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Trial record 12 of 75 for:    Recruiting, Not yet recruiting, Available Studies | "Hypercholesterolemia"

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

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ClinicalTrials.gov Identifier: NCT03398954
Recruitment Status : Recruiting
First Posted : January 16, 2018
Last Update Posted : March 12, 2018
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
China Cardiovascular Association

Brief 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.

Condition or disease
Familial Hypercholesterolemia

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1128 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Screening Out Rate and Clinical Management of Familial Hypercholesterolemia: a Prospective Pilot Study in China Outpatient Department
Actual Study Start Date : January 18, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. The screening out rate of FH [ Time Frame: 2 years ]
    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. The clinical characteristics of clinical diagnosed FH patients [ Time Frame: 2 years ]
    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

  3. The pharmaceutical therapy for clinical diagnosed FH patients [ Time Frame: 2 years ]
    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


Secondary Outcome Measures :
  1. LDL-C concentrations over time [ Time Frame: 2 years ]
    LDL-C level during the follow up period

  2. Use of lipid-modifying therapies over time [ Time Frame: 2 years ]
    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 during the follow up period

  3. Proportion of patients within and at distance from 2016 China guideline's LDL-C target [ Time Frame: 2 years ]
    Achievement of 2016 China guideline defined target LDL-C levels; <2.6mmol/L (high risk), <1.8mmol/L (very high risk)

  4. Incidence of cardiovascular event [ Time Frame: 2 years ]
    Incidence of cardiovascular event (CV death, all-cause mortality, non-fatal MI, non-fatal stroke)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability 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.
Criteria

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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03398954


Contacts
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Contact: huo yong, master 13901333060 drhuoyong@163.com
Contact: qi li tong, doctor 13671360078 qilitong2013@aliyun.com

Locations
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China, Beijing
Beijing Anzhen Hospital Recruiting
Beijing, Beijing, China
Contact: lvya wang         
Principal Investigator: lvya wang         
Sponsors and Collaborators
China Cardiovascular Association
Amgen
Investigators
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Principal Investigator: huo yong, master Peking University First Hospital

Additional Information:

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Responsible Party: China Cardiovascular Association
ClinicalTrials.gov Identifier: NCT03398954     History of Changes
Other Study ID Numbers: 20177276
First Posted: January 16, 2018    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyperlipoproteinemia Type II
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias