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a Prospective Pilot Study of Screening Out Rate and Clinical Management of Familial Hypercholesterolemia

NCT03398954 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1128

Last updated 2018-03-12

No results posted yet for this study

Summary

1. Primary Objective To estimate the prevalence of clinical diagnosed familial hypercholesterolemia, as well as the clinical characteristics and current treatment, with applying China recent issued FH screening protocol in pilot outpatient department of China.
2. Study Design The study is a prospective observational research study of clinical diagnoses FH patients in outpatient department in pilot hospitals to evaluate the screening out rate and the clinical feature and management of FH patients including HoFH, with applying China recent issued FH screening protocol.
3. Eligibility 3.1.Inclusion Criteria 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.

3.2Exclusion Criteria Subjects who cannot understand study procedure Subjects diagnosed as secondary dyslipidemia
4. Primary Endpoint

* 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.

Conditions

  • Familial Hypercholesterolemia

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • China Cardiovascular Association

    lead OTHER

Principal Investigators

  • huo yong, master · Peking University First Hospital

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-18
Primary Completion
2019-12-30
Completion
2019-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03398954 on ClinicalTrials.gov