Effect of LDL-apheresis on PTX3 Plasma Levels in Hypercholesterolemic Patients
Recruitment status was Recruiting
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Effect of LDL-apheresis on Pentraxin3 Plasma Levels in Hypercholesterolemic Patients With Coronary Artery Disease|
- acute change in PTX3 plasma values [ Time Frame: before and at the end of one LDL-apheresis treatment (about 6 hours) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]blood samples will be collected before and after a single LDL-apheresis treatment
Biospecimen Retention: Samples Without DNA
serum and plasma
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01678521
|Contact: Maria Grazia Zenti, MDfirstname.lastname@example.org|
|Contact: Riccardo C Bonadonna, MD, PHDemail@example.com|
|Endocrinologia e Malattie Metaboliche, Azienda Ospedaliera Universitaria Integrata Verona||Recruiting|
|Verona, piazzale Stefani1, Italy, 37126|
|Contact: Maria Grazia Zenti, MD +390458123110 firstname.lastname@example.org|
|Contact: Riccardo C Bonadonna, MD,PHD +390458123115 email@example.com|
|Principal Investigator: Maria Grazia Zenti, MD|
|Study Director:||Enzo Bonora, Professor||Universita di Verona|