UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031719 |
|---|---|
| Receipt number | 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 | 2021/04/19 12:35:00 |
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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 | Hiroaki |
| Middle name | |
| Last name | Shimokawa |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
9808574
Address
Seiryo-machi 1-1, Aobaku Sendai
TEL
+81227177153
nochioka@cardio.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Kotaro |
| Middle name | |
| Last name | Nochioka |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
9808574
Address
Seiryo-machi 1-1, Aobaku Sendai
TEL
+81227177153
Homepage URL
http://www.med.tohoku.ac.jp/public/doc/2017-1-555.pdf
nochioka@cardio.med.tohoku.ac.jp
Sponsor or person
Institute
Japan Agency for Medical Research and Development
Institute
Department
Personal name
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
Ethics Committee, Tohoku University Graduate School of Medicine
Address
Seiryo-machi 1-1, Aobaku, Sendai
Tel
0227178007
med-kenkyo@grp.tohoku.ac.jp
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
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S2352906721000506?via%3Dihub
Number of participants that the trial has enrolled
99662
Results
Age, sex, waist circumference, blood pressure, LDL cholesterol, and ganma-GTP were associated with new-onset of AF. Using the Minnesota code information, the AUC significantly improved from 0.82 to 0.84 in the derivation cohort and numerically improved from 0.78 to 0.79 in the validation cohort, and from 0.77 to 0.79 in the Hisayama cohort.
Results date posted
| 2021 | Year | 04 | Month | 19 | Day |
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 | 09 | Month | 28 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 28 | Day |
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
| 2021 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036185
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
