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 2023/06/05 19:13:47

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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

Email

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


Email

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

Email

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 2021 was collected.
We are collecting follow-up data for 2022.


Management information

Registered date

2018 Year 12 Month 25 Day

Last modified on

2023 Year 06 Month 05 Day



Link to view the page

Value
https://center6.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