UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Biosignal monitoring in cardiovascular patients for development of new driver safety system
Title of the study (Brief title)	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	Toyoaki Murohara
Organization	Nagoya University
Division name	Department of Cardiology
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL	052-744-2147
Email	murohara@med.nagoya-u.ac.jp

Public contact
Name of contact person	Yasuko K Bando
Organization	Nagoya University
Division name	Department of Cardiology
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL	052-744-2147
Homepage URL
Email	ybando@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University
Institute
Department

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

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2015 Year 02 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022951