Can Biochemistry Interpretive Comments on Elevated Cholesterol Levels, Increase Referrals to Lipid Clinics and Detection Rate of Familial Hypercholesterolemia? A Step Wedge Cluster Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Number of patients reffered to lipid clinic
研究概览
简要总结
Familial hypercholesterolemia is the most common inherited disease of the lipid metabolism, however it remains underdiagnosed. Only 15 % of 30.000 possible patients have been found in Denmark. This quality assessing project will through a step wedge cluster randomized controlled trial evaluate establishment of a biochemistry interpretive comment on elevated LDL-C levels. The study will test if the comment results in an increase in referred patients to the lipid clinics of Southern Denmark as the primary endpoint, and as the secondary endpoint in more patients diagnosed with familial hypercholesterolemia. The project will run in totally 52 weeks and will in steps initiate the comment from the different laboratories in the Region of Southern Denmark.
详细描述
Introduction:
Familial hypercholesterolemia (FH) is the most common inherited disease of the lipid metabolism with a prevalence of approximately 1/200. It is estimated that only 15 % of the estimated 30.000 patients in Denmark has been diagnosed. With high risk of atherosclerotic coronary disease, it is estimated that there is a great potential regarding cardiovascular health and health economics by early initiation of lipid lowering treatment and cascade screening of families.
All doctors can refer to lipid clinics on the suspicion of FH. FH should be suspected when low-density lipoprotein - cholesterol (LDL-C) is extremely elevated without any other explanation in young individuals, or in families with premature cardiovascular disease. The diagnosis is made from clinical scoring systems as the Simon Broome criteria, Dutch Lipid Clinical Network criteria and the MEDPED criteria including genetic test. The treatment is lipid-lowering drugs including statins, ezetimibe and PCSK9-inhibitor in case of insufficient effect.
In the last 12-14 years systematic cascade screening of FH families have been used in Denmark to track and find FH patients. The patients have since 2020 been registered in the National clinical quality database for FH.
However FH remains an under diagnosed disease, resulting in premature ischemic cardiovascular disease and premature cardiovascular death. Thus, there is a need for optimized screening for FH and more projects are already initiated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Screening
- 盲法
- None
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
- •All referred patients to the lipid clinics of Southern Denmark
- •LDL-C ≥ 4 mmol/L in persons under the age of
- •LDL-C ≥ 5 mmol/L in persons ≥ 40 years.
排除标准
- •Pregnancy and Secondary dyslipidemia
- •Dysregulated diabetes. Hba1C < 48
- •Dysregulated hypothyreosis. Elevated TSH.
- •Kombined hyperlipidiemia TG > 4 mmol/L
- •Nefrotic syndrome: proteinuria > 3 g/L and s-albumin < 30 g/l
- •Cholestasis (alcalic fosfatase > 105 U/L and GGT > 55 U/L) 14 days prior to LDL-C measuring
- •Pharmacological induced hyperlipidimia
研究组 & 干预措施
Biochemistry interpretive comment on LDL-C levels
The general practitioners and hospital wards will be allocated in cluster according to their providing lab, and stepwise implement the comment on LDL-C ≥ 4 mmol/L in persons under the age of 40 and ≥ 5 mmol/L in persons ≥ 40 years. Raising awareness on familial hypercholesterolemia an encouraging to referral.
Cluster 1. Will from the 01.12.2022 implement comment on LDL-C Cluster 2. Will from the 01.03.2023 implement comment on LDL-C Cluster 3. Will from the 01.06.2023 implement comment on LDL-C Cluster 4.Will from the 01.09.2023 implement comment on LDL-C
干预措施: Biochemistry interpretive comment on elevated LDL-C levels (Other)
Control
The clusters will act as their own controls, due to the stepwise implementation of the comment.
Cluster 2: Will not implement the comment before the 01.03.2023 Cluster 3: Will not implement the comment before the 01.06.2023 Cluster 4: Will not implement the comment before the 01.09.2023
结局指标
主要结局
Number of patients reffered to lipid clinic
时间窗: 12-18 months
Proportion of referred patients to lipid clinics in the region of Southern Denmark after establishment of interpretive comment on LDL-C, compared to proportion before the comment.
Diagnosed patients with Familial Hyperchoelsterolemia
时间窗: During 9-12 months due to waiting time for genetic test
Proportion of patients diagnosed with familial hypercholesterolemia (Dutch clinical lipid score ≥ 6) in the Region of Southern Denmark after establishment of interpretive comment on LDL-C, compared to proportion before the comment.
次要结局
- Familial hypercholesterolemia mutations(9-12 months due to waiting time for genetic test)
- TSH(3 months)
- Hba1C(3 months)
- Triglycerides(3 months)
- HDL-Cholesterol(3 months)
- Change in LDL-C(3-6 months)
- Lipoprotein(a)(3 months)
研究者
Jakob Knold
MD
Odense University Hospital