Effect of LDL-apheresis on PTX3 Plasma Levels in Hypercholesterolemic Patients
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|