Evaluation of Digiphysical Screening for Familial Hypercholesterolemia - Efficacy of Digiphysical Screening, Effects on Cardiovascular Morbidity and Mortality and Health Economic Aspects
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 30,000
- 试验地点
- 1
- 主要终点
- Impact of mutation positive Familial Hypercholesterolemia on cardiovascular disease burden
研究概览
简要总结
Longitudinal and observational registry-based cohort study of individuals participating in the national digiphysical screening program for Familial Hypercholesterolemia. The information collected in the screening process will be combined in pseudo-anonymous form with data from the National Board of Health and Welfare (registries: Cause of Death, Diagnoses according to International Classification of Diseases (ICD) and Prescribed drugs) and Statistic Sweden (Longitudinal integrated database for health insurance and labour market studies). Primary analysis: association between Familial Hypercholesterolemia and cardiovascular disease. Secondary analysis: efficacy and health economic aspects of digiphysical screening for Familial Hypercholesterolemia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Swedish personal identification number
排除标准
- •Decline informed consent
结局指标
主要结局
Impact of mutation positive Familial Hypercholesterolemia on cardiovascular disease burden
时间窗: Through study completion, until 2041.
Comparison of cardiovascular disease burden (presence of ischemic heart disease, ischemic cerebrovascular disease and/or peripheral artery disease) in relation to age in patients with mutation positive versus negative Familial Hypercholesterolemia. Data is reported after 2, 5, 10, 15 and 20 years.
Comparison of cardiovascular disease burden between patients with diagnosed Familial Hypercholesterolemia and individuals aquitted from the diagnose
时间窗: Through study completion, until 2041.
Comparison of cardiovascular disease burden (presence of ischemic heart disease, ischemic cerebrovascular disease and/or peripheral artery disease) in relation to age between patients diagnosed with Familial Hypercholesterolemia and individuals screened but acquitted of the diagnose. Data is reported after 2, 5, 10, 15 and 20 years.
Cardiovascular disease burden in patients with newly diagnosed Familial Hypercholesterolemia
时间窗: Through study completion, until 2041.
Presence of ischemic heart disease, ischemic cerebrovascular disease and/or peripheral artery disease in relation to age in patients with newly diagnosed Familial Hypercholesterolemia. Data is reported after 2, 5, 10, 15 and 20 years.
Change in cardiovascular disease burden in patients with diagnosed Familial Hypercholesterolemia
时间窗: Through study completion, until 2041.
Change in presence of ischemic heart disease, ischemic cerebrovascular disease and/or peripheral artery disease in relation to age in patients diagnosed Familial Hypercholesterolemia. Comparison is done between baseline and after 2, 5, 10, 15 and 20 years.
次要结局
- Health economic aspects of the digiphysical screening method to diagnose Familial Hypercholesterolemia(Through study completion, until 2041.)
- Key efficacy numbers and ratios of screened and diagnosed for the digiphysical screening method to diagnose Familial Hypercholesterolemia(Through study completion, until 2041.)
研究者
Jonas Brinck
Principal Investigator
Karolinska Institutet