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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01678521

Enrollment

Registered

2012-09-05

Start date

2012-09-30

Completion date

2013-12-31

Last updated

2014-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

Keywords

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

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.

Interventions

PROCEDURELDL-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.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Hypercholesterolemia * documented CAD * chronic LDL-apheresis treatment

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026