UMIN-CTR Clinical Trial

Basic information
Public title	Relationship of skeletal muscle mass index (SMI), mustle mass in the lower limb using bioelectrical impedance analysis and frailty status
Acronym	Skeletal mustle mass and frailty
Scientific Title	Relationship of skeletal muscle mass index (SMI), mustle mass in the lower limb using bioelectrical impedance analysis and frailty status
Scientific Title:Acronym	Skeletal mustle mass and frailty
Region	Japan

Condition
Condition	Cardiovascular disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the relationship between skeletal muscle mass index (SMI), muscle mass in the lower limb measured using bioelectrical impedance analysis (BIA) and frailty status in patients with cardiovascular disease
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Correlation between skeletal muscle mass index (SMI), muscle mass in the lower limb measured using bioelectrical impedance analysis (BIA) and frailty status
Key secondary outcomes	1. Assessment of cut-off value, sensitivity and specificity of skeletal muscle mass index (SMI) and muscle mass in the lower limb for the diagnosis of frailty status 2. Relationship of frailty status, skeletal muscle mass index (SMI) and muscle mass in the lower limb and in-hospital episode of fall or delirium or later major adverse outcomes (all cause death and heart failure-related admission)

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	No need to know

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Measurement of skeletal muscle mass index (SMI) and muscle mass in the lower limb using bioelectrical impedance analysis (BIA) and evaluation of frailty status using four scales (The Edmonton Frail Score, SHARE-FI, Frailty Screening Index, Clinical Frailty Scale) in hospitalized patients with cardiovascular disease
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	Patients required hospitalization due to cardiovascular disease
Key exclusion criteria	1. Patients with pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devise 2. Inadequate patients by physician's discresion
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Kei Middle name Last name Yunoki
Organization	Tsuyama Chuo Hospital
Division name	Department of Cardiology
Zip code	708-0841
Address	1756, Kawasaki, Tsuyama-City, Okayama, Japan
TEL	0868218111
Email	kei.yunoki@gmail.com

Public contact
Name of contact person	1st name Kei Middle name Last name Yunoki
Organization	Tsuyama Chuo Hospital
Division name	Department of Cardiology
Zip code	708-0841
Address	1756, Kawasaki, Tsuyama-City, Okayama, Japan
TEL	0868218111
Homepage URL	http://www.tch.or.jp/clinical_research.html
Email	hee0409@gmail.com

Sponsor
Institute	Department of Cardiology, Tsuyama Chuo Hospital
Institute
Department

Funding Source
Organization	Department of Cardiology, Tsuyama Chuo Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Department of Cardiology, Tsuyama Chuo Hospital
Address	1756, Kawasaki, Tsuyama-City, Okayama, Japan
Tel	0868218111
Email	ando11@tch.or.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	2017 Year 12 Month 19 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	No longer recruiting
Date of protocol fixation	2017 Year 09 Month 25 Day
Date of IRB	2017 Year 09 Month 06 Day
Anticipated trial start date	2017 Year 10 Month 01 Day
Last follow-up date	2019 Year 12 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 12 Month 19 Day
Last modified on	2019 Year 12 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034699