UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048551 |
|---|---|
| Receipt number | 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 15:32:51 |
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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
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
khamada@yamaguchi-u.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine and Infectious Disease, Yamaguchi University Hospital
Institute
Department
Personal name
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
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
Value
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 | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
