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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000018472
Receipt No. R000021392
Scientific Title Multidisciplinary heart team approach to fraility and sarcopenia in patients with cardiovascular disease.
Date of disclosure of the study information 2015/08/01
Last modified on 2015/07/29

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Basic information
Public title Multidisciplinary heart team approach to fraility and sarcopenia in patients with cardiovascular disease.
Acronym Fraility and sarcopenia in patients with cardiovascular disease.
Scientific Title Multidisciplinary heart team approach to fraility and sarcopenia in patients with cardiovascular disease.
Scientific Title:Acronym Fraility and sarcopenia in patients with cardiovascular disease.
Region
Japan

Condition
Condition cardiovascular disease
heart failure
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Despite advances in pharmacologic and device therapy, it remains unknown how to evaluate fraility and sarcopenia in patients with cardiovasular desease. In the present study, we aim to evaluate the usefullness of the heart team approach for the assessment of fraility and sarcopenia in patients with cardiovascular disease.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes all-cause death
heart failure admission
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment Other
Interventions/Control_1 Questionnaire for nursing care prevention.
Assessment of physical ability using SPBB.
Evaluation of body water and muscle using Inbody.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria All hospitalized patients with cardiovascular disease.
Key exclusion criteria Patients who admit due to routine test.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masanobu Miura
Organization Tohoku University Graduate School of Medicine
Division name Department of Evidence-Based Cardiovascular Medicine
Zip code
Address 1-1 Seiryomachi, Aoba-ku, Sendai, Japan 980-8574
TEL 022-717-7153
Email masa-miura@cardio.med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masanobu Miura
Organization Tohoku University Graduate School of Medicine
Division name Department of Evidence-Based Cardiovascular Medicine
Zip code
Address 1-1 Seiryomachi, Aoba-ku, Sendai, Japan 980-8574
TEL 022-717-7153
Homepage URL
Email masa-miura@cardio.med.tohoku.ac.jp

Sponsor
Institute Department of cardiovascular medicine, Tohoku university.
Institute
Department

Funding Source
Organization donation
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
2015 Year 08 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
2015 Year 07 Month 26 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 07 Month 29 Day
Last modified on
2015 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021392

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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