Screening Out Rate and Clinical Management of Familial Hypercholesterolemia： a Prospective Pilot Study in China Outpatient Department
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,128
- 试验地点
- 1
- 主要终点
- The screening out rate of FH
研究概览
简要总结
- 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.
- 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.
- 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.
详细描述
- Objective 1.1.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.
1.2.Secondary Objective To describe parameters related to clinical management of diagnosed FH, including patient demographics and characteristics, LDL-C and triglyceride concentrations, use of lipid modifying therapies, and outcomes over time.
1.3.Exploratory To describe how China FH screening protocol fits in the practice when compared with DLCN.
To explore the multi-disciplinary practical pattern of FH patient management 2. Endpoint(s)/Outcome(s) Assessment 2.1.Endpoint(s) 2.1.1.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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Subjects who cannot understand study procedure
- •Subjects diagnosed as secondary dyslipidemia
结局指标
主要结局
The screening out rate of FH
时间窗: 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.
The clinical characteristics of clinical diagnosed FH patients
时间窗: 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
The pharmaceutical therapy for clinical diagnosed FH patients
时间窗: 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
次要结局
- 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)