The Early Detection and Progression of Subclinical Atherosclerosis in Psoriasis

NCT05858099 | Active Not Recruiting

• 1 other identifier: CI-BIOB-058-01
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psoriasis; Atherosclerosis

Keywords

Imaging; Inflammation; Coronary computed tomography angiography; Biomarkers; Cardiovascular disease; Molecular biomarkers

Outcome Measures

Primary Outcomes (2)

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

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

  4-6 years

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

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

  4-6 years

Secondary Outcomes (3)

• CCTA Quantitative Assessment of plaques by plaque volume (mm3)

  4-6 years

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

  4-6 years

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

  4-6 years

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Psoriasis patients diagnosed with psoriasis clinically by an expert physician and deemed suitable for biologic therapy by the investigator

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal: lead
• HM Sanchinarro University Hospital: collaborator
• Hospital Universitario 12 de Octubre: collaborator
• Medstar Health Research Institute: collaborator
• Hospital Nacional de Parapléjicos de Toledo: collaborator

Study Sites (1)

Ramón y Cajal University Hospital

Madrid, 28034, Spain

Location

Related Publications (1)

• Abbad-Jaime de Aragon C, Berna-Rico E, Ballester-Martinez MA, Jaen P, Solis J, Barderas MG, Fernandez-Friera L, N Mehta N, Gelfand JM, Gonzalez-Cantero A. Early Detection and Progression of Subclinical Atherosclerosis in Psoriasis (EDSAP): protocol for an observational, single-centre, prospective cohort study. BMJ Open. 2023 Sep 26;13(9):e072455. doi: 10.1136/bmjopen-2023-072455.

  PMID: 37751953 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples.

MeSH Terms

Conditions

Psoriasis; Atherosclerosis; Inflammation; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Álvaro González Cantero, MD, PhD

  Fundación Hospital Ramón y Cajal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: May 15, 2023
• Study Start: January 30, 2020
• Primary Completion: December 31, 2022
• Study Completion (Estimated): December 31, 2030
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

ES (1)