UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045120 |
|---|---|
| Receipt number | R000051544 |
| Scientific Title | A study of vascular function in A-bomb survivor. |
| Date of disclosure of the study information | 2021/08/11 |
| Last modified on | 2026/02/13 11:41:21 |
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Basic information
Public title
A study of vascular function in A-bomb survivor.
Acronym
A study of vascular function in A-bomb survivor.
Scientific Title
A study of vascular function in A-bomb survivor.
Scientific Title:Acronym
A study of vascular function in A-bomb survivor.
Region
| Japan |
Condition
Condition
atherosclerosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate vascular function in A-bomb survivor.
Basic objectives2
Others
Basic objectives -Others
The objective of this study is to evaluate vascular function in A-bomb survivor.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
FMD, NID, PWV, IMT, arterial diameter, ROCK activity
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent vascular function examinations at Hiroshima University Hospital
Key exclusion criteria
Are considered not eligible for the study by the attending doctor due to other reasons
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | yukihito |
| Middle name | |
| Last name | Higashi |
Organization
Hiroshima University Hospital
Division name
Medical Center for Translational and Clinical Research
Zip code
734-8551
Address
1-2-3 Kasumi, Minamiku, Hiroshima
TEL
082-257-5831
yhigashi@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | yukihito |
| Middle name | |
| Last name | higashi |
Organization
Hiroshima University Hospital
Division name
Medical Center for Translational and Clinical Research
Zip code
734-8551
Address
1-2-3 Kasumi, Minamiku, Hiroshima
TEL
082-257-5831
Homepage URL
yhigashi@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Self-procurement
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
Ethical Committee for Epidemiology of Hiroshima University
Address
1-2-3 Kasumi, Minamiku, Hiroshima
Tel
082-257-5831
hiroshima-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
| 2021 | Year | 08 | Month | 11 | Day |
Related information
URL releasing protocol
https://doi.org/10.3389/fcvm.2023.1122794
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.3389/fcvm.2023.1122794
Number of participants that the trial has enrolled
131
Results
There was no significant difference in FMD, NID, baPWV, or brachial artery IMT between control subjects and atomic bomb survivors. After adjustment of confounding factors, there was still no significant difference in FMD, NID, baPWV, or brachial artery IMT between control subjects and atomic bomb survivors. Radiation dose from the atomic bomb was negatively correlated with FMD (= -0.73, P = 0.02), whereas radiation dose was not correlated with NID, baPWV or brachial artery IMT.
Results date posted
| 2026 | Year | 02 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The baseline clinical characteristics of the 1,153 control subjects and 131 atomic bomb survivors are summarized in Table 1.
Participant flow
FMD, NID, baPWV, and brachial artery IMT were measured and compared with the control group.We used the dose of exposure to radiation from neutrons and gamma rays estimated by using the Atomic Bomb Survivor 1993 Dose (ABS93D).
Adverse events
There were no adverse events.
Outcome measures
FMD, NID, baPWV, and brachial artery IMT
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
vascular function and risk factors
Management information
Registered date
| 2021 | Year | 08 | Month | 11 | Day |
Last modified on
| 2026 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051544
