A Nation-wide Registry of Familial Hypercholesterolemia : Clinical Status in Turkey (A-HIT2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- number of patients receiving proper treatment for FH
研究概览
简要总结
A-HIT2, is also designed as a National FH registry. At least 1000 FH patients will be recruited from 30 outpatient clinics representing the 12 Nuts statistical Regions in Turkey proportional to the 2015 Turkey's Population distribution.[14] Both HeFH and HoFH patients are eligible for enrollment. Sites specialized on cardiology, internal medicine, and endocrinology were invited by the Turkish Society of Cardiology.
详细描述
At least 1000 FH patients will be recruited from 30 outpatient clinics representing the 12 Nuts statistical Regions in Turkey proportional to the 2015 Turkey's Population distribution. Both HeFH and HoFH patients are eligible for enrollment. Sites specialized on cardiology, internal medicine, and endocrinology were invited by the Turkish Society of Cardiology. The primary objective of this cross-sectional study, is to detect the clinical status and management of the patients diagnosed with FH in Turkey. The secondary objectives are; to detect the pattern of clinical presentation, to know the medication use, to define the clinical response to LLT, to evaluate the attainment of LDL-cholesterol goals and to identify resistance and/or intolerance to LLT. Defining the CV risk factors and approach to these factors by the physicians, and comparing the attitudes in different specialty groups (cardiology, endocrinology and internal medicine) are also among the secondary objectives of the registry. Eligibility for screening was defined as having LDL-cholesterol levels > 160 mg/dl either as on treatment or untreated values. Centers may enroll both incident and prevalent patients. The inclusion criteria included age > 18 years and being diagnosed as possible FH. The possible FH was defined as having a total score of > 2 according to Dutch lipid clinic network (DLCN) criteria. Patients with triglyceride levels > 400 mg/dl or secondary hyperlipidemia (ie, untreated hypothyroidism, nephrotic syndrome, cholestasis, etc..) will be excluded from the study. Two different data sets will be collected for A-HIT2. The physicians will complete electronic case report forms for each patient Patients will also complete a short survey to assess the level of disease awareness. This survey is also designed to give information on the patients' perceptions and knowledge on cholesterol, its harm, and LLT. All data will be collected in a single visit. Data verification will be based on the source document control of 5% sample randomly selected per center.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 18 years and being diagnosed as possible FH.
- •The possible FH was defined as having a total score of > 2 according to Dutch lipid clinic network (DLCN) criteria
排除标准
- •Patients with triglyceride levels > 400 mg/dl or secondary hyperlipidemia (ie, untreated hypothyroidism, nephrotic syndrome, cholestasis, etc..) will be excluded from the study.
结局指标
主要结局
number of patients receiving proper treatment for FH
时间窗: February- November 2017
how many patients are receieving the proper lipid lowering drugs for the diagnosis of FH
次要结局
- number of patients reaching LDL-cholesterol goal according to risk status (risk level)(February- November 2017)
研究者
Meral Kayikcioglu
Professor MD
Ege University
