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

NCT01678521 | Completed

• 1 other identifier: MZentiPTX3
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypercholesterolemia

Keywords

Hypercholesterolemia; LDL-apheresis; Coronary artery disease; PTX3; CRP; IL6; IL10

Outcome Measures

Primary Outcomes (1)

• acute change in PTX3 plasma values

  blood samples will be collected before and after a single LDL-apheresis treatment

  before and at the end of one LDL-apheresis treatment (about 6 hours)

Secondary Outcomes (2)

• acute change in hsCRP

  before and at the end of one LDL-apheresis treatment (about 6 hours)

• acute change in IL6 and IL10

  before and at the end of one LDL-apheresis treatment (about 6 hours)

Study Arms (1)

Hypercholesterolemic patients

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

Procedure: LDL-apheresis

Interventions

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.

Also known as: HELP-apheresis

Hypercholesterolemic patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hypercholesterolemic patients with documented CAD, on cronic fortnightly HELP-apheresis treatment.

You may qualify if:

• Hypercholesterolemia
• documented CAD
• chronic LDL-apheresis treatment

You may not qualify if:

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

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

Endocrinologia e Malattie Metaboliche, Azienda Ospedaliera Universitaria Integrata Verona

Verona, Piazzale Stefani1, 37126, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum and plasma

MeSH Terms

Conditions

Hypercholesterolemia; Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Enzo Bonora, Professor

  Universita di Verona

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: August 24, 2012
• First Posted: September 5, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 19, 2014

Record last verified: 2014-12

Locations

IT (1)