Investigating the Effects of Lipid-therapy Intensification With Alirocumab on Endothelial Function, Carotid Arteries, Lipoprotein Particle Subfractions, Inflammation and Post-prandial Lipemia (ALIROCKS)
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|ClinicalTrials.gov Identifier: NCT03559309|
Recruitment Status : Recruiting
First Posted : June 18, 2018
Last Update Posted : August 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Atherosclerosis Hypercholesterolemia Post Prandial Lipemia Cardiovascular Diseases||Diagnostic Test: Magnet Resonance Tomography, Carotid Arteries Sonography, Flow-mediated Dilation, Fat-tolerance Test, Laboratory Testing||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||June 20, 2018|
|Estimated Primary Completion Date :||December 1, 2019|
|Estimated Study Completion Date :||January 1, 2020|
Medical Treatment (Clinical Routine)
Diagnostic Test: Magnet Resonance Tomography, Carotid Arteries Sonography, Flow-mediated Dilation, Fat-tolerance Test, Laboratory Testing
Patients treated with Alirocumab in the clinical routine will have additional diagnostic tests as stated above. The clinical trial will be conducted as an open label, single arm study. The diagnostic tests will be done at baseline (BL) and after 10 weeks of treatment (W10) with Alirocumab.
- 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.
- Change of FDD (flow-dependent dilation) in response to Alirocumab [ Time Frame: From baseline to 10 weeks of treatment ]Vasodilation of the brachial artery will be measured with a linear array transducer, 8-13 MHz. Flow mediated dilatation is defined as the change in post-ischemic diameter as a percentage of the baseline diameter. Flow-independent vasodilatation will be evaluated by nitroglycerin-mediated dilatation. At least 15 minutes after the flow mediated procedure the brachial arterial diameter will be measured before and 3 minutes after sublingual administration of nitroglycerin (NTG 0.3 mg spray).
- Change of intima media thickness in response to Alirocumab [ Time Frame: From baseline to 10 weeks of treatment ]All ultrasound investigations will be performed at the Division of Angiology, Department of Internal Medicine, Medical University of Graz. Carotid intima-media thickness is defined as the mean of at least three different measurements of intima media thickness in a one-centimeter-long segment of the brachial common carotid artery.
- Change of post-prandial lipaemia in response to Alirocumab [ Time Frame: From baseline to 10 weeks of treatment ]Post-prandial lipaemia will be assessed with a fat-tolerance test (FTT). The participants will receive a standard fat rich meal. The Lipotest® meal is a diagnostic meal with special medical purpose, characterized as "Food for specialized diagnostic determination of postprandial triglycerides" and consists of 832 kCal total energy input (75 g saturated fat, 25 g carbohydrates, 10 g protein, 2,1 g fiber and 0,15 g salt).
- Change of the lipoprotein subfractions in response to Alirocumab [ Time Frame: From baseline to 10 weeks of treatment ]LDL-Cholesterol will not only be calculated via Friedewald formula, but all plasma lipoprotein particles will be subfractionated by ultracentrifugation / precipitation (Chylomicrons, VLDL, LDL and HDL). Plasma lipid levels will be measured enzymatically using an autoanalyzer. Particle concentrations of lipoprotein subclasses will be measured using nuclear magnetic resonance as previously described (Silbernagel et al 2017). The Apo(lipo)protein levels will be measured using immunoassays.
- Changes of inflammatory parameters in response to Alirocumab [ Time Frame: From baseline to 10 weeks of treatment ]Enzyme-linked immunosorbent assay kits will be used and C-reactive protein, as well as cytokines and adhesion molecules of special interest.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03559309
|Contact: Priska Hirschmann, MSc.||email@example.com|
|Medical University of Graz||Recruiting|
|Graz, Styria, Austria, A-8036|
|Contact: Priska Hirschmann +43 (316) 385 - 12344 firstname.lastname@example.org|
|Principal Investigator: Günther Silbernagel, MD. Ass.Prof.|
|Principal Investigator:||Günther Silbernagel, MD. Ass.Prof.||Medical University of Graz|