UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036192 |
|---|---|
| Receipt number | 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 21:55:07 |
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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
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
kt15613@kchnet.or.jp
Sponsor or person
Institute
Department of Anesthesiology, Kurashiki Central Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041229
