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临床试验/NCT06157983
NCT06157983进行中(未招募)不适用

Evaluation of Cascade Screening for Elevated Lipoprotein(a) in Relatives to Patients With Atherosclerotic Coronary Artery Disease

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 1,950 人开始时间: 2023年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
1,950
试验地点
1
主要终点
Difference in proportion of elevated plasma lipoprotein(a) between index and first degree relatives

研究概览

简要总结

The aim of the current project is to evaluate the penetrance of elevated plasma Lp(a) levels in patients with atherosclerotic coronary artery disease to their first- and second-degree biological relatives based on data from a clinical health care development project.

详细描述

An elevated plasma level of lipoprotein(a) [Lp(a)] is an independent and causative risk factor for atherosclerotic cardiovascular disease. The Lp(a) plasma level is predominantly genetically determined via a complex hereditary pattern of the LPA gene, and remains relatively constant throughout an individual's entire life cycle. The relationship between plasma Lp(a) and the risk for a cardiovascular event has been shown to be linear.

Cascade screening, i.e. screening of biological relatives of the first detected patient (index) with a disease in a family, is an effective approach to identify and diagnose new patients with hereditary diseases. The method has been shown to be cost-effective for the most common genetically caused dyslipidemia, familial hypercholesterolemia, but the knowledge if cascade screening would be an effective method to screen for elevated plasma Lp(a) is not known.

The aim of the current project is to evaluate the penetrance of elevated plasma Lp(a) levels in patients with atherosclerotic coronary artery disease to their first- and second-degree biological relatives. The study will be based on results from a clinical health care development project in which patients who have had their plasma Lp(a) measured in the clinical routine will be asked to participate in the project. The participating patients invite their relatives to participate in the cascade screening and to measure their plasma Lp(a) levels. Six Swedish hospitals participate in the project and 750 patients with atherosclerotic coronary artery disease be included and divided into three strata according to their plasma Lp(a) level (low <70 nmol/L; intermediate 70-169 nmol/L; high >170 nmol/L). The indexes will in turn invite 1200 first- and second-degree relatives to have their plasma Lp(a) measured.

A scientific evaluation of the health care development project will be performed to study the penetrance of elevated plasma Lp(a) levels in indexes to their relatives.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • diagnosis of familial hypercholesterolemia
  • chronic kidney disease stadium ≥4

结局指标

主要结局

Difference in proportion of elevated plasma lipoprotein(a) between index and first degree relatives

时间窗: Dataset will be analysed after completion of health care development project (anticipated March 2025)

Difference in proportion of low, intermediate and high plasma lipoprotein(a) levels between first degree relatives stratified on index patients Lp(a) level (i.e low, intermediate, high)

Difference in proportion of elevated plasma lipoprotein(a) between index and second degree relatives

时间窗: Dataset will be analysed after completion of health care development project (anticipated March 2025)

Difference in proportion of low, intermediate and high plasma lipoprotein(a) levels between second degree relatives stratified on index patients Lp(a) level (i.e low, intermediate, high)

次要结局

  • Difference in cardiovascular risk factors between index and relatives(Dataset will be analysed after completion of health care development project (anticipated March 2025))
  • Difference in cardiovascular disease burden between index and relatives(Dataset will be analysed after completion of health care development project (anticipated March 2025))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jonas Brinck

Associate Professor

Karolinska Institutet

研究点 (1)

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