NCT05858099Active, not recruiting
The Early Detection and Progression of Subclinical Atherosclerosis in Psoriasis
The Early Detection and Progression of Subclinical Atherosclerosis in Psoriasis (EDSAP): Protocol for an Observational, Prospective Cohort Study
Source: ClinicalTrials.gov · Last updated 21 Sept 2023
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 120 (actual)
- First submitted
- 12 Apr 2023
- Start date
- 30 Jan 2020
- Primary completion date
- 31 Dec 2022
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Diseases
- Psoriasis
- NCT number
- NCT05858099
What you commit to
- Study type: Observational
- Participants enrolled: 120
- From 30 Jan 2020 to the primary completion date, 31 Dec 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients that have had a chest computed tomography scan in the previous year.
Other illness
- History of cardiovascular disease (myocardial infarction, angina pectoris, peripheral vascular disease, aortic aneurysm, angioplasty, cardiac surgery, atrial fibrillation or any other cardiological condition).
- History of transplantation with active immunosuppressive or immunomodulatory treatment.
- 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.
Other
- Patients undergoing oncological treatment.
- Patients with morbid obesity (body mass index ≥40 kg/m2).
- Pregnant or breastfeeding women.
Who the study is looking for
- Psoriasis patients eligible for biologic therapy.
- Psoriasis patients aged between 30 to 65 years.
Age in the registry: 30 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ramón y Cajal University Hospital Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.