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NCT Number: NCT05858099

The Early Detection and Progression of Subclinical Atherosclerosis in Psoriasis

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Psoriasis Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Vascular Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ramón y Cajal University Hospital

Madrid, 28034, Spain

About this study

Life expectancy of patients with psoriasis is reduced by 4-5 years due to cardiovascular (CV) disease with an increased risk of myocardial infarction at an earlier age compared to general population. This increased risk is independent of traditional CV 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. 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 in order to help improve primary CV prevention strategies, understand the effect of biologic drugs on the CV system and serve as a model for understanding atherosclerosis in other chronic inflammatory diseases.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Psoriasis patients eligible for biologic therapy.
  • Psoriasis patients aged between 30 to 65 years.

Exclusion criteria

  • History of cardiovascular disease (myocardial infarction, angina pectoris, peripheral vascular disease, aortic aneurysm, angioplasty, cardiac surgery, atrial fibrillation or any other cardiological condition).
  • Patients undergoing oncological treatment.
  • History of transplantation with active immunosuppressive or immunomodulatory treatment.
  • Patients with morbid obesity (body mass index ≥40 kg/m2).
  • Patients with diabetes mellitus.
  • Patients with chronic liver disease.
  • Patients with chronic kidney disease (glomerular filtration rate <60 mL/min/1.73 m2).
  • Patients with other chronic inflammatory disease, presence of any pathology that decreases life expectancy to less than 3 years, or any disease or condition that could affect adherence to study procedures.
  • Patients that have had a chest computed tomography scan in the previous year.
  • Pregnant or breastfeeding women.

Treatment and study plan

Primary outcomes

  1. Prevalence of subclinical coronary artery atherosclerosis in patients with psoriasis by CCTA

    Time frame: 4-6 years

    To determine presence / absence of atheroma plaques in the coronary artery by CCTA

  2. Prevalence of subclinical atherosclerosis in carotid and femoral arteries of patients with psoriasis by 2DVUS

    Time frame: 4-6 years

    To determine presence / absence of atheroma plaques by 2DVUS for femoral and carotid arteries.

Secondary outcomes

  1. CCTA Quantitative Assessment of plaques by plaque volume (mm3)

    Time frame: 4-6 years

    To quantitatively assess atheroma plaques from the coronary artery by CCTA, measured in mm3

  2. Carotid and femoral 3DVUS quantitative plaque assessment by plaque volume (mm3)

    Time frame: 4-6 years

    Quantitatively assess atheroma plaques in the femoral and carotid arteries by 3DVUS, measured in mm3.

  3. Proteomic signature characterization by Liquid Chromatography- Mass Spectrometry (LC-MS/MS)

    Time frame: 4-6 years

    To characterize potential proteomic biomarkers by LC-MS/MS

Sponsors and collaborators

Lead sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Other

Collaborators

  • HM Sanchinarro University Hospital
  • Hospital Nacional de Parapléjicos de Toledo
  • Hospital Universitario 12 de Octubre
  • Medstar Health Research Institute

Registry information

Official study title

The Early Detection and Progression of Subclinical Atherosclerosis in Psoriasis (EDSAP): Protocol for an Observational, Prospective Cohort Study

Acronym: EDSAP

Important dates

Study start
2020
Primary completion
2022
Study completion
2030
First posted
May 15, 2023
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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