UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018747 |
|---|---|
| Receipt number | R000021689 |
| Scientific Title | Japan Atherosclerosis Society Cohort Study |
| Date of disclosure of the study information | 2015/09/01 |
| Last modified on | 2023/04/11 17:45:37 |
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Basic information
Public title
Japan Atherosclerosis Society Cohort Study
Acronym
JAS COHORT STUDY
Scientific Title
Japan Atherosclerosis Society Cohort Study
Scientific Title:Acronym
JAS COHORT STUDY
Region
| Japan |
Condition
Condition
Dyslipidemia
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Nephrology | Neurology | Geriatrics |
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Survey of dyslipidemia treatment agents and the achievement of the lipid management target level, and the evaluation of the relationship between cardiovascular events, dyslipidemia treatment agents, and the achievement of the lipid management target level of management category in the Japan Atherosclerosis Society (JAS) Guidelines for the Diagnosis and Prevention of Atherosclerotic Cardiovascular Diseases in Japan-2012 Version
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1.Survey of Dyslipidemia treatment agents and the achievement of the Lipid Management Target Level of management category in the JAS Guidelines for the Diagnosis and Prevention of Atherosclerotic Cardiovascular Diseases in Japan-2012 Version
2.Relationships among cardiovascular events, dyslipidemia treatment agents, and the achievement of the Lipid Management Target Level of management category in the JAS Guidelines for the Diagnosis and Prevention of Atherosclerotic Cardiovascular Diseases in Japan-2012 Version
Key secondary outcomes
Non-fatal myocardial infarction and unstable angina
Non-fatal stroke
Coronary intervention
Atrial fibrillation
Death of cardiovascular cause
Death of non-cardiovascular cause
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
| 40 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants diagnosed as dyslipidemia by the JAS Guidelines for the Diagnosis and Prevention of Atherosclerotic Cardiovascular Diseases in Japan-2012 Version and followed and treated at out-patient clinic including diet therapy
1.Aged 40-74 years
2.Either gender
3.No history of cardiovascular disease
Key exclusion criteria
1.Participants with familiar hypercholesterolemia, familial type III hyperlipidemia, and primary hyperchylomicronemia
2.Past history of stroke
3.Participants who are pregnant or lactating or intend to become pregnant
4.Participants with liver cirrhosis
5.Participants who were diagnosed as hyperthyroidism or hypothyroidism or stable at least 3 months by the treatment before entry
6.Participants who have experienced major surgery within the last 30 days
7.Participants who are currently receiving with oral retinoid agent for acne or psoriasis, systemic corticosteroids, or cyclosporine
8.Participants treated with anti-obesity drugs within the last 3 months
9.Participants who participated in the clinical trial or have been administed any investigational drug within the past 3 months, or the medical equipment
10.Participants who have received or a plan for a bariatric surgery for weight loss (gastric bypass, etc.)
11.Participants who are found to be HIV seropositive
12.Participants who have cancer, except for receiving the appropriate treatment for the localized basal cell skin cancer or mucosa in cervical cancer, or a history of cancer within the past 5 years
13.Participants with geographic elements or social element to limit the participation during the study period (including a transfer), or it is to be expected
14.Participants who are inadequate to enroll the study determined by the research doctor
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Seiji |
| Middle name | |
| Last name | Umemoto |
Organization
Japan Atherosclerosis Society
Division name
JAS Cohort Study group
Zip code
113-0033
Address
28-8, Hongo 3-chome, Bunkyo-ku, Tokyo
TEL
03-5802-7711
jascohort@j-athero.or.jp
Public contact
Name of contact person
| 1st name | Seiji |
| Middle name | |
| Last name | Umemoto |
Organization
Japan Atherosclerosis Society
Division name
JAS Cohort Study group
Zip code
113-0033
Address
28-8, Hongo 3-chome, Bunkyo-ku, Tokyo
TEL
03-5802-7711
Homepage URL
http://www.j-athero.org/other/jas_cohort_study.html
jascohort@j-athero.or.jp
Sponsor or person
Institute
JAS Cohort Study group
Institute
Department
Personal name
Funding Source
Organization
Japan Atherosclerosis Society
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
Japan Atherosclerosis Society Ethics Committee
Address
c/o Nichinai-Kaikan B1 3-28-8 Hongo, Bunkyo-ku,Tokyo 113-0033, Japan
Tel
03-5802-7711
jas@j-athero.or.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
| 2015 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.j-athero.org/
Publication of results
Unpublished
Result
URL related to results and publications
http://www.j-athero.org/
Number of participants that the trial has enrolled
1582
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
| 2015 | Year | 07 | Month | 06 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 06 | Month | 30 | Day |
Other
Other related information
In this cohort study, we will recruit the participants diagnosed with dyslipidemia during the visit to the period of one year from July 6, 2015 at the research participant out-patient institutions, who meet all of the inclusion criteria, and do not fall in any of the exclusion criteria, and observe the development of atherosclerotic disease after the acquisition of the baseline characteristics (age, sex, body weight, hight, sitting blood pressure, weist circumference, lipid profile, glucose, HbA1c, liver function, creatinine, uric acid, ankle brachial index, concomitant drugs, anti-lipidemic drugs and nutritional guidance) of the participants every six months for at least five years.
Management information
Registered date
| 2015 | Year | 08 | Month | 21 | Day |
Last modified on
| 2023 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021689
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
