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

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01678521
• Other study ID #: MZentiPTX3
• Status: Completed
• Phase: N/A
• First received: August 24, 2012
• Last updated: December 18, 2014
• Start date: September 2012
• Est. completion date: December 2013

Study information

• Verified date: December 2014
• Source: Universita di Verona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Hypercholesterolemia

• documented CAD

• chronic LDL-apheresis treatment

Exclusion Criteria:

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Hypercholesterolemia
• Myocardial Ischemia

Intervention

Procedure:
• LDL-apheresis
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.

Locations

Country	Name	City	State
Italy	Endocrinologia e Malattie Metaboliche, Azienda Ospedaliera Universitaria Integrata Verona	Verona	piazzale Stefani1

Sponsors (1)

Lead Sponsor	Collaborator
Universita di Verona

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	acute change in hsCRP	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)	No
Secondary	acute change in IL6 and IL10	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)	No