NCT04958629

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
318

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 12, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 20, 2021

Status Verified

June 1, 2021

Enrollment Period

2.2 years

First QC Date

June 27, 2021

Last Update Submit

September 16, 2021

Conditions

Familial Hypercholesterolemia

Keywords

familial hypercholesterolemiaprognosis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

non-FH Group

FH Group

Other: familial hypercholesterolemia

Interventions

familial hypercholesterolemiaOTHER

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • \) Patients with definite diagnosis of hyperlipidemia.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hyperlipoproteinemia Type II

Interventions

Receptors, LDL

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperlipoproteinemiasHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Receptors, LipoproteinReceptors, Cell SurfaceMembrane ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Wei Gao, Doctor

    Peking University Third Hospital

    STUDY CHAIR

Central Study Contacts

Wei Gao, Doctor

CONTACT

+86 13901366179weigao@bjmu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2021

First Posted

July 12, 2021

Study Start

October 1, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

September 20, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share