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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000022217
Receipt No. R000025593
Scientific Title Associations of Subclinical Cardiac Dysfunction with Frailty using Speckle Tracking Echocardiography
Date of disclosure of the study information 2016/06/01
Last modified on 2019/11/08

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Basic information
Public title Associations of Subclinical Cardiac Dysfunction with Frailty using Speckle Tracking Echocardiography
Acronym Frail and Echocardiography
Scientific Title Associations of Subclinical Cardiac Dysfunction with Frailty using Speckle Tracking Echocardiography
Scientific Title:Acronym Frail and Echocardiography
Region
Japan

Condition
Condition Patients with echocardiography
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the relationship between frailty and echocardiograhic variables
To assess the prognostic value of frail and echocardiographic variables
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Frail score
Majour cardiovascular events
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
18 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Patients who underwent echocardiography
Key exclusion criteria No comittment
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenya Kusunose
Organization Tokushima University Hospital
Division name Cardiovascular Medicine
Zip code
Address Tokushima City Kuramoto 3-18-15
TEL 088-633-7851
Email kusunosek@tokushima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Clinical Trial Center For Development Therapeutics
Organization Tokushima University Hospital
Division name Clinical Trial Center
Zip code
Address Tokushima City Kuramoto 2-50-1
TEL 088-633-9294
Homepage URL
Email awachiken@tokushima-u.ac.jp

Sponsor
Institute Tokushima University Hospital
Institute
Department

Funding Source
Organization Tokushima University Hospital
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
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 06 Month 01 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 Preinitiation
Date of protocol fixation
2016 Year 05 Month 06 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 01 Day
Last follow-up date
2018 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2018 Year 12 Month 01 Day

Other
Other related information None

Management information
Registered date
2016 Year 05 Month 06 Day
Last modified on
2019 Year 11 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025593

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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