UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035361 |
|---|---|
| Receipt number | R000040295 |
| Scientific Title | A prospective cohort study to clarify the risk factors for all-cause and cardiovascular death in elderly people |
| Date of disclosure of the study information | 2019/01/04 |
| Last modified on | 2025/01/07 12:31:59 |
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Basic information
Public title
A prospective cohort study to clarify the risk factors for all-cause and cardiovascular death in elderly people
Acronym
Risk factors for all-cause and cardiovascular death in elderly
Scientific Title
A prospective cohort study to clarify the risk factors for all-cause and cardiovascular death in elderly people
Scientific Title:Acronym
Risk factors for all-cause and cardiovascular death in elderly
Region
| Japan |
Condition
Condition
Hypertension
Dyslipidemia
Type 2 diabetes mellitus,
Hyperuricemia
Cardiovascular disease
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Nephrology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study is to identify the determinants of future cardiovascular diseases and death among various clinical measures of hemodynamics (such as blood pressure), lipid, carbohydrate, and protein metabolisms, and lifestyle (diurnal rhythms and sleep), and to understand the interrelation among these factors in elderly people.
Basic objectives2
Others
Basic objectives -Others
1. To investigate the impacts of hypertension, increased pulse pressure, and blood pressure variability on cardiovascular and all-cause mortality in elderly people.
2. To investigate the association of serum levels of low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglyceride with cardiovascular and all-cause mortality in elderly people.
3. To investigate the impacts of impaired glucose metabolism on cardiovascular and all-cause mortality in elderly people.
4. To investigate the impact of hyperuricemia on cardiovascular and all-cause mortality in elderly people.
5. To investigate the association of serum N-terminal pro-brain natriuretic peptide level with cardiovascular and all-cause mortality in elderly people.
6. To investigate the impact of sleep habits including sleep duration, bedtime, wake time, and sleep quality on cardiovascular and all-cause mortality in elderly people.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.All-cause and cardiovascular death
Key secondary outcomes
1. Renal dysfunction
2. Proteinuria
3. Atrial fibrillation
4. White matter lesions
5. Common carotid artery measurements
6. Cardio-ankle vascular index
7. Ankle-brachial index
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
| 71 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Participants who were recruited after undergoing general health examinations at the Health Management and Promotion Center of the Hiroshima Atomic Bomb Casualty Council.
2. Participants who provided written informed consent for the study.
Key exclusion criteria
1. Age of <71 years.
Target sample size
10000
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
None
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
082-243-2451
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
| 2019 | Year | 01 | Month | 04 | 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
8735
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
| 2018 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2034 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A prospective observational study
Follow-up data for 2023 was collected.
We are collecting follow-up data for 2024.
Management information
Registered date
| 2018 | Year | 12 | Month | 25 | Day |
Last modified on
| 2025 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040295
