The Early Detection and Progression of Subclinical Atherosclerosis in Psoriasis

Condition(s) studied

Study 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.

Eligibility

Primary outcome measure(s)

• Prevalence of subclinical coronary artery atherosclerosis in patients with psoriasis by CCTA — 4-6 years
  To determine presence / absence of atheroma plaques in the coronary artery by CCTA
• Prevalence of subclinical atherosclerosis in carotid and femoral arteries of patients with psoriasis by 2DVUS — 4-6 years
  To determine presence / absence of atheroma plaques by 2DVUS for femoral and carotid arteries.

Trial sites (1)

More Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal trials in Spain

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