UMIN-CTR Clinical Trial

Basic information
Public title	Left sided ventricular-arterial coupling assessment using non-invasive circulatory monitoring devices
Acronym	Left sided ventricular-arterial coupling assessment using non-invasive circulatory monitoring devices
Scientific Title	Left sided ventricular-arterial coupling assessment using non-invasive circulatory monitoring devices
Scientific Title:Acronym	Left sided ventricular-arterial coupling assessment using non-invasive 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	Efficacy
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	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	We evaluate the left ventricular arterial coupling under resting state, body position change and exercise using echocardiography.
Interventions/Control_2	We evaluate the left ventricular arterial coupling under resting state, body position change and exercise using non invasive circulatory monitoring devices.
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
Last 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
1st 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	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	Enrolling by invitation
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 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041103