HypercholesterolemiaNCT01678521
Effect of LDL-apheresis on PTX3 Plasma Levels in Hypercholesterolemic Patients
An observational study of Hypercholesterolemia, run by Universita di Verona at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- LDL-apheresis
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2012to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hypercholesterolemic patients with documented CAD, on cronic fortnightly HELP-apheresis treatment.
Who may be able to join
- Hypercholesterolemia
- documented CAD
- chronic LDL-apheresis treatment
Who cannot join
- mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
Trial locations and contacts
1 site in 1 country.
Italy1 site
Endocrinologia e Malattie Metaboliche, Azienda Ospedaliera Universitaria Integrata Verona
Verona, Piazzale Stefani1, 37126
About this study
Official title: Effect of LDL-apheresis on Pentraxin3 Plasma Levels in Hypercholesterolemic Patients With Coronary Artery Disease
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.
Read the 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.
- Conditions
- Hypercholesterolemia
- Being tested
- LDL-apheresis
- Keywords
- Hypercholesterolemia, LDL-apheresis, Coronary artery disease, PTX3, CRP, IL6, IL10
- Medical subject headings
- Hypercholesterolemia, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LDL-apheresisProcedure or surgery
Also called HELP-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 group | Role | What they receive |
|---|---|---|
| Hypercholesterolemic patients | Hypercholesterolemic Patients with documented CAD and poor- or non responders or intolerant to pharmacological treatment (statins) on chronic LDL-apheresis treatment Receives: Procedure: LDL-apheresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
acute change in PTX3 plasma values
blood samples will be collected before and after a single LDL-apheresis treatment
Measured: before and at the end of one LDL-apheresis treatment (about 6 hours)
Secondary outcomes (2)
acute change in hsCRP
blood samples will be collected before and after a single LDL-apheresis treatment
Measured: before and at the end of one LDL-apheresis treatment (about 6 hours)
acute change in IL6 and IL10
blood samples will be collected before and after a single LDL-apheresis treatment
Measured: before and at the end of one LDL-apheresis treatment (about 6 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Grazia Zenti, Universita di Verona
- Investigators
- Enzo Bonora, Professor, Study director, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01678521
- Sponsor's protocol ID
- MZentiPTX3
- Status last verified
- Dec 2014
- First submitted
- 24 Aug 2012
- Last updated
- 19 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of LDL-apheresis on Pentraxin3 Plasma Levels in Hypercholesterolemic Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT01678521
- Acronym / sponsor ID
- MZentiPTX3
- Conditions
- Hypercholesterolemia
- Keywords
- Hypercholesterolemia, LDL-apheresis, Coronary artery disease, PTX3, CRP, IL6, IL10
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 5 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypercholesterolemic patients | – | Procedure: LDL-apheresisHypercholesterolemic Patients with documented CAD and poor- or non responders or intolerant to pharmacological treatment (statins) on chronic LDL-apheresis treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hypercholesterolemic patients with documented CAD, on cronic fortnightly HELP-apheresis treatment.
Key inclusion criteria (3 listed)
- Hypercholesterolemia
- documented CAD
- chronic LDL-apheresis treatment
Key exclusion criteria (1 listed)
- mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LDL-apheresisAlso: HELP-apheresisThe 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. | Procedure or surgery | Hypercholesterolemic patients |
Primary outcome
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
2 secondary outcomes
acute change in hsCRP
Time frame: before and at the end of one LDL-apheresis treatment (about 6 hours)
acute change in IL6 and IL10
Time frame: before and at the end of one LDL-apheresis treatment (about 6 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enzo Bonora, Professor study director
Universita di Verona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercholesterolemia, run by Universita di Verona at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acute change in PTX3 plasma values (time frame: before and at the end of one LDL-apheresis treatment (about 6 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2014.