Testing for Increased Lipoproteins (a) [LP(a)] in Lymphedema Patients: Li-LY

Sponsor
Centre Hospitalier Universitaire de Nice
Study ID
NCT05962827
Status
Recruiting
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Conditions

  • Lymphedema

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • lipoprotein (a) — DIAGNOSTIC_TEST
    dosage of lipoprotein (a)

Study Details

Lymphedema is a chronic disease that causes lymph to accumulate in the interstitial tissue. The lymphatic network is involved in the metabolism of lipids and lipoproteins, and this accumulation leads to lipid deposits in the tissues involved. The level of lipoprotein(a) \[LP(a)\] has been shown to be a cardiovascular risk factor, which is partly genetically determined and influenced by certain factors (chronic renal failure, statin treatment, sporting activity or a diet low in saturated fatty acids...). Plasma levels of LP(a) lipoproteins (a) are linearly associated with an increased risk of myocardial infarction and carotid and femoral vascular stenosis. We currently manage patients with primary or secondary lymphedema, whatever the etiology, in the vascular medicine and explorations unit at Nice University Hospital. Those taking part in intensive inpatient decongestive therapy benefit from a blood test, in particular for lipids \[total cholesterol, triglycerides, HDL and LDL cholesterol, apolipoproteins A and B and Lp(a)\]. Our team observed an elevated Lp(a) level \>30 mg/dL in 10 of the 17 patients in whom we carried out this test (whether or not dyslipidemia existed, and whether or not it was known or treated). This is a very high prevalence compared with the general population, in whom an increased level is found in 25% of patients. In view of the impact of Lp(a) on cardiovascular risk and the involvement of the lymphatic system in lipoprotein metabolism, it seems essential to verify our preliminary results on a larger population. In this multicenter cross-sectional trial, we propose to perform Lp(a) lipoprotein assays in lymphedema patients to determine whether there is an increase in this marker in this pathological context. We will also study the concordance of this level with cardiovascular risk assessment scores such as SCORE2/SCORE2-OP and the coronary calcium score. We will look for factors influencing plasma LP(a) levels, both general factors suspected of playing a role and factors specific to lymphedema.

Key Dates

First listed
Jul 27, 2023
Start date
Dec 8, 2023
Status verified
Nov 2025
Primary completion
Aug 11, 2026
Completion
Aug 11, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Determine the prevalence of hyperlipoproteinemia (a) in a population of patients with lymphedema
    The primary endpoint will be lipoprotein (a) \> 30 mg/dL, defining hyperlipoproteinemia (a).

Primary Outcome Measure

Determine the prevalence of hyperlipoproteinemia (a) in a population of patients with primary or secondary lymphedema [ Time Frame: day 0 ]

Central Contacts

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