A Prospective Cohort Study on Familial Hypercholesterolem... | NCT04958629

Studies
A Prospective Cohort Study on Familial Hypercholesterolemia in Health Examination Population

NCT04958629

Sponsor

Peking University Third Hospital

Status

Unknown status

Last Update Posted

Sep 20, 2021Actual

Enrollment

318Estimated

Phase

Not provided

Conditions

Familial Hypercholesterolemia

Interventions

familial hypercholesterolemia

Countries

Not provided

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

Jun 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2021Estimated

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Jun 27, 2021

First Submission Date that Met QC Criteria

Jul 8, 2021

First Posted Date

Jul 12, 2021Actual

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

Sep 16, 2021

Last Update Posted Date

Sep 20, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

To determine the prevalence and the prognosis in a corhort of patients with familial hypercholesterolemia (FH).

Detailed Description

This study aims to achieve the following goals through prospective cohort study and statistical analysis: (1) to determine the prevalence of familial hypercholesterolemia (FH) in healthy people with hypercholesterolemia.（2) Compared with non FH population, the relative risk of atherosclerotic cardiovascular disease (ASCVD) in FH patients in China was calculated, and the risk prediction model of ASCVD in FH patients was constructed by using biochemical results, imaging data, biomarkers and other indicators.（3) To evaluate the benefits of different lipid-lowering strategies for FH patients in China.（4) To analyze the gene carriers of FH patients in China.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

318Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
non-FH Group
FH Group			Other: familial hypercholesterolemia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
familial hypercholesterolemia	Other	Among the selected patients with hyperlipidemia, those who met the diagnostic criteria of FH were included in the study cohort as FH group.	FH Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with atherosclerotic cardiovascular disease (ASCVD) events	1) Fatal or non-fatal myocardial infarction; 2) Fatal or non-fatal ischemic stroke; 3) Coronary artery revascularization; 4) Peripheral artery revascularization; 5) Cardiogenic death	2 years from enrollmet

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1) Patients with definite diagnosis of hyperlipidemia.

Exclusion Criteria:

Age < 18.
Do not agree to participate in this study.
secondary hypercholesterolemia.
Phytosteronemia.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with hyperlipidemia were screened from health examination population. Among the selected patients with hyperlipidemia, those who met the following inclusion and exclusion criteria were included in the study cohort as FH group or non-FH group.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wei Gao, Doctor	Contact	+86 13901366179		weigao@bjmu.edu.cn

Overall Officials

Name	Affiliation	Role
Wei Gao, Doctor	Peking University Third Hospital	Study Chair

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006938	Hyperlipoproteinemia Type II

Ancestor Terms

ID	Term
D008052	Lipid Metabolism, Inborn Errors
D008661	Metabolism, Inborn Errors
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011973	Receptors, LDL

Ancestor Terms

ID	Term
D018110	Receptors, Lipoprotein
D011956	Receptors, Cell Surface
D008565	Membrane Proteins
D011506	Proteins

Browse Leaves

Not provided

Browse Branches

Not provided