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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with stage 4 chronic kidney disease without replacement therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lipoprotein A level dosing | Diagnostic Test | Plasma levels measured in mmol/l |
|
| Measure | Description | Time Frame |
|---|---|---|
| Link between hyperlipoproteinemia A and a first event of cardiovascular death | cardiovascular death: yes/no | 18 months |
| Link between hyperlipoproteinemia A and a first event of myocardial infarction | myocardial infarction: yes/no | 18 months |
| Link between hyperlipoproteinemia A and a first event of stroke | stroke: yes/no | 18 months |
| Link between hyperlipoproteinemia A and a first event of peripheral artery disease stage 4 | peripheral artery disease stage 4: yes/no | 18 months |
| Link between hyperlipoproteinemia A and a first event of initiation of renal replacement therapy | initiation of renal replacement therapy: yes/no | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of hyperlipoproteinemia A | defined as a lipoprotein A level > 125 nmol/L | Baseline (Day 0) |
| Link between hyperlipoproteinemia A and a history of ischemic heart disease at inclusion | Ischemic heart disease: yes/no |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with stage 4 chronic kidney disease without replacement therapy followed as outpatients at Nîmes University Hospital.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olivier Moranne | Contact | 04.66.68.32.59 | olivier.moranne@chu-nimes.fr |
| Name | Affiliation | Role |
|---|---|---|
| Olivier Moranne | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | 30029 | France |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| Baseline (Day 0) |
| Link between hyperlipoproteinemia A and a history ischemic stroke at inclusion | Ischemic stroke: yes/no | Baseline (Day 0) |
| Link between hyperlipoproteinemia A and a history of calcified aortic stenosis at includion | Calcified aortic stenosis: yes/no | Baseline (Day 0) |
| Link between hyperlipoproteinemia A and a history of lower limb arterial disease stage 2-4 at inclusion | Lower limb arterial disease stage 2-4: yes/no | Baseline (Day 0) |
| Link between hyperlipoproteinemia A and a history of vascular nephropathy at inclusion | Vascular nephropathy: yes/no | Baseline (Day 0) |
| Link between hyperlipoproteinemia A and a history of arterial angioplasty at any site at inclusion | coronary artery or limb angioplasty: yes/no | Month 18 |
| Link between hyperlipoproteinemia A and hospitalization for cardiac decompensation during follow-up | hospitalization for cardiac decompensation: yes/no | Month 18 |
| Link between hyperlipoproteinemia A and the occurrence of repeated cardiovascular events during follow-up | Cumulative events from the following: myocardial infarction, stroke, PAD stage 4, initiation of renal replacement therapy, death, arterial angioplasty at any site, cardiac decompensation | Month 18 |