Early Detection and Progression of Subclinical Atherosclerosis in Psoriasis (EDSAP): protocol for an observational, single-centre, prospective cohort study.

Introduction: Life expectancy of patients with psoriasis is reduced by 4-5 years due to cardiovascular disease with an increased risk of myocardial infarction at an earlier age compared with the general population. This increased risk is independent of traditional cardiovascular risk factors and higher in moderate-to-severe forms of psoriasis. Inflammation may play a key role in the development of atherosclerosis in these patients.
Methods and Analysis: A prospective cohort study, Early Detection and Progression of Subclinical Atherosclerosis in Psoriasis (EDSAP), was initiated in January 2020 to investigate the presence and progression of subclinical atherosclerosis in patients with psoriasis. 120 patients aged 30-65 years and eligible for biological treatment have been recruited at Hospital Ramón y Cajal in Madrid, Spain. Patients undergo a baseline visit, and 1-year follow-up visit after starting biological therapy. Each visit includes: assessment of cardiovascular risk factors, screening for subclinical atherosclerosis by two-dimensional/three-dimensional ultrasound of carotid and femoral arteries, cardiac CT of coronary arteries and blood sampling. All baseline visits were completed by December 2022, and the remaining follow-up visits will be concluded by the end of 2023. The EDSAP study aims to identify new molecular and imaging markers associated with the presence of atherosclerosis and its progression in a chronic inflammatory state such as psoriasis. This has the potential to: (1) help improve primary cardiovascular prevention strategies in these patients; (2) understand the effect of biological drugs on the cardiovascular system; and (3) serve as a model for understanding atherosclerosis in other chronic inflammatory diseases.
Ethics and Dissemination: The study protocol has been approved by the Institutional Review Board of the Hospital Ramón y Cajal in Madrid. We will present our findings at national and international congresses, and peer-reviewed journals.
Trial Registration Number: NCT05858099.
Competing Interests: Competing interests: NNM is a full-time US government employee and has served as a consultant for several pharmaceutical companies, receiving grants and/or research funding; and as a principal investigator for the NIH receiving grants and/or research funding. JMG served as a consultant for several pharmaceutical companies, receiving honoraria and research grants (to the Trustees of the University of Pennsylvania). JMG is a co-patent holder of resiquimod for treatment of cutaneous T-cell lymphoma. JMG receives honoraria from multiple organisms, for being a Deputy Editor for the Journal of Investigative Dermatology, Chief Medical Editor for Healio Psoriatic Disease. He is also a member of the Board of Directors for the International Psoriasis Council, receiving no honoraria. AG-C has served as a consultant for several pharmaceutical companies receiving grants/other payments. MAB-M has served as a consultant for several pharmaceutical companies receiving honoraria. LF-F, JS, EB-R, MGB, PJ and CA-JdA have no interests to disclose.
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