Clinical trial NCT05858099: The Early Detection and Progression of Subclinical Atherosclerosis in Psoriasis
Official title: The Early Detection and Progression of Subclinical Atherosclerosis in Psoriasis (EDSAP): Protocol for an Observational, Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Psoriasis
Atherosclerosis
Keywords: Imaging
Inflammation
Coronary computed tomography angiography
Biomarkers
Cardiovascular disease
Molecular biomarkers
Lead sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
Collaborators: name: HM Sanchinarro University Hospital
name: Hospital Universitario 12 de Octubre
name: Medstar Health Research Institute
name: Hospital Nacional de Parapléjicos de Toledo
First posted: 2023-05-15
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of subclinical coronary artery atherosclerosis in patients with psoriasis by CCTA
timeFrame: 4-6 years
measure: Prevalence of subclinical atherosclerosis in carotid and femoral arteries of patients with psoriasis by 2DVUS
timeFrame: 4-6 years
Secondary outcomes:
measure: CCTA Quantitative Assessment of plaques by plaque volume (mm3)
timeFrame: 4-6 years
measure: Carotid and femoral 3DVUS quantitative plaque assessment by plaque volume (mm3)
timeFrame: 4-6 years
measure: Proteomic signature characterization by Liquid Chromatography- Mass Spectrometry (LC-MS/MS)
timeFrame: 4-6 years
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Ramón y Cajal University Hospital
Study officials:
affiliation: Fundación Hospital Ramón y Cajal
name: Álvaro González Cantero, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: