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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035361
Receipt No. R000040295
Official scientific title of the study 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 2019/01/10

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Basic information
Official scientific title of the study A prospective cohort study to clarify the risk factors for all-cause and cardiovascular death in elderly people
Title of the study (Brief title) 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 Nobuo Sasaki
Organization Hiroshima Atomic Bomb Casualty Council
Division name Health Management and Promotion Center
Address 3-8-6, Senda-machi, Naka-ku, Hiroshima
TEL 082-243-2451
Email n-sasaki@gentaikyo.or.jp

Public contact
Name of contact person Naomi Yuzono
Organization Hiroshima Atomic Bomb Casualty Council
Division name Health Management and Promotion Center
Address 3-8-6, Senda-machi, Naka-ku, Hiroshima
TEL 082-243-2451
Homepage URL
Email n-yuzono@gentaikyo.or.jp

Sponsor
Institute Hiroshima Atomic Bomb Casualty Council
Institute
Department

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)

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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 11 Month 01 Day
Anticipated trial start date
2019 Year 01 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information A prospective observational study

Management information
Registered date
2018 Year 12 Month 25 Day
Last modified on
2019 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040295

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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