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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000019903
Receipt No. R000022981
Scientific Title A study of the arrhythmia surveillance using Apple's ResearchKit (Beats & Stroke)
Date of disclosure of the study information 2015/11/25
Last modified on 2017/01/19

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Basic information
Public title A study of the arrhythmia surveillance using Apple's ResearchKit (Beats & Stroke)
Acronym Beats & Stroke
Scientific Title A study of the arrhythmia surveillance using Apple's ResearchKit (Beats & Stroke)
Scientific Title:Acronym Beats & Stroke
Region
Japan

Condition
Condition arrhythmia, stroke
Classification by specialty
Cardiology Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This clinical study utilizes iPhones for the early detection of arrhythmias and strokes to maintain the quality of life.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The assessment of the quality of the data collected by iPhones.
Key secondary outcomes Health care data analysis of arrhythmias
Risk analysis of arrhythmias and strokes
The usefulness of using iPhone sensors for stroke detection

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Gender Male and Female
Key inclusion criteria iPhone users in Japan / US
Persons who are able to handle the application with or without any assistance
Persons in whom it is possible to obtain informed consent for the application
Key exclusion criteria Persons who refuse to give informed consent for the application
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seiji Takatsuki
Organization Keio University School of Medicine
Division name Department of Cardiology
Zip code
Address 35 Shinanomachi Shinjuku-ku, Tokyo
TEL +81333531211
Email seiji.takatsuki@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Takehiro Kimura
Organization Keio University School of Medicine
Division name Department of Cardiology
Zip code
Address 35 Shinanomachi Shinjuku-ku, Tokyo
TEL +81333531211
Homepage URL http://www.keioep.com/heartbrain/
Email keio.heartandbrain@gmail.com

Sponsor
Institute Keio University School of Medicine
Department of Cardiology
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2015 Year 11 Month 25 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 Terminated
Date of protocol fixation
2015 Year 11 Month 20 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design: Cross sectional study

Recruiting Method: Patients visiting our facility

Examination items:
Health: steps, walking + running distance, flights climbed, active energy, number of times fallen, heart rate
Questionnaire: 21 questions regarding the previous history and quality of life
Motor paralysis evaluation: gyro data
Face exercise evaluation: camera data
Coordinated exercise evaluation: gyro data

Management information
Registered date
2015 Year 11 Month 23 Day
Last modified on
2017 Year 01 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022981

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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