UMIN-CTR Clinical Trial

Basic information
Public title	Low Activities of Daily Living Associated with Increased Cardiovascular Disease Mortality in Japan: An Analysis of Health Records from a Nationwide Claim-Based Database, JROAD-DPC
Acronym	Clinical impact of activities of daily living
Scientific Title	Low Activities of Daily Living Associated with Increased Cardiovascular Disease Mortality in Japan: An Analysis of Health Records from a Nationwide Claim-Based Database, JROAD-DPC
Scientific Title:Acronym	Clinical impact of activities of daily living
Region	Japan

Condition
Condition	acute coronary disease heart failure aortic disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To perform a nationwide claim survey using the DPC discharge database and to reveal the clinical impact of basal ADL on the prognosis of patients with cardiovascular diseases in a super-aged society.
Basic objectives2	Others
Basic objectives -Others	To investigate clinilal impact of ADL
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	in-hospital mortality 30-day mortality 7-day mortality
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
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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	acute coronary syndrome heart failure aortic disease
Key exclusion criteria	scheduled admissions
Target sample size	200000

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masaomi Gohbara
Organization	Saiseikai Yokohamashi Nanbu Hospital
Division name	Division of cardiology
Zip code
Address	3-2-10, Kounandai, Kounan-ku, Yokohama, Japan
TEL	045-832-1111
Email	gocchi3@hotmail.com

Public contact
Name of contact person	1st name Middle name Last name Masaomi Gohbara
Organization	Saiseikai Yokohamashi Nanbu Hospital
Division name	Division of cardiology
Zip code
Address	3-2-10, Kounandai, Kounan-ku, Yokohama, Japan
TEL	045-832-1111
Homepage URL
Email	gocchi3@hotmail.com

Sponsor
Institute	Saiseikai Yokohamashi Nanbu Hospital
Institute
Department

Funding Source
Organization	Yokohama City University
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	2018 Year 05 Month 23 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	206643
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	Completed
Date of protocol fixation	2017 Year 08 Month 08 Day
Date of IRB	2017 Year 08 Month 08 Day
Anticipated trial start date	2017 Year 08 Month 08 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The Japanese Registry of All Cardiac and Vascular Diseases (JROAD) was launched in 2004 to assess the clinical activity of each Japanese institution with cardiovascular beds. The Japanese Circulation Society publicly advertised for the research proposal using the JROAD and the JROAD-DPC. The present study was adopted as the 2016 research proposal (approval number: 2016-12-02).

Management information
Registered date	2018 Year 05 Month 23 Day
Last modified on	2019 Year 11 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037281