UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030178 |
|---|---|
| Receipt number | R000034177 |
| Scientific Title | Development of non-invasive estimation method of cardiac output utilizing the lung-finger circulating time measurement. |
| Date of disclosure of the study information | 2017/12/01 |
| Last modified on | 2018/06/01 10:54:37 |
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Basic information
Public title
Development of non-invasive estimation method of cardiac output utilizing the lung-finger circulating time measurement.
Acronym
Development of non-invasive estimation method of cardiac output utilizing the lung-finger circulating time measurement.
Scientific Title
Development of non-invasive estimation method of cardiac output utilizing the lung-finger circulating time measurement.
Scientific Title:Acronym
Development of non-invasive estimation method of cardiac output utilizing the lung-finger circulating time measurement.
Region
| Japan |
Condition
Condition
heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. The lung-to-finger circulation time (LFCT) is defined as the time from start of rebreathing after deoxygenation by a temporary breath-holding to the nadir of the oxygen saturation. To compare LFCT and cardiac index (CI) obtained from another method.
2. The accuracy of cardiac index (CI) measurement using LFCT method by a oxygen saturation sensor which we have developed together with Fuji Xerox Co., Ltd. will be confirmed by the simultaneous measurements utilizing the 2 methods.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship will be analyzed between CI obtained by cardiac magnetic resonance (CMR) or cardiac catheterization and LFCT that is measured during the patients awake or measured from the data of overnight polysomnography. The accuracy of the oxygen saturation (SpO2) obtained from our co-developed system will be confirmed by comparison with those obtained from the oxygen values from the conventional measurement of arterial oxygen partial pressure during the catheterization procedure or SpO2 from a commercially available SPO2 monitor device.
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 |
Interventions/Control_1
Fx sensor
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The study subjects will be recruited from the patients who will be admitted to the cardiovascular department in Saiseikai Futsukaichi hospital to undergo the cardiac catheterization or CMR measurement.
Key exclusion criteria
The patients who have shunt for hemodialysis or who cannot perform or are not suitable for breath-holding like patients with dementia or acute myocardial infarction will be excluded.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiaki Kadokami |
Organization
Fukuokaken Saiseikai Futsukaichi Hospital
Division name
Cardiovascular Medicine
Zip code
Address
3-13-1, Yu-machi, Chikushino-shi, Fukuoka
TEL
092-923-1551
t-kadokami@saiseikai-futsukaichi.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsumi Hayashi |
Organization
Fukuokaken Saiseikai Futsukaichi Hospital
Division name
Clinical research and education center
Zip code
Address
3-13-1, Yu-machi, Chikushino-shi, Fukuoka
TEL
092-923-1551
Homepage URL
s-futsu6@saiseikai-futsukaichi.org
Sponsor or person
Institute
Fukuokaken Saiseikai Futsukaichi Hospital
Cardiovascular Medicine
Institute
Department
Personal name
Funding Source
Organization
Fuji Xerox Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 12 | Month | 01 | 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
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 16 | Day |
Last follow-up date
| 2018 | Year | 02 | Month | 05 | Day |
Date of closure to data entry
| 2018 | Year | 02 | Month | 08 | Day |
Date trial data considered complete
| 2018 | Year | 02 | Month | 13 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 30 | Day |
Last modified on
| 2018 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034177
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
