CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029, France
NCT Number: NCT07141628
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.
Trial opening soon.
Get Notified18 year–80 year
All sexes
Observational
Nîmes, 30029, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Plasma levels measured in mmol/l
Time frame: 18 months
cardiovascular death: yes/no
Time frame: 18 months
myocardial infarction: yes/no
Time frame: 18 months
stroke: yes/no
Time frame: 18 months
peripheral artery disease stage 4: yes/no
Time frame: 18 months
initiation of renal replacement therapy: yes/no
Time frame: Baseline (Day 0)
defined as a lipoprotein A level > 125 nmol/L
Time frame: Baseline (Day 0)
Ischemic heart disease: yes/no
Time frame: Baseline (Day 0)
Ischemic stroke: yes/no
Time frame: Baseline (Day 0)
Calcified aortic stenosis: yes/no
Time frame: Baseline (Day 0)
Lower limb arterial disease stage 2-4: yes/no
Time frame: Baseline (Day 0)
Vascular nephropathy: yes/no
Time frame: Month 18
coronary artery or limb angioplasty: yes/no
Time frame: Month 18
hospitalization for cardiac decompensation: yes/no
Time frame: Month 18
Cumulative events from the following: myocardial infarction, stroke, PAD stage 4, initiation of renal replacement therapy, death, arterial angioplasty at any site, cardiac decompensation
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Universitaire de Nīmes
Other
Etude de l'hyperlipoprotéinémie A Comme Marqueur de Risque Cardio-vasculaire Chez Les Patients Atteints de Maladie rénale Chronique au Stade 4
Acronym: LPACKD45
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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