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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 |
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 |
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Condition | |||||
Condition | Chronic obstructive pulmonary disease | ||||
Classification by specialty |
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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 | |
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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 |
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Age-upper limit |
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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. |
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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 |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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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 |
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Last modified on |
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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 |