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The Early Detection and Progression of Subclinical Atherosclerosis in Psoriasis

NCT05858099 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2023-09-21

No results posted yet for this study

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

Sponsors & Collaborators

  • HM Sanchinarro University Hospital

    collaborator OTHER

  • Hospital Universitario 12 de Octubre

    collaborator OTHER

  • Medstar Health Research Institute

    collaborator OTHER

  • Hospital Nacional de Parapléjicos de Toledo

    collaborator OTHER

  • Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

    lead OTHER

Principal Investigators

  • Álvaro González Cantero, MD, PhD · Fundación Hospital Ramón y Cajal

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-30
Primary Completion
2022-12-31
Completion
2030-12-31

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05858099 on ClinicalTrials.gov