Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05962827
Status:
RECRUITING
Last Update Posted:
2024-01-12
First Post:
2023-07-19
Brief Title:
Testing for Increased Lipoproteins a LPa in Lymphedema Patients Li-LY
Sponsor:
Centre Hospitalier Universitaire de Nice
Organization:
Centre Hospitalier Universitaire de Nice
Study Overview
Official Title:
Testing for Increased Lipoproteins a LPa in Lymphedema Patients Li-LY
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LiLY
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 lipoproteina LPa 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 LPa 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 Lpa Our team observed an elevated Lpa level 30 mgdL 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 Lpa 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 Lpa 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 SCORE2SCORE2-OP and the coronary calcium score We will look for factors influencing plasma LPa levels both general factors suspected of playing a role and factors specific to lymphedema
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 Lpa Our team observed an elevated Lpa level 30 mgdL 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 Lpa 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 Lpa 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 SCORE2SCORE2-OP and the coronary calcium score We will look for factors influencing plasma LPa 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 lipoproteina LPa 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 LPa 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 Lpa Our team observed an elevated Lpa level 30 mgdL 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 Lpa 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 Lpa 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 SCORE2SCORE2-OP and the coronary calcium score We will look for factors influencing plasma LPa levels both general factors suspected of playing a role and factors specific to lymphedema
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 Lpa Our team observed an elevated Lpa level 30 mgdL 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 Lpa 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 Lpa 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 SCORE2SCORE2-OP and the coronary calcium score We will look for factors influencing plasma LPa levels both general factors suspected of playing a role and factors specific to lymphedema
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-A00407-38 | OTHER | CHU de Nice | None |