Association Between Lipid Profiles and Cardiovascular Events | NCT05221528

Studies
Association Between Lipid Profiles and Cardiovascular Events

NCT05221528

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Feb 3, 2022Actual

Enrollment

4,234,339Actual

Phase

Not provided

Conditions

Dyslipidemias
Cardiovascular Diseases

Interventions

Measurement of lipid profiles

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 6, 2021Actual

Primary Completion Date

Oct 15, 2021Actual

Completion Date

Jan 6, 2023Estimated

First Submitted Date

Oct 28, 2021

First Submission Date that Met QC Criteria

Feb 2, 2022

First Posted Date

Feb 3, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 2, 2022

Last Update Posted Date

Feb 3, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4,234,339Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Measurement of lipid profiles	Diagnostic Test	Measured: total cholesterol, high-density lipoprotein cholesterol, and triglyceride Calculated: low-density lipoprotein

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Myocardial infarction	acute myocardial infarction demanding hospitalization	until 2018 after inclusion

Secondary Outcomes

Measure	Description	Time Frame
Stroke	acute ischemic stroke demanding hospitalization	until 2018 after inclusion
Heart failure	acute heart failure demanding hospitalization

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects who underwent general health check-ups in 2009

Exclusion Criteria:

Age less than 30 years
Age 75 years or more

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

74 Years

Standard Ages

AdultOlder Adult

Study Population

Subjects (age 30-74 years) who underwent general health check-ups in 2009

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul		03080	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

For reasonable request, data are available through approval and oversight by the Korean national health insurance service.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D050171	Dyslipidemias
D002318	Cardiovascular Diseases

Ancestor Terms

ID	Term
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided