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

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.

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Key information

Conditions

Hypercholesterolemia Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Dyslipidemias Heart Diseases Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Endocrinologia e Malattie Metaboliche, Azienda Ospedaliera Universitaria Integrata Verona

Verona, Piazzale Stefani1, 37126, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Hypercholesterolemia
documented CAD
chronic LDL-apheresis treatment

Exclusion criteria

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

Treatment and study plan

LDL-apheresis

Procedure

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 names: HELP-apheresis

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Universita di Verona

Other

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Sep 5, 2012
Registry last updated: Dec 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed