UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036041
Receipt number R000041052
Scientific Title Cross-sectional and retrospective cohort study to investigate serum N-terminal pro-brain natriuretic peptide level in elderly people
Date of disclosure of the study information 2019/03/08
Last modified on 2023/06/05 19:19:13

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Basic information

Public title

Cross-sectional and retrospective cohort study to investigate serum N-terminal pro-brain natriuretic peptide level in elderly people

Acronym

Serum N-terminal pro-brain natriuretic peptide level in elderly people

Scientific Title

Cross-sectional and retrospective cohort study to investigate serum N-terminal pro-brain natriuretic peptide level in elderly people

Scientific Title:Acronym

Serum N-terminal pro-brain natriuretic peptide level in elderly people

Region

Japan


Condition

Condition

Cardiovascular disease
Hypertension

Classification by specialty

Medicine in general Cardiology Geriatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of the present study is to investigate the association between cardiovascular risk factors and serum N-terminal pro-brain natriuretic peptide level in middle-aged and elderly people.

Basic objectives2

Others

Basic objectives -Others

To evaluate the association between serum N-terminal pro-brain natriuretic peptide level and hypertension, diabetes, dyslipidemia, hyperuricemia, renal dysfunction, atrial fibrillation, ischemic heart disease, stroke, and other cardiovascular comorbidities.

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Serum N-terminal pro-brain natriuretic peptide level in elderly people

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

70 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.Participants were recruited after undergoing general health examinations at the Health Management and Promotion Center of the Hiroshima Atomic Bomb Casualty Council.
2.They agreed to assess serum N-terminal pro-brain natriuretic peptide level.

Key exclusion criteria

1.Age of <70 years.
2.Participants had any symptoms for heart failure.

Target sample size

9300


Research contact person

Name of lead principal investigator

1st name Sasaki
Middle name
Last name Nobuo

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


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

公益財団法人広島原爆障害対策協議会(広島県)
Hiroshima Atomic Bomb Casualty Council, Hiroshima, Japan


Other administrative information

Date of disclosure of the study information

2019 Year 03 Month 08 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


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

Completed

Date of protocol fixation

2014 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2015 Year 01 Month 05 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

An observational study
Cross-sectional and retrospective cohort analysis


Management information

Registered date

2019 Year 02 Month 28 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=R000041052


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name