Ignite Creation Date:
2024-05-06 @ 2:51 AM
Last Modification Date:
2024-10-26 @ 11:24 AM
Study NCT ID:
NCT02144857
Status:
RECRUITING
Last Update Posted:
2023-05-16
First Post:
2014-05-12
Brief Title:
Effects of Treatment With Biological Agents on Vascular and Cardiac Function in Psoriasis
Sponsor:
University of Athens
Organization:
University of Athens
Study Overview
Official Title:
Effects of Treatment With Biological Agents on Endothelial GlycocalyxArterial Elastic Properties Coronary Flow Myocardial Deformation and Twisting in Psoriasis Comparative Study With Patients With CAD or Untreated Hypertension
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Psoriasis has been associated with an increasing risk for atherosclerosis The investigators investigated whether surrogate markers of subclinical atherosclerosis vascular dysfunction and myocardial dysfunction are impaired in patients with psoriasis compared to normal controls coronary artery disease patients and untreated hypertension subjects The investigators also examined the effect of treatment with biological vs no biological agents on vascular and LV function in psoriasis
Detailed Description:
The investigators will compare patients with psoriasis with age and sex matched normal controls as well as patients with angiographically documented CAD and patients with untreated hypertension HYP used as positive control groups
Patients with psoriasis PS will be randomized to receive an anti-tumor necrosis-a TNF-a an anti- interleukin 1223 regimen an interleukin 17A antagonist apremilast inhibitor of phosphodiesterase-4 or a cyclosporine regimen
The anti-TNF-agent Etanercept will be given at a dose 50mg twice weekly for 12 weeks and after then once weekly
The anti-IL1223 regimen Ustekinumab will be given at a dose 45 mg at the first visit at 4 weeks and every 12 weeks if body weight is up to 90 kgr For body weight 90kgr dose will be adjusted accordingly
The IL-17A antagonist regimen namely secukinumab 300 mg SC at weeks 0 1 2 3 and 4 and 300 mg SC once monthly afterwards Apremilast will be given at a dose of 30mg orally twice daily Cyclosporine will be administered at a dose 25-3mgkgr daily
At baseline after 12 weeks and one year of treatment the investigators will measure
1 pulse wave velocity PWVc augmentation index AI central systolic blood pressure cSBP Complior Alam Medical and ArteriographTensioMed
2 flow-mediated dilation of the brachial artery FMD
3 carotid intima-media thickness IMT by ultrasonography
4 coronary flow reserve of the LAD CFR by Doppler echocardiography
5 EA of mitral annular velocities LV longitudinal GLS -strain and strain rate LongSr-ls peak twisting Tw -degpeak twisting Tw-degsecvelocityuntwisting at mitral valve opening unTw and untwisting unTw velocity using speckle tracking echocardiography
6 Perfused boundary region PBRof the sublingual arterial microvessels ranged from 5-25 microns using Sideview Darkfield imaging Microscan Glycocheck The PBR in microvessels is the cell-poor layer which results from the phase separation between the flowing red blood cells RBC and plasmaThe PBR includes the most luminal part of glycocalyx that does allow cell penetration Increased PBR is considered an accurate index of reduced endothelial glycocalyx thickness because of a deeper RBC penetration in the glycocalyx
7 Fetuin serum levels markers of oxidative stress such as malondialdehyde MDA serum levels protein carbonyls aw well as thrombosis and inflammation biomarkers
Patients with psoriasis PS will be randomized to receive an anti-tumor necrosis-a TNF-a an anti- interleukin 1223 regimen an interleukin 17A antagonist apremilast inhibitor of phosphodiesterase-4 or a cyclosporine regimen
The anti-TNF-agent Etanercept will be given at a dose 50mg twice weekly for 12 weeks and after then once weekly
The anti-IL1223 regimen Ustekinumab will be given at a dose 45 mg at the first visit at 4 weeks and every 12 weeks if body weight is up to 90 kgr For body weight 90kgr dose will be adjusted accordingly
The IL-17A antagonist regimen namely secukinumab 300 mg SC at weeks 0 1 2 3 and 4 and 300 mg SC once monthly afterwards Apremilast will be given at a dose of 30mg orally twice daily Cyclosporine will be administered at a dose 25-3mgkgr daily
At baseline after 12 weeks and one year of treatment the investigators will measure
1 pulse wave velocity PWVc augmentation index AI central systolic blood pressure cSBP Complior Alam Medical and ArteriographTensioMed
2 flow-mediated dilation of the brachial artery FMD
3 carotid intima-media thickness IMT by ultrasonography
4 coronary flow reserve of the LAD CFR by Doppler echocardiography
5 EA of mitral annular velocities LV longitudinal GLS -strain and strain rate LongSr-ls peak twisting Tw -degpeak twisting Tw-degsecvelocityuntwisting at mitral valve opening unTw and untwisting unTw velocity using speckle tracking echocardiography
6 Perfused boundary region PBRof the sublingual arterial microvessels ranged from 5-25 microns using Sideview Darkfield imaging Microscan Glycocheck The PBR in microvessels is the cell-poor layer which results from the phase separation between the flowing red blood cells RBC and plasmaThe PBR includes the most luminal part of glycocalyx that does allow cell penetration Increased PBR is considered an accurate index of reduced endothelial glycocalyx thickness because of a deeper RBC penetration in the glycocalyx
7 Fetuin serum levels markers of oxidative stress such as malondialdehyde MDA serum levels protein carbonyls aw well as thrombosis and inflammation biomarkers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None