A Pilot Study Investigating the Effects of Lipid-therapy Intensification With Alirocumab on Endothelial Function, Carotid Arteries, Lipoprotein Particle Subfractions, Inflammation and Post-prandial Lipemia in Clinical Routine
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Atherosclerosis
- Sponsor
- Medical University of Graz
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Change of mean carotid vessel wall fractional anisotropy (2-Dimensional Cardiovascular Magnet Resonance) by very potent lipid-therapy intensification with Alirocumab
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
A prospective, open-label, pilot study with 24 cardiovascular high risk patients (N=24) having insufficient Low density lipoprotein cholesterin (LDL-C) reduction despite standard of care lipid-modifying therapies (LMTs), to evaluate the effects of potent lipid-therapy intensification via the recently approved monoclonal, human anti-PCSK9 antibody Alirocumab on endothelial function, inflammation, lipoprotein particle subfractions, carotid arteries and post-prandial lipemia in clinical routine at the Medical University of Graz.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient scheduled for treatment with Alirocumab in clinical routine (after approval of cost coverage by insurance company)
- •No previous treatment with PCSK9 antibodies
- •Signed informed consent form
Exclusion Criteria
- •Age of \< 18 years
- •Pregnancy (pregnancy test at screening visit)
- •Breast-feeding
- •Impossibility to perform magnetic resonance imaging of the carotid artery (claustrophobia, carotid stent)
Outcomes
Primary Outcomes
Change of mean carotid vessel wall fractional anisotropy (2-Dimensional Cardiovascular Magnet Resonance) by very potent lipid-therapy intensification with Alirocumab
Time Frame: From baseline to 10 weeks of treatment
Study participants will undergo a cardiovascular magnetic resonance imaging of the carotid vessels. High resolution diffusion tensor imaging (DTI) will be performed on one selected axial slice using read-out segmented EPI (rs-EPI) sequence on a 3T MR scanner.
Secondary Outcomes
- Change of FDD (flow-dependent dilation) in response to Alirocumab(From baseline to 10 weeks of treatment)
- Change of intima media thickness in response to Alirocumab(From baseline to 10 weeks of treatment)
- Change of post-prandial lipaemia in response to Alirocumab(From baseline to 10 weeks of treatment)
- Change of the lipoprotein subfractions in response to Alirocumab(From baseline to 10 weeks of treatment)
- Changes of inflammatory parameters in response to Alirocumab(From baseline to 10 weeks of treatment)