UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047406 |
|---|---|
| Receipt number | R000054063 |
| Scientific Title | Study of Strictly Organization Beside AF in Niigata |
| Date of disclosure of the study information | 2022/04/06 |
| Last modified on | 2023/04/06 09:10:47 |
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Basic information
Public title
Study of Strictly Organization Beside AF in Niigata
Acronym
SOBANI-AF study
Scientific Title
Study of Strictly Organization Beside AF in Niigata
Scientific Title:Acronym
SOBANI-AF study
Region
| Japan |
Condition
Condition
Atrial fibrillation
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to reduce the non-examination rate by introducing a new method of recommending examinations for those who have undergone occupational medical examinations who have been diagnosed with atrial fibrillation. Achieving this will lead to the establishment of a system to improve the treatment of patients with atrial fibrillation in the prefecture by inducing appropriate treatment for untreated patients. We would like to build an organic relationship between medical examination institutions, on-the-job doctors, and hospitals, and develop it as one of the central projects for cardiovascular disease control in Niigata Prefecture.
Basic objectives2
Others
Basic objectives -Others
In December 2018, the "Basic Law Concerning Measures for Stroke, Heart Disease and Other Cardiovascular Diseases to Extend Healthy Life Expectancy" (hereinafter referred to as "Basic Law for Cardiovascular Disease Countermeasures") was enacted. Based on this law, the Basic Plan for Promotion of Cardiovascular Disease Countermeasures was approved by the Cabinet in October 2020, and each prefecture will formulate a prefectural plan for stroke and cardiovascular disease according to the local circumstances. .. The Niigata Prefectural Cardiovascular Disease Countermeasures Promotion Council was established in 2021, and it was confirmed that the cooperation of medical examinations including medical examination institutions for the treatment of atrial fibrillation in Niigata Prefecture would be reconstructed to improve the health of the citizens of the prefecture. Was done.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of examinees who had an electrocardiogram of atrial fibrillation in the medical examination and checked "under treatment" in the item of Q5 "heart disease" of the specific medical examination questionnaire of the next year, the next year when atrial fibrillation was pointed out. The treatment rate is calculated by dividing by the number of people who have undergone a medical examination.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Those who have not been treated for atrial fibrillation (those who have no check in the following past / current medical history and those who have a check in the history and who have been diagnosed with atrial fibrillation on the electrocardiogram) are targeted.
If the letter of introduction is not sent to the Niigata Prefectural Occupational Health Medical Association 3 months after the letter is sent, contact the company's health manager and ask for a medical examination again.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
A person diagnosed with atrial fibrillation by electrocardiogram
In addition, those who have no check or have a check in the history of atrial fibrillation in the history of atrial fibrillation check column.
Key exclusion criteria
In "Handling of personal information" at the time of occupational medical examination, some disagreement items, (6) Research aimed at improving medical education and public health (in this case, individuals can be identified. Those who have undergone a medical examination with a check mark.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Inomata |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Department of Cardiovascular Medicine
Zip code
951-8510
Address
757 ichiban-cho, asahimachi-dori, chuo-ku, niigata
TEL
025-227-2185
inotaka@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Kiminori |
| Middle name | |
| Last name | Kato |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Department of Prevention of Noncommunicable Diseases and Promotion of Health Checkup
Zip code
951-8510
Address
757 ichiban-cho, asahimachi-dori, chuo-ku, niigata
TEL
025-227-2185
Homepage URL
kkato48@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
Niigata University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Niigata University
Address
757 ichiban-cho, asahimachi-dori, chuo-ku, niigata
Tel
025-227-2625
ethics@adm.niigata-u.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
| 2022 | Year | 04 | Month | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 06 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 04 | Month | 05 | Day |
Last modified on
| 2023 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054063
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