UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052873 |
|---|---|
| Receipt number | R000058424 |
| Scientific Title | The Hiroshima study on atherosclerosis and cardiovascular disease in atomic bomb survivors |
| Date of disclosure of the study information | 2024/12/15 |
| Last modified on | 2025/11/25 12:08:26 |
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Basic information
Public title
The Hiroshima study on atherosclerosis and cardiovascular disease in atomic bomb survivors
Acronym
Hiroshima ACA study
Scientific Title
The Hiroshima study on atherosclerosis and cardiovascular disease in atomic bomb survivors
Scientific Title:Acronym
Hiroshima ACA study
Region
| Japan |
Condition
Condition
Cardiovascular disease, Type 2 diabetes mellitus, Hypertension, Hyperlipidemia, Renal dysfunction
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Nephrology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study is to investigate the relationship between radiation exposure and atherosclerosis and cardiovascular diseases in the Hiroshima atomic bomb survivors.
Basic objectives2
Others
Basic objectives -Others
1.To Investigate the relationship between radiation exposure and atherosclerosis using indices from carotid artery ultrasonography.
2.To investigate the relationship between radiation exposure and arterial stiffness using the Cardio Ankle Vascular Index.
3.To investigate the relationship between radiation exposure and risk factors for cardiovascular disease, such as hypertension, diabetes, and kidney damage, as well as cardiovascular death.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Progression of atherosclerosis
Key secondary outcomes
1. Incidence of cardiovascular disease
2. Incidence of hypertension
3. Incidence of diabetes
4. Incidence of renal dysfunction
5. Other cardiovascular risk factors
6. Cardiovascular death
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants were recruited after undergoing general health examinations at the Health Management and Promotion Center of the Hiroshima Atomic Bomb Casualty Council.
Key exclusion criteria
Health checkup participants who did not consent to the use of test results for research.
Target sample size
7120
Research contact person
Name of lead principal investigator
| 1st name | Nobuo |
| Middle name | |
| Last name | Sasaki |
Organization
Hiroshima Atomic Bomb Casualty Council
Division name
Health Management and Promotion Center
Zip code
730-0052
Address
3-8-6, Senda-machi, Naka-ku, Hiroshima
TEL
082-243-2451
n-sasaki@gentaikyo.or.jp
Public contact
Name of contact person
| 1st name | Tomomi |
| Middle name | |
| Last name | Fujita |
Organization
Hiroshima Atomic Bomb Casualty Council
Division name
Health Management and Promotion Center
Zip code
730-0052
Address
3-8-6, Senda-machi, Naka-ku, Hiroshima
TEL
082-243-2451
Homepage URL
t-ikyoku@gentaikyo.or.jp
Sponsor or person
Institute
Hiroshima Atomic Bomb Casualty Council
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima Atomic Bomb Casualty Council committee
Address
3-8-6, Senda-machi, Naka-ku, Hiroshima
Tel
0822432451
y-ueno@gentaikyo.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
| 2024 | Year | 12 | Month | 15 | 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
7120
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
| 2023 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The participants in this study were atomic bomb survivors who underwent general medical examinations at the Health Management and Promotion Center of Hiroshima Atomic Bomb Casualty Council between January 1982 and December 2017.Radiation dose data were provided by the ABS study.
Management information
Registered date
| 2023 | Year | 11 | Month | 22 | Day |
Last modified on
| 2025 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058424
