Effect of LDL-apheresis on PTX3 Plasma Levels in Hypercholesterolemic Patients

Study Overview
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Brief Summary
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Inflammation plays a major role in atherosclerosis. Pentraxin 3 (PTX3) a multifunctional pattern-recognition protein, is expressed in many tissues/cells, including innate immunity cells, endothelium and atherosclerotic plaques. Its role is controversial: it may exert protective cardiovascular effects and/or it may be an indicator of plaque vulnerability and future cardiovascular risk. LDL-Apheresis removes apoB100-containing lipoproteins and it can prevent progression of coronary artery disease (CAD). LDL-Apheresis exerts non-lipidic beneficial effects on the procoagulatory state and on hemorheology. No data exist about the effects of LDL-Apheresis on plasma PTX3 levels.

Detailed Description
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Hypercholesterolemic patients with documented CAD, on chronic fortnightly LDL-apheresis treatment will be enrolled in this study. Blood samples will be collected before and after a single LDL-Apheresis treatment to asses PTX3, HsCRP, IL6, IL10, Fibrinogen and lipid plasma levels.

Official Title
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Effect of LDL-apheresis on Pentraxin3 Plasma Levels in Hypercholesterolemic Patients With Coronary Artery Disease

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Procedure: LDL-apheresis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hypercholesterolemia documented CAD chronic LDL-apheresis treatment Exclusion Criteria: mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hypercholesterolemic patients<br>Hypercholesterolemic Patients with documented CAD and poor- or non responders or intolerant to pharmacological treatment (statins) on chronic LDL-apheresis treatment | Procedure: LDL-apheresis<br>* The acronym H.E.L.P. stands for Heparin-induced Extracorporeal Low-density-lipoprotein Precipitation. Antecubital veins served as blood access. The mean blood volume processed per session is of approximately 3000 ml.<br>* Other names: HELP-apheresis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute change in PTX3 plasma values | blood samples will be collected before and after a single LDL-apheresis treatment | before and at the end of one LDL-apheresis treatment (about 6 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute change in hsCRP | blood samples will be collected before and after a single LDL-apheresis treatment | before and at the end of one LDL-apheresis treatment (about 6 hours) | 
| acute change in IL6 and IL10 | blood samples will be collected before and after a single LDL-apheresis treatment | before and at the end of one LDL-apheresis treatment (about 6 hours) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CRP, IL6, Hypercholesterolemia, LDL-apheresis, Coronary artery disease, PTX3, IL10