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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024418
Receipt No. R000028104
Scientific Title Japanese eLderly data Of Normal echocardioGraphy (J-LONG) study
Date of disclosure of the study information 2016/10/15
Last modified on 2016/10/15

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Basic information
Public title Japanese eLderly data Of Normal echocardioGraphy (J-LONG) study
Acronym J-LONG study
Scientific Title Japanese eLderly data Of Normal echocardioGraphy (J-LONG) study
Scientific Title:Acronym J-LONG study
Region
Japan

Condition
Condition cardiovascular diseases
Classification by specialty
Medicine in general Cardiology Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To establish a reference value of echocardiography in the normal aging process of the late elderly
Basic objectives2 Others
Basic objectives -Others To clarify the differences of the echocardiographic parameters between healthy subjects and patients with cardiovascular diseases in the late elderly
Trial characteristics_1 Others
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes To establish a reference value of echocardiography in
the healthy late elderly
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
75 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Healthy group
2. Flail group.
3. Lifestyle-related disease and CKD (lifestyle-related disease group).
4. Aortic valve stenosis (AS) group.
5. Left ventricular ejection fraction preserved heart failure (HFpEF) group.
Key exclusion criteria Subjects who do not meet the selection criteria
Target sample size 1600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiro Seo
Organization University of Tsukuba
Division name Fuculty of Medicine, Cardiovascular Division
Zip code
Address 1-1-1 Tennodai, Tsukuba, Japan
TEL 0298533142
Email yo-seo@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihiro Seo
Organization University of Tsukuba
Division name Fuculty of Medicine, Cardiovascular Division
Zip code
Address 1-1-1 Tennodai, Tsukuba, Japan
TEL 0298533142
Homepage URL
Email yo-seo@md.tsukuba.ac.jp

Sponsor
Institute Japanese Society of Echocardiography
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 10 Month 15 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 Enrolling by invitation
Date of protocol fixation
2016 Year 09 Month 23 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective study
Random sampling

Management information
Registered date
2016 Year 10 Month 15 Day
Last modified on
2016 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028104

Research Plan
Registered date File name
2016/10/15 研究実施計画.docx

Research case data specifications
Registered date File name
2016/10/15 手書き症例No.docx

Research case data
Registered date File name
2016/10/15 J-LONG.xlsx


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