Cardiovascular DiseaseNCT02931500
Machine Learning for Identification of Future Disease Development: A Nationwide Cohort Study (MILESTONE)
An observational study of Cardiovascular Disease and Metabolic Disease, run by Yonsei University at 1 site in South Korea.
Trial summary
To develop machine learning algorithms for the identification of future development of cardiovascular and metabolic disease Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease, Metabolic Disease
- How many people
- 510,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2016to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The data which is health checkup record about 510,000 Subjects between 2002 and 2013 from National Health Insurance Service (NHIS) in South Korea.
Who may be able to join
- The Subject who is got health checkup between 2002 and 2013, and had been recorded the health checkup result to the National Health Insurance Service(NHIS) in South Korea.
Who cannot join
- Persons whose disease development is not identified from the records due to emigration or disappearance
Trial locations and contacts
1 site in 1 country.
Hyuk-Jae Chang, PhD contact
In-Jeong Cho contact
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Severance Hospital
Seoul, 102-752
Hyuk-Jae Chang, MD, 82-2-2228-8454, hjchang@yuhs.ac
About this study
Official title: MachIne LEarning for Identification of Future Development of cardiovaScular and meTabOlic Disease: a NationwidE Time-series Cohort Study (MILESTONE)
To develop machine learning algorithms for the identification of future development of cardiovascular and metabolic disease
Read the detailed description
The MILESTONE trial is retrospective and data review study with health checkup data from the National Health Insurance Services(NHIS) in Korea. The data will be included general health examination for individuals , type of health insurance, medical bill details, medical histories, treatment and prescriptions about 514,795 individuals who were over 40 years old.
- Conditions
- Cardiovascular Disease, Metabolic Disease
- Keywords
- machine learning, cohort study
- Medical subject headings
- Cardiovascular Diseases, Metabolic Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy in prediction of development of cardiovascular and metabolic disease using machine learning algorithm
Measured: 6months
Secondary outcomes (2)
Accuracy in prediction of development of cardiovascular and metabolic disease using logistic regression analysis
Measured: 6months
Accuracy in prediction of development of cardiovascular and metabolic disease using Framingham risk score
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study start1 Jul 2016
- Primary completion30 Oct 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 510,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyuk-Jae Chang, Yonsei University
- Investigators
- Hyuk-Jae Chang, PhD, Principal investigator, Yonsei Univerity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02931500
- Sponsor's protocol ID
- 4-2016-0383
- Status last verified
- Jan 2018
- First submitted
- 21 Jul 2016
- Last updated
- 10 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Cho IJ, Sung JM, Kim HC, Lee SE, Chae MH, Kavousi M, Rueda-Ochoa OL, Ikram MA, Franco OH, Min JK, Chang HJ. Development and External Validation of a Deep Learning Algorithm for Prognostication of Cardiovascular Outcomes. Korean Circ J. 2020 Jan;50(1):72-84. doi: 10.4070/kcj.2019.0105. Epub 2019 Aug 19.
PubMed 31456363Cho IJ, Sung JM, Chang HJ, Chung N, Kim HC. Incremental Value of Repeated Risk Factor Measurements for Cardiovascular Disease Prediction in Middle-Aged Korean Adults: Results From the NHIS-HEALS (National Health Insurance System-National Health Screening Cohort). Circ Cardiovasc Qual Outcomes. 2017 Nov;10(11):e004197. doi: 10.1161/CIRCOUTCOMES.117.004197.
PubMed 29150537
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MachIne LEarning for Identification of Future Development of cardiovaScular and meTabOlic Disease: a NationwidE Time-series Cohort Study (MILESTONE)
- ClinicalTrials.gov ID
- NCT02931500
- Acronym / sponsor ID
- 4-2016-0383
- Conditions
- Cardiovascular Disease, Metabolic Disease
- Keywords
- machine learning, cohort study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 510,000 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 30 Oct 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 13 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To develop machine learning algorithms for the identification of future development of cardiovascular and metabolic disease
Detailed description
The MILESTONE trial is retrospective and data review study with health checkup data from the National Health Insurance Services(NHIS) in Korea. The data will be included general health examination for individuals , type of health insurance, medical bill details, medical histories, treatment and prescriptions about 514,795 individuals who were over 40 years old.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The data which is health checkup record about 510,000 Subjects between 2002 and 2013 from National Health Insurance Service (NHIS) in South Korea.
Key inclusion criteria (1 listed)
- The Subject who is got health checkup between 2002 and 2013, and had been recorded the health checkup result to the National Health Insurance Service(NHIS) in South Korea.
Key exclusion criteria (1 listed)
- Persons whose disease development is not identified from the records due to emigration or disappearance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy in prediction of development of cardiovascular and metabolic disease using machine learning algorithm
Time frame: 6months
2 secondary outcomes
Accuracy in prediction of development of cardiovascular and metabolic disease using logistic regression analysis
Time frame: 6months
Accuracy in prediction of development of cardiovascular and metabolic disease using Framingham risk score
Time frame: 6months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2018.
- Derived from this study: PubMed 31456363Cho IJ, Sung JM, Kim HC, Lee SE, Chae MH, Kavousi M, Rueda-Ochoa OL, Ikram MA, Franco OH, Min JK, Chang HJ. Development and External Validation of a Deep Learning Algorithm for Prognostication of Cardiovascular Outcomes. Korean Circ J. 2020 Jan;50(1):72-84. doi: 10.4070/kcj.2019.0105. Epub 2019 Aug 19.
- Derived from this study: PubMed 29150537Cho IJ, Sung JM, Chang HJ, Chung N, Kim HC. Incremental Value of Repeated Risk Factor Measurements for Cardiovascular Disease Prediction in Middle-Aged Korean Adults: Results From the NHIS-HEALS (National Health Insurance System-National Health Screening Cohort). Circ Cardiovasc Qual Outcomes. 2017 Nov;10(11):e004197. doi: 10.1161/CIRCOUTCOMES.117.004197.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyuk-Jae Chang, PhD contact
In-Jeong Cho contact
Hyuk-Jae Chang, PhD principal investigator
Yonsei Univerity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease and Metabolic Disease, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyuk-Jae Chang, PhD (hjchang@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy in prediction of development of cardiovascular and metabolic disease using machine learning algorithm (time frame: 6months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02931500, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2018; AzTrials last refreshed its copy on 5 Nov 2026.