Effect of LDL-apheresis on PTX3 Plasma Levels in Hypercholesterolemic Patients
|ClinicalTrials.gov Identifier: NCT01678521|
Recruitment Status : Completed
First Posted : September 5, 2012
Last Update Posted : December 19, 2014
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.
|Condition or disease||Intervention/treatment|
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.
|Study Type :||Observational|
|Actual Enrollment :||12 participants|
|Official Title:||Effect of LDL-apheresis on Pentraxin3 Plasma Levels in Hypercholesterolemic Patients With Coronary Artery Disease|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
Hypercholesterolemic Patients with documented CAD and poor- or non responders or intolerant to pharmacological treatment (statins) on chronic LDL-apheresis treatment
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.
Other Name: HELP-apheresis
- acute change in PTX3 plasma values [ Time Frame: before and at the end of one LDL-apheresis treatment (about 6 hours) ]blood samples will be collected before and after a single LDL-apheresis treatment
- acute change in hsCRP [ Time Frame: before and at the end of one LDL-apheresis treatment (about 6 hours) ]blood samples will be collected before and after a single LDL-apheresis treatment
- acute change in IL6 and IL10 [ Time Frame: before and at the end of one LDL-apheresis treatment (about 6 hours) ]blood samples will be collected before and after a single LDL-apheresis treatment
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01678521
|Endocrinologia e Malattie Metaboliche, Azienda Ospedaliera Universitaria Integrata Verona|
|Verona, piazzale Stefani1, Italy, 37126|
|Study Director:||Enzo Bonora, Professor||Universita di Verona|