DyslipidemiasKORLIPIDNCT05221528
Association Between Lipid Profiles and Cardiovascular Events
An observational study of Dyslipidemias and Cardiovascular Diseases, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
KORLIPID (Study on the Association between Lipid Profiles and Cardiovascular Events) registry enrolled 4234339 subjects who underwent general health check-ups provided by National Health Insurance Service in 2009. Read more about this study
- Who is it for?
- Ages 30 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemias, Cardiovascular Diseases
- What is being tested?
- Measurement of lipid profiles
- How many people
- 4,234,339 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Jan 2021to 6 Jan 2023
- 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 30 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects (age 30-74 years) who underwent general health check-ups in 2009
Who may be able to join
- Subjects who underwent general health check-ups in 2009
Who cannot join
- Age less than 30 years
- Age 75 years or more
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on the Association Between Lipid Profiles and Cardiovascular Events: Analysis From the Korean Nationwide Health Insurance Database
KORLIPID (Study on the Association between Lipid Profiles and Cardiovascular Events) registry enrolled 4234339 subjects who underwent general health check-ups provided by National Health Insurance Service in 2009.
Read the detailed description
Subjects who underwent general health check-ups provided by National Health Insurance Service in 2009 were included in KORLIPID study. Demographic data, anthropometric data and medical information from general health check-ups were collected. In addition, medical records in National Health Insurance Service between 2002 and 2018 were also collected.
- Conditions
- Dyslipidemias, Cardiovascular Diseases
- Being tested
- Measurement of lipid profiles
- Medical subject headings
- Dyslipidemias, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of lipid profilesDiagnostic test
Measured: total cholesterol, high-density lipoprotein cholesterol, and triglyceride Calculated: low-density lipoprotein
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial infarction
acute myocardial infarction demanding hospitalization
Measured: until 2018 after inclusion
Secondary outcomes (3)
Stroke
acute ischemic stroke demanding hospitalization
Measured: until 2018 after inclusion
Heart failure
acute heart failure demanding hospitalization
Measured: until 2018 after inclusion
Death
all cause mortality
Measured: until 2018 after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start6 Jan 2021
- Primary completion15 Oct 2021
- Study completion6 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- 4,234,339 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han-Mo Yang, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221528
- Sponsor's protocol ID
- E-2101-012-1184
- Acronym
- KORLIPID
- Status last verified
- Feb 2022
- First submitted
- 28 Oct 2021
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: For reasonable request, data are available through approval and oversight by the Korean national health insurance service.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Association Between Lipid Profiles and Cardiovascular Events: Analysis From the Korean Nationwide Health Insurance Database
- ClinicalTrials.gov ID
- NCT05221528
- Acronym / sponsor ID
- KORLIPID / E-2101-012-1184
- Conditions
- Dyslipidemias, Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,234,339 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 6 Jan 2023 (estimated)
- First posted
- 3 Feb 2022 (actual)
- 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.
KORLIPID (Study on the Association between Lipid Profiles and Cardiovascular Events) registry enrolled 4234339 subjects who underwent general health check-ups provided by National Health Insurance Service in 2009.
Detailed description
Subjects who underwent general health check-ups provided by National Health Insurance Service in 2009 were included in KORLIPID study. Demographic data, anthropometric data and medical information from general health check-ups were collected. In addition, medical records in National Health Insurance Service between 2002 and 2018 were also collected.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 30 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects (age 30-74 years) who underwent general health check-ups in 2009
Key inclusion criteria (1 listed)
- Subjects who underwent general health check-ups in 2009
Key exclusion criteria (2 listed)
- Age less than 30 years
- Age 75 years or more
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of lipid profilesMeasured: total cholesterol, high-density lipoprotein cholesterol, and triglyceride Calculated: low-density lipoprotein | Diagnostic test | – |
Primary outcome
Myocardial infarction
Time frame: until 2018 after inclusion
acute myocardial infarction demanding hospitalization
3 secondary outcomes
Stroke
Time frame: until 2018 after inclusion
Heart failure
Time frame: until 2018 after inclusion
Death
Time frame: until 2018 after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
- Individual participant dataSharing planned: Yes. For reasonable request, data are available through approval and oversight by the Korean national health insurance service.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Dyslipidemias and Cardiovascular Diseases, run by Seoul National University Hospital 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 2 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 3 Feb 2022. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial infarction (time frame: until 2018 after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Feb 2022.