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

Lymphedema Clinical Trial

— LiLY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05962827
• Other study ID #: 22-AOI-05
• Secondary ID: 2023-A00407-38
• Status: Recruiting
• Phase: N/A
• Start date: December 8, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: verena FASSBENDER
• Phone: 0492034702
• Email: fassbender.v[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Patients over 18 years of age.

• Patient with primary or secondary lymphedema confirmed at consultation or in day hospital.

• Signature of informed consent.

• Person affiliated to or benefiting from a social security scheme

Exclusion Criteria:

• Person refusing informed consent.

• Pregnant or breast-feeding women (urine pregnancy test performed in women of -childbearing age).

• Patients undergoing secondary cardiovascular prevention (MI, stroke, AOMI, etc.).

• Persons deprived of their liberty by judicial or administrative decision, persons under legal protection.

Related Conditions & MeSH terms

• Lymphedema

Intervention

Diagnostic Test:
• lipoprotein (a)
dosage of lipoprotein (a)

Locations

Country	Name	City	State
France	Centre Antoine Lacassagne	Nice
France	Chu de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the prevalence of hyperlipoproteinemia (a) in a population of patients with primary or secondary lymphedema	The primary endpoint will be lipoprotein (a) > 30 mg/dL, defining hyperlipoproteinemia (a).	day 0
Secondary	To study the modification of the SCORE-2 /SCORE-OP index of cardiovascular risk assessment at re-evaluation,	To study the modification of the SCORE-2 /SCORE-OP index	day 5
Secondary	To study the modification of the cardiovascular risk assessment calcium score at reassessment, taking into account the presence of hyperlipoproteinemia (a).	cardiovascular risk assessment calcium score at reassessment,	day 5