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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031719
Receipt No. R000036185
Scientific Title Development of scoring system to predict atrial fibrillation in medical and occupational health checkup and establishment of prognostic risk stratification in patients with atrial fibrillation
Date of disclosure of the study information 2018/03/14
Last modified on 2018/09/13

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Basic information
Public title Development of scoring system to predict atrial fibrillation in medical and occupational health checkup and establishment of prognostic risk stratification in patients with atrial fibrillation
Acronym Development of scoring system to predict atrial fibrillation in medical and occupational health checkup and establishment of prognostic risk stratification in patients with atrial fibrillation
Scientific Title Development of scoring system to predict atrial fibrillation in medical and occupational health checkup and establishment of prognostic risk stratification in patients with atrial fibrillation
Scientific Title:Acronym Development of scoring system to predict atrial fibrillation in medical and occupational health checkup and establishment of prognostic risk stratification in patients with atrial fibrillation
Region
Japan

Condition
Condition Atrial fibrillation (AF)
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To build risk prediction models for AF development
Basic objectives2 Others
Basic objectives -Others With retrospective analysis of the datasets of the Chronic Heart Failure Analysis and Registry in the Tohoku District (CHART)-2 Study and the occupational health checkup cohort of Sendai Sangyo-Igaku Kyougikai, we will build risk prediction models for AF development.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Atrial fibrillation
Key secondary outcomes

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
45 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Age>=45 years
Key exclusion criteria No exclusion criteria
Target sample size 114000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Shimokawa
Organization Tohoku University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address Seiryo-machi 1-1, Aobaku Sendai
TEL +81227177153
Email nochioka@cardio.med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kotaro Nochioka
Organization Tohoku University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address Seiryo-machi 1-1, Aobaku Sendai
TEL +81227177153
Homepage URL http://www.med.tohoku.ac.jp/public/doc/2017-1-555.pdf
Email nochioka@cardio.med.tohoku.ac.jp

Sponsor
Institute Japan Agency for Medical Research and Development
Institute
Department

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

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
2018 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 No longer recruiting
Date of protocol fixation
2017 Year 09 Month 28 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We will evaluate occurrence or recurrence of AF in general population from Japanese cohorts.

Management information
Registered date
2018 Year 03 Month 14 Day
Last modified on
2018 Year 09 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036185

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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