NCT03398954

Brief Summary

  • The screening out rate of clinical diagnosed familial hypercholesterolemia, with applying China recent issued FH screening protocol in subjects with LDL-C\>4.65mmol/L if statin naïve or LDL-C\>3.7mmol/L if on statin treatment in pilot outpatient department of China.
  • The clinical characteristics of clinical diagnosed FH patients(including HoFH and HeFH), including: demography, medical history, family history, sign and symptoms, lab testing and cardiovascular imagine result.
  • The pharmaceutical therapy for clinical diagnosed FH patients (including HoFH and HeFH), including the type of medication, proportion for each medication, dosage and treatment duration.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,128

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2017

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 16, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

January 18, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

March 12, 2018

Status Verified

January 1, 2018

Enrollment Period

1.9 years

First QC Date

December 20, 2017

Last Update Submit

March 8, 2018

Conditions

Familial Hypercholesterolemia

Outcome Measures

Primary Outcomes (3)

  • The screening out rate of FH

    The screening out rate of clinical diagnosed familial hypercholesterolemia, with applying China recent issued FH screening protocol in subjects with LDL-C\>4.65mmol/L if statin naïve or LDL-C\>3.7mmol/L if on statin treatment in pilot outpatient department of China.

    2 years

  • The clinical characteristics of clinical diagnosed FH patients

    The clinical characteristics of clinical diagnosed FH patients(including HoFH and HeFH), including: demography, medical history, family history, sign and symptoms, lab testing and cardiovascular imagine result

    2 years

  • The pharmaceutical therapy for clinical diagnosed FH patients

    The pharmaceutical therapy for clinical diagnosed FH patients (including HoFH and HeFH), including the type of medication, proportion for each medication, dosage and treatment duration

    2 years

Secondary Outcomes (4)

  • LDL-C concentrations over time

    2 years

  • Use of lipid-modifying therapies over time

    2 years

  • Proportion of patients within and at distance from 2016 China guideline's LDL-C target

    2 years

  • Incidence of cardiovascular event

    2 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

For the primary objective the study population will comprise all patients with a documented LDL-C\>4.65mmol/L if statin naïve and LDL-C\>3.7mmol/L if on statin treatment before enrollment in the outpatient department of pilot hospitals from Sept. 2017-Sept. 2019.

You may qualify if:

  • Written inform consent provided.
  • Male and female cardiovascular outpatients and inpatients with LDL-C\>4.65mmol/L if statin naïve or LDL-C\>3.7mmol/L if on statin treatment before enrollment during Sept.2017 to Sept. 2019.

You may not qualify if:

  • Subjects who cannot understand study procedure
  • Subjects diagnosed as secondary dyslipidemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

RECRUITING

Related Publications (1)

  • Qureshi N, Da Silva MLR, Abdul-Hamid H, Weng SF, Kai J, Leonardi-Bee J. Strategies for screening for familial hypercholesterolaemia in primary care and other community settings. Cochrane Database Syst Rev. 2021 Oct 7;10(10):CD012985. doi: 10.1002/14651858.CD012985.pub2.

    PMID: 34617591DERIVED

MeSH Terms

Conditions

Hyperlipoproteinemia Type II

Condition Hierarchy (Ancestors)

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

Study Officials

  • huo yong, master

    Peking University First Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

huo yong, master

CONTACT

13901333060drhuoyong@163.com

qi li tong, doctor

CONTACT

13671360078qilitong2013@aliyun.com

Study Design

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

Study Record Dates

First Submitted

December 20, 2017

First Posted

January 16, 2018

Study Start

January 18, 2018

Primary Completion

December 30, 2019

Study Completion

December 30, 2019

Last Updated

March 12, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)