UMIN-CTR Clinical Trial

Public title

Clinical Deep Data Accumulation System

Acronym

CLIDAS

Scientific Title

Clinical Deep Data Accumulation System

Scientific Title:Acronym

CLIDAS

Region

Japan

Condition

Ischemic heart disease, heart failure, and hypertension

Classification by specialty

Medicine in general	Cardiology	Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To extract data from electronic medical record systems and departmental systems at each institution for patients with ischemic heart disease and heart failure and analyze them in combination with outcome data to explore the actual practice of patients with ischemic heart disease and heart failure and the factors that influence outcomes.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Cost-effectiveness analysis of treatment for patients with ischemic heart disease and heart failure

Key secondary outcomes

Analysis of Factors Affecting Outcomes After Treatment of Patients with Ischemic Heart Disease and Heart Failure
Analysis of clinical questions emanating from clinical practice

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who visit the cardiology department of the participating facilities

Key exclusion criteria

None

Target sample size

30000

Name of lead principal investigator

1st name	RYOZO
Middle name
Last name	NAGAI

Organization

Jichi Medical University

Division name

President

Zip code

329-0498

Address

3311-1 Yakushiji, Shimotsuke city, Tochigi Pref. JAPAN

TEL

0285-44-2111

Email

nagai-tky@umin.ac.jp

Name of contact person

1st name	HIDEO
Middle name
Last name	Fujita

Organization

Jichi Medical University Saitama Medical Center

Division name

Division of Cardiology, the first department of general medical school

Zip code

330-8503

Address

1-847 Amanuma-cho, Omiya-ku, Saitama city, Saitama pref.

TEL

048-647-2111

Homepage URL

Email

hideofujita@jichi.ac.jp

Institute

Jichi Medical University

Institute

Department

Personal name

Organization

Cabinet Office, Government of Japan

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

JAPAN

Co-sponsor

Name of secondary funder(s)

Organization

The comittee of ehics, Jichi Medical University

Address

3311-1 Yakushiji, Shimotsuke city, Tochigi Pref.

Tel

0285-44-2111

Email

rinri@jichi.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2025

Year

03

Month

19

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2016

Year

07

Month

01

Day

Date of IRB

2022

Year

07

Month

29

Day

Anticipated trial start date

2016

Year

07

Month

29

Day

Last follow-up date

2026

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

To examine the problems in automatically registering data on patients with ischemic heart disease and heart failure in the MCDRS via SS-MIX, and to analyze the registered data to verify the cost-effectiveness of treatment.
This is a multi-institutional, backward-looking, observational study (case accumulation), and the databases constructed by extracting information from the electronic medical records of each institution will be integrated and used for analysis of cardiovascular diseases.
After exporting the electronic medical record data of Jichi Medical University Hospital into SS-MIX format, the investigators intended to register the data in MCDRS and analyze the registered data for ischemic heart disease and heart failure patients hospitalized in the Department of Cardiology from April 2013 to December 2014 (at the time of initial application for this study). The data was to be registered in the MCDRS and analyzed (at the time of the initial application for the study).
Subsequently, in order to further increase the volume of data and improve the quality of the analysis, additional subjects were added to the registry, and approval has now been granted for cases up to March 31, 2026.
After anonymization of the data, the data from the collaborating institutions will be combined with DPC and receipt data to determine what factors influenced ischemic heart disease and heart failure, as well as the cost-effectiveness of treatment. Anonymization will be done by replacing IDs and erasing names.

Registered date

2025

Year

03

Month

19

Day

Last modified on

2025

Year

03

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064835