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 high...

Full description

Bibliographic Details
Main Authors: Leticia Fernandez-Friera, Jorge Solis, Joel M Gelfand, Carlota Abbad-Jaime de Aragón, Emilio Berna-Rico, María Asunción Ballester-Martinez, Pedro Jaén, Nehal N Mehta, Álvaro González-Cantero, María G Barderas
Format: Article
Language:English
Published: BMJ Publishing Group 2023-09-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/13/9/e072455.full
_version_ 1797650755716382720
author Leticia Fernandez-Friera
Jorge Solis
Joel M Gelfand
Carlota Abbad-Jaime de Aragón
Emilio Berna-Rico
María Asunción Ballester-Martinez
Pedro Jaén
Nehal N Mehta
Álvaro González-Cantero
María G Barderas
author_facet Leticia Fernandez-Friera
Jorge Solis
Joel M Gelfand
Carlota Abbad-Jaime de Aragón
Emilio Berna-Rico
María Asunción Ballester-Martinez
Pedro Jaén
Nehal N Mehta
Álvaro González-Cantero
María G Barderas
author_sort Leticia Fernandez-Friera
collection DOAJ
description 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.
first_indexed 2024-03-11T16:06:02Z
format Article
id doaj.art-5b02c8156c504e24a8d19be98785b887
institution Directory Open Access Journal
issn 2044-6055
language English
last_indexed 2024-03-11T16:06:02Z
publishDate 2023-09-01
publisher BMJ Publishing Group
record_format Article
series BMJ Open
spelling doaj.art-5b02c8156c504e24a8d19be98785b8872023-10-25T02:15:07ZengBMJ Publishing GroupBMJ Open2044-60552023-09-0113910.1136/bmjopen-2023-072455Early Detection and Progression of Subclinical Atherosclerosis in Psoriasis (EDSAP): protocol for an observational, single-centre, prospective cohort studyLeticia Fernandez-Friera0Jorge Solis1Joel M Gelfand2Carlota Abbad-Jaime de Aragón3Emilio Berna-Rico4María Asunción Ballester-Martinez5Pedro Jaén6Nehal N Mehta7Álvaro González-Cantero8María G Barderas9Cardiology, Atria Clinic, Madrid, SpainCardiology, Hospital Universitario 12 de Octubre, Madrid, SpainDermatology, University of Pennsylvania, Philadelphia, Pennsylvania, USADermatology, Hospital Universitario Ramon y Cajal, Madrid, SpainDermatology, Hospital Universitario Ramon y Cajal, Madrid, SpainDermatology, Hospital Universitario Ramon y Cajal, Madrid, SpainDermatology, Hospital Universitario Ramon y Cajal, Madrid, SpainCardiology, George Washington Medical Center, Washington, DC, USADermatology, Hospital Universitario Ramon y Cajal, Madrid, SpainVascular Physiopathology, Hospital Nacional de Parapléjicos, IDISCAM, Toledo, SpainIntroduction 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.https://bmjopen.bmj.com/content/13/9/e072455.full
spellingShingle Leticia Fernandez-Friera
Jorge Solis
Joel M Gelfand
Carlota Abbad-Jaime de Aragón
Emilio Berna-Rico
María Asunción Ballester-Martinez
Pedro Jaén
Nehal N Mehta
Álvaro González-Cantero
María G Barderas
Early Detection and Progression of Subclinical Atherosclerosis in Psoriasis (EDSAP): protocol for an observational, single-centre, prospective cohort study
BMJ Open
title Early Detection and Progression of Subclinical Atherosclerosis in Psoriasis (EDSAP): protocol for an observational, single-centre, prospective cohort study
title_full Early Detection and Progression of Subclinical Atherosclerosis in Psoriasis (EDSAP): protocol for an observational, single-centre, prospective cohort study
title_fullStr Early Detection and Progression of Subclinical Atherosclerosis in Psoriasis (EDSAP): protocol for an observational, single-centre, prospective cohort study
title_full_unstemmed Early Detection and Progression of Subclinical Atherosclerosis in Psoriasis (EDSAP): protocol for an observational, single-centre, prospective cohort study
title_short Early Detection and Progression of Subclinical Atherosclerosis in Psoriasis (EDSAP): protocol for an observational, single-centre, prospective cohort study
title_sort early detection and progression of subclinical atherosclerosis in psoriasis edsap protocol for an observational single centre prospective cohort study
url https://bmjopen.bmj.com/content/13/9/e072455.full
work_keys_str_mv AT leticiafernandezfriera earlydetectionandprogressionofsubclinicalatherosclerosisinpsoriasisedsapprotocolforanobservationalsinglecentreprospectivecohortstudy
AT jorgesolis earlydetectionandprogressionofsubclinicalatherosclerosisinpsoriasisedsapprotocolforanobservationalsinglecentreprospectivecohortstudy
AT joelmgelfand earlydetectionandprogressionofsubclinicalatherosclerosisinpsoriasisedsapprotocolforanobservationalsinglecentreprospectivecohortstudy
AT carlotaabbadjaimedearagon earlydetectionandprogressionofsubclinicalatherosclerosisinpsoriasisedsapprotocolforanobservationalsinglecentreprospectivecohortstudy
AT emiliobernarico earlydetectionandprogressionofsubclinicalatherosclerosisinpsoriasisedsapprotocolforanobservationalsinglecentreprospectivecohortstudy
AT mariaasuncionballestermartinez earlydetectionandprogressionofsubclinicalatherosclerosisinpsoriasisedsapprotocolforanobservationalsinglecentreprospectivecohortstudy
AT pedrojaen earlydetectionandprogressionofsubclinicalatherosclerosisinpsoriasisedsapprotocolforanobservationalsinglecentreprospectivecohortstudy
AT nehalnmehta earlydetectionandprogressionofsubclinicalatherosclerosisinpsoriasisedsapprotocolforanobservationalsinglecentreprospectivecohortstudy
AT alvarogonzalezcantero earlydetectionandprogressionofsubclinicalatherosclerosisinpsoriasisedsapprotocolforanobservationalsinglecentreprospectivecohortstudy
AT mariagbarderas earlydetectionandprogressionofsubclinicalatherosclerosisinpsoriasisedsapprotocolforanobservationalsinglecentreprospectivecohortstudy