UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020897 |
|---|---|
| Receipt number | R000022951 |
| Scientific Title | Biosignal monitoring in cardiovascular patients for development of new driver safety system |
| Date of disclosure of the study information | 2016/02/05 |
| Last modified on | 2017/02/07 14:12:22 |
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Basic information
Public title
Biosignal monitoring in cardiovascular patients for development of new driver safety system
Acronym
Biosignal monitoring for cardiovascular stress during driving.
Scientific Title
Biosignal monitoring in cardiovascular patients for development of new driver safety system
Scientific Title:Acronym
Biosignal monitoring for cardiovascular stress during driving.
Region
| Japan |
Condition
Condition
arrhythmia
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Biosignal monitoring in cardiovascular patients for development of new driver safety system
Basic objectives2
Others
Basic objectives -Others
Biosignal monitoring
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in electrocardiography during driving
Key secondary outcomes
Driving-induced changes in pulse wave, blood pressure, body temperature, behavior patterns (walking pattern, pedaometer, sleep period, blood glucose fluctuation)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
exercise challenge by Treadmill test or cardiopulmonary exercise test.
Interventions/Control_2
driving challenge by simulator
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cardiovascular patients who have been diagnosed arrhythmia and healthy counterparts who have driver license with informed consent.
Key exclusion criteria
Unstable angina, lethal arrhythmia, patients who is contraindicated for exercise challenge.
limiting condition for exercise.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toyoaki Murohara |
Organization
Nagoya University
Division name
Department of Cardiology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
052-744-2147
murohara@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuko K Bando |
Organization
Nagoya University
Division name
Department of Cardiology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
052-744-2147
Homepage URL
ybando@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Toyota Motor Corporation
Name of secondary funder(s)
Denso Corporation
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
名古屋大学医学部附属病院、名古屋大学National Innovation Complex（健常者のみ）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 05 | 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
| 2015 | Year | 02 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 05 | Day |
Last modified on
| 2017 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022951
