Clinical Trial

The Early Detection and Progression of Subclinical Atherosclerosis in Psoriasis

Study acronym: EDSAP
Active, Not Recruiting
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Summary
The goal of this observational study is to identify new molecular and imaging markers associated with the presence of atherosclerosis and its progression in psoriasis. The main questions it aims to answer are: * To assess the prevalence, vascular distribution and burden of subclinical atherosclerosis in patients with psoriasis and its relationship with inflammatory biomarkers and cardiovascular (CV) risk algorithms using 2D vascular ultrasound (2DVUS) of carotid and femoral arteries, 3D vascular ultrasound (3DVUS) of carotid and femoral arteries and Coronary Computed Tomography Angiography (CCTA). * To characterize the composition of atherosclerotic plaques by CCTA and 3DVUS of the carotid and femoral arteries. * To evaluate the effect of different treatments used in psoriasis on the progression and characterisation of subclinical atherosclerosis in different arterial territories assessed by non-invasive imaging techniques. * To characterise the atherosclerosis process in patients with psoriasis using laboratory analysis and "-omics" technologies, as well as to evaluate changes at the molecular level after treatment of the skin disease. Participants will undergo 2 study visits: * At baseline, before starting biologic treatment for psoriasis. A 1-year follow up, after having completed one year under biologic treatment for psoriasis. * Both visits include a clinical interview, physical examination, fasting blood draw and assessment of atherosclerotic disease by non-invasive vascular imaging tests (2D/3DVUS and CCTA). * Participants may undergo an unscheduled clinical visit if the patient suffers a worsening of the psoriasis. This visit includes a clinical interview, physical examination and fasting blood draw.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-05-04.
Trial Details
NCT Number NCT05858099
Lead Sponsor Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Collaborators: HM Sanchinarro University Hospital, Hospital Universitario 12 de Octubre, Medstar Health Research Institute, Hospital Nacional de Parapléjicos de Toledo
Conditions Psoriasis, Atherosclerosis
Enrollment 120 participants
Start Date 2020-01-30
Primary Completion 2022-12-31 (estimated)
Study Completion 2030-12-31 (estimated)
Updated on ClinicalTrials.gov 2023-09-21