UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024418 |
|---|---|
| Receipt number | 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 | 2020/10/18 10:03:18 |
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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 | Yoshihiro |
| Middle name | |
| Last name | Seo |
Organization
University of Tsukuba
Division name
Fuculty of Medicine, Cardiovascular Division
Zip code
3058575
Address
1-1-1 Tennodai, Tsukuba, Japan
TEL
0298533142
yo-seo@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Seo |
Organization
University of Tsukuba
Division name
Fuculty of Medicine, Cardiovascular Division
Zip code
3058575
Address
1-1-1 Tennodai, Tsukuba, Japan
TEL
0298533142
Homepage URL
yo-seo@md.tsukuba.ac.jp
Sponsor or person
Institute
Japanese Society of Echocardiography
Institute
Department
Personal name
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
University of Tsukuba
Address
1-1-1 Tennodai, Tsukuba, Japan
Tel
0298533142
yo-seo@md.tsukuba.ac.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
| 2016 | Year | 10 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s12574-020-00469-7
Number of participants that the trial has enrolled
402
Results
The J-LONG study suggested that correction by the physique was needed to interpret echocardiographic data of the elderly. Also, gender differences and age-related changes in cardiac morphology and function were observed, and further studies are needed to confirm the clinical significance.
Results date posted
| 2020 | Year | 10 | Month | 18 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
As of April 18, 2020,
The final paper has been accepted.
Currently waiting for the electronic version to be released.
Date of the first journal publication of results
| 2020 | Year | 04 | Month | 18 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 09 | Month | 23 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 30 | Day |
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
| 2020 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.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 |
Single case data URL
Value
https://center6.umin.ac.jp/ice/28104
