monitoring devices.
Scientific Title Left ventricular arterial coupling assessment using noninvasive circulatory monitoring devices.
Scientific Title:Acronym Left ventricular arterial coupling assessment using noninvasive circulatory monitoring devices.
Region
Japan

Condition
Condition healthy volunteer
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare and examine the measures of interaction between the left ventricle and arterial system using non invasive circulatory monitoring devices and that using echocardiography.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The validity of the estimated parameters including stroke volume, left ventricular end diastolic volume and Ees to Ea ratio calculated using non invasive circulatory monitoring devices and echocardiography.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Using Non invasive circulatory monitoring devices /Using echocardiography
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
50 years-old >=
Gender Male and Female
Key inclusion criteria Healthy medical doctor, nurse and clinical engineer who belong to the institution.
Key exclusion criteria Subjects with valvular disease, ischemic heart disease, hypertension and/or arrhythmia, atherosclerotic disease, endocrine disease including thyroid dysfunction and/or diabetes mellitus
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Kosaku
Middle name
Last name Toyota
Organization Kurashiki Central Hospital
Division name Department of Anesthesiology
Zip code 710-8602
Address 1-1-1 Miwa, Kurashiki, Okayama
TEL 086-422-0210
Email kt15613@kchnet.or.jp

Public contact
Name of contact person
1st name Kosaku
Middle name
Last name Toyota
Organization Kurashiki Central Hospital
Division name Department of Anesthesiology
Zip code 710-8602
Address 1-1-1 Miwa, Kurashiki, Okayama
TEL 086-422-0210
Homepage URL
Email kt15613@kchnet.or.jp

Sponsor
Institute Department of Anesthesiology, Kurashiki Central Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Kurashiki Central Hospital Ethics Committee
Address 1-1-1 Miwa, Kurashiki, Okayama
Tel 086-422-0210
Email kenkyu@kchnet.or.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
2019 Year 03 Month 14 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 Preinitiation
Date of protocol fixation
2019 Year 02 Month 27 Day
Date of IRB
2019 Year 02 Month 27 Day
Anticipated trial start date
2019 Year 03 Month 14 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 03 Month 13 Day
Last modified on
2019 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041229

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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