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临床试验/NCT07141628
NCT07141628尚未招募不适用

Etude de l'hyperlipoprotéinémie A Comme Marqueur de Risque Cardio-vasculaire Chez Les Patients Atteints de Maladie rénale Chronique au Stade 4

Centre Hospitalier Universitaire de Nīmes1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
300
试验地点
1
主要终点
Link between hyperlipoproteinemia A and a first event of cardiovascular death

研究概览

简要总结

The blood level of lipoprotein A (Lp(a)) is linked to mutations in gene 6 and is associated with atherothrombotic risk and clinical manifestations such as myocardial infarction, ischemic stroke, and aortic valve calcification and stenosis. Several studies show an increased cardiovascular risk for a level >125 nmol/L. Patients with severe chronic kidney disease (CKD) or on hemodialysis are at high cardiovascular risk, and Lp(a) levels would allow for better reclassification of this cardiovascular risk in the general population.

The study authors wished to the heterogeneity of the Lp(a) level in the population with CKD stages 4 without renal replacement therapy and to identify whether a high Lp(a) level is associated with cardiovascular comorbidity defined by the presence of cardiovascular comorbidity after adjustment for known risk factors such as diabetic status, obesity, smoking, LDLc level and medical treatment for cardiovascular prevention (statins, etc.). Furthermore, they will evaluate whether there is a link between a high level (> 125 mmol/l) of Lp(a) at inclusion in the cohort and the occurrence of cardiovascular or renal events (i.e. death of cardiovascular origin or occurrence of MI, stroke, stage 4 peripheral artery disease (PAD) or initiation of renal replacement) over a follow-up period of 18 months which could raise questions about the benefit of a specific treatment which remains to be evaluated.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The patient must have given their free and informed consent and signed the consent form
  • The patient must be a member or beneficiary of a health insurance plan
  • Patient being followed at the Nîmes University Hospital for stage 4 chronic kidney disease without replacement therapy
  • Patient available for follow-up at 18 months

排除标准

  • The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
  • The subject refuses to sign the consent
  • It is impossible to give the subject informed information
  • The patient is under safeguard of justice or state guardianship
  • Familial hypercholesterolemia
  • Morbid obesity (BMI > 40 kg/m2).
  • Persons deprived of their liberty by a judicial or administrative decision, persons receiving psychiatric care, and persons admitted to a health or social care facility for purposes other than research (Article L1121-6 of the French Public Health Code)

结局指标

主要结局

Link between hyperlipoproteinemia A and a first event of cardiovascular death

时间窗: 18 months

cardiovascular death: yes/no

Link between hyperlipoproteinemia A and a first event of myocardial infarction

时间窗: 18 months

myocardial infarction: yes/no

Link between hyperlipoproteinemia A and a first event of stroke

时间窗: 18 months

stroke: yes/no

Link between hyperlipoproteinemia A and a first event of peripheral artery disease stage 4

时间窗: 18 months

peripheral artery disease stage 4: yes/no

Link between hyperlipoproteinemia A and a first event of initiation of renal replacement therapy

时间窗: 18 months

initiation of renal replacement therapy: yes/no

次要结局

  • Rate of hyperlipoproteinemia A(Baseline (Day 0))
  • Link between hyperlipoproteinemia A and a history of ischemic heart disease at inclusion(Baseline (Day 0))
  • Link between hyperlipoproteinemia A and a history ischemic stroke at inclusion(Baseline (Day 0))
  • Link between hyperlipoproteinemia A and a history of calcified aortic stenosis at includion(Baseline (Day 0))
  • Link between hyperlipoproteinemia A and a history of lower limb arterial disease stage 2-4 at inclusion(Baseline (Day 0))
  • Link between hyperlipoproteinemia A and a history of vascular nephropathy at inclusion(Baseline (Day 0))
  • Link between hyperlipoproteinemia A and a history of arterial angioplasty at any site at inclusion(Month 18)
  • Link between hyperlipoproteinemia A and hospitalization for cardiac decompensation during follow-up(Month 18)
  • Link between hyperlipoproteinemia A and the occurrence of repeated cardiovascular events during follow-up(Month 18)

研究者

发起方
Centre Hospitalier Universitaire de Nīmes
申办方类型
Other
责任方
Sponsor

研究点 (1)

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