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

Completed

• Conditions: Hypercholesterolemia
• Interventions: Procedure: LDL-apheresis

• Registration Number: NCT01678521
• Lead Sponsor: Universita di Verona

Brief Summary

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

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 Timeline

• Study First Submitted: 2012-08-24
• Study Start: 2012-09
• Study First Submitted QC: 2012-09-04
• Study First Posted: 2012-09-05
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-18
• Last Update Posted: 2014-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Hypercholesterolemia
• documented CAD
• chronic LDL-apheresis treatment

Exclusion Criteria

• mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hypercholesterolemic patients	LDL-apheresis	Hypercholesterolemic Patients with documented CAD and poor- or non responders or intolerant to pharmacological treatment (statins) on chronic LDL-apheresis treatment

Primary Outcome Measures

Name	Time	Method
acute change in PTX3 plasma values	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

Secondary Outcome Measures

Name	Time	Method
acute change in hsCRP	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	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

Trial Locations

Locations (1)

Endocrinologia e Malattie Metaboliche, Azienda Ospedaliera Universitaria Integrata Verona; 🇮🇹 Verona, piazzale Stefani1, Italy