search
Back to results

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

Primary Purpose

Lymphedema

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
lipoprotein (a)
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lymphedema

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CAUSERET Marion

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Determine the prevalence of hyperlipoproteinemia (a) in a population of patients with lymphedema

Arm Description

The primary endpoint will be lipoprotein (a) > 30 mg/dL, defining hyperlipoproteinemia (a).

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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
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,

Full Information

First Posted
July 19, 2023
Last Updated
September 26, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
search

1. Study Identification

Unique Protocol Identification Number
NCT05962827
Brief Title
Testing for Increased Lipoproteins (a) [LP(a)] in Lymphedema Patients: Li-LY
Acronym
LiLY
Official Title
Testing for Increased Lipoproteins (a) [LP(a)] in Lymphedema Patients: Li-LY
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Determine the prevalence of hyperlipoproteinemia (a) in a population of patients with lymphedema
Arm Type
Experimental
Arm Description
The primary endpoint will be lipoprotein (a) > 30 mg/dL, defining hyperlipoproteinemia (a).
Intervention Type
Diagnostic Test
Intervention Name(s)
lipoprotein (a)
Intervention Description
dosage of lipoprotein (a)
Primary Outcome Measure Information:
Title
Determine the prevalence of hyperlipoproteinemia (a) in a population of patients with primary or secondary lymphedema
Description
The primary endpoint will be lipoprotein (a) > 30 mg/dL, defining hyperlipoproteinemia (a).
Time Frame
day 0
Secondary Outcome Measure Information:
Title
To study the modification of the SCORE-2 /SCORE-OP index of cardiovascular risk assessment at re-evaluation,
Description
To study the modification of the SCORE-2 /SCORE-OP index
Time Frame
day 5
Title
To study the modification of the cardiovascular risk assessment calcium score at reassessment, taking into account the presence of hyperlipoproteinemia (a).
Description
cardiovascular risk assessment calcium score at reassessment,
Time Frame
day 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MARION F CAUSERET
Phone
0492034702
Email
causeret.m@chu-nice.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Verena FASSBENDER
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
CAUSERET Marion
City
Nice
State/Province
Centre Antoine Lacassagne
ZIP/Postal Code
06003
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marion CAUSERET
Phone
0492034702
Email
causeret.m@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
élise GILBERT

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs