UMIN-CTR Clinical Trial

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Name
UMIN ID

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000048551
Receipt No. R000054520
Scientific Title Prediction of cardiovascular events in chronic obstructive pulmonary disease using a machine learning approach
Date of disclosure of the study information 2022/08/02
Last modified on 2022/08/02

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Basic information
Public title Prediction of cardiovascular events in chronic obstructive pulmonary disease using a machine learning approach
Acronym Prediction of CV events in COPD using machine learning
Scientific Title Prediction of cardiovascular events in chronic obstructive pulmonary disease using a machine learning approach
Scientific Title:Acronym Prediction of CV events in COPD using machine learning
Region
Japan

Condition
Condition Chronic obstructive pulmonary disease
Classification by specialty
Medicine in general Cardiology Pneumology
Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To predict cardiovascular events (defined as the incidence of myocadiac infarction, angina, heart failure, arrhythmia, stroke and transient ischemic attack) in COPD patients by using machine learning.
Basic objectives2 Others
Basic objectives -Others To identify predictors for CV events in COPD patients using machine learning approach.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The accuracy of machine learning algorithm to predict CV events in COPD patients.
Key secondary outcomes Predictors of CV events identified using machine learning techniques.

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Having International Classification of Disease, 10th revision [ICD-10] codes for COPD (J41-44) at least once in Sado-Himawari Network, which is the electronic health record (EHR) system in Sado city, Niigata prefecture, Japan.
2. Patients are regardless of inpatients or outpatients.
Key exclusion criteria Patients with less than 180 days of follow-up in Sado-Himawari Network.
Target sample size 1700

Research contact person
Name of lead principal investigator
1st name Kazuto
Middle name
Last name Matsunaga
Organization Yamaguchi University Hospital
Division name Respiratory Medicine and Infectious Disease
Zip code 755-8505
Address 1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan
TEL 0836-85-3123
Email kazmatsu@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name Kazuki
Middle name
Last name Hamada
Organization Yamaguchi University Hospital
Division name Department of Respiratory Medicine and Infectious Disease
Zip code 755-8505
Address 1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan
TEL 0836-85-3123
Homepage URL
Email khamada@yamaguchi-u.ac.jp

Sponsor
Institute Department of Respiratory Medicine and Infectious Disease, Yamaguchi University Hospital
Institute
Department

Funding Source
Organization AstraZeneca PLC
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor 1. The Council of Sado Regional Health Care
2. Department of Systems Bioinformatics, Graduate School of Medicine, Yamaguchi University
3. AI Systems Medicine Research and Training Center (AISMEC), Graduate School of Medicine, Yamaguchi University and Yamaguchi University Hospital
4. Department of Pulmonary and Gerontology, Graduate School of Medicine, Yamaguchi University
Name of secondary funder(s)

IRB Contact (For public release)
Organization Center For Clinical Research, Yamaguchi Univesity Hospital
Address 1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan
Tel 0836-22-2428/+81-836-85-3123
Email me223@yamaguchi-u.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 ESR-21-21503
Org. issuing International ID_1 AstraZeneca PLC
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2022 Year 08 Month 02 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 Open public recruiting
Date of protocol fixation
2022 Year 05 Month 10 Day
Date of IRB
2022 Year 06 Month 02 Day
Anticipated trial start date
2022 Year 06 Month 02 Day
Last follow-up date
2022 Year 06 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information For convenience, the anticipated trial start date and last follow-up date are registered as the same date due to retrospective and observational design.

Management information
Registered date
2022 Year 08 Month 02 Day
Last modified on
2022 Year 08 Month 02 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054520

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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