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

NCT ID: NCT01678521

Last Updated: 2014-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-12-31

Brief Summary

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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

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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.

Conditions

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Hypercholesterolemia

Keywords

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Hypercholesterolemia LDL-apheresis Coronary artery disease PTX3 CRP IL6 IL10

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Hypercholesterolemic patients

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

LDL-apheresis

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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HELP-apheresis

Eligibility Criteria

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Inclusion Criteria

* Hypercholesterolemia
* documented CAD
* chronic LDL-apheresis treatment

Exclusion Criteria

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

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universita di Verona

OTHER

Sponsor Role lead

Responsible Party

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Maria Grazia Zenti

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Enzo Bonora, Professor

Role: STUDY_DIRECTOR

Universita di Verona

Locations

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Endocrinologia e Malattie Metaboliche, Azienda Ospedaliera Universitaria Integrata Verona

Verona, Piazzale Stefani1, Italy

Site Status

Countries

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Italy

Other Identifiers

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MZentiPTX3

Identifier Type: -

Identifier Source: org_study_id