PsoriasisEDSAPNCT05858099
The Early Detection and Progression of Subclinical Atherosclerosis in Psoriasis
An observational study of Psoriasis and Atherosclerosis, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Psoriasis, Atherosclerosis
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 30 Jan 2020to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Psoriasis patients diagnosed with psoriasis clinically by an expert physician and deemed suitable for biologic therapy by the investigator
Who may be able to join
- Psoriasis patients eligible for biologic therapy.
- Psoriasis patients aged between 30 to 65 years.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Early Detection and Progression of Subclinical Atherosclerosis in Psoriasis (EDSAP): Protocol for an Observational, Prospective Cohort Study
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.
Read more
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.
Read the 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.
- Conditions
- Psoriasis, Atherosclerosis
- Keywords
- Imaging, Inflammation, Coronary computed tomography angiography, Biomarkers, Cardiovascular disease, Molecular biomarkers
- Medical subject headings
- Psoriasis, Atherosclerosis, Inflammation, Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 4-6 years
Secondary outcomes (3)
CCTA Quantitative Assessment of plaques by plaque volume (mm3)
To quantitatively assess atheroma plaques from the coronary artery by CCTA, measured in mm3
Measured: 4-6 years
Carotid and femoral 3DVUS quantitative plaque assessment by plaque volume (mm3)
Quantitatively assess atheroma plaques in the femoral and carotid arteries by 3DVUS, measured in mm3.
Measured: 4-6 years
Proteomic signature characterization by Liquid Chromatography- Mass Spectrometry (LC-MS/MS)
To characterize potential proteomic biomarkers by LC-MS/MS
Measured: 4-6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start30 Jan 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Collaborators
- HM Sanchinarro University Hospital, Hospital Universitario 12 de Octubre, Medstar Health Research Institute, Hospital Nacional de Parapléjicos de Toledo
- Responsible party
- Principal investigator, Alvaro Gonzalez Cantero, Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Investigators
- Álvaro González Cantero, MD, PhD, Principal investigator, Fundación Hospital Ramón y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05858099
- Sponsor's protocol ID
- CI-BIOB-058-01
- Acronym
- EDSAP
- Status last verified
- Sep 2023
- First submitted
- 12 Apr 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37751953
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Early Detection and Progression of Subclinical Atherosclerosis in Psoriasis (EDSAP): Protocol for an Observational, Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05858099
- Acronym / sponsor ID
- EDSAP / CI-BIOB-058-01
- Conditions
- Psoriasis, Atherosclerosis
- Keywords
- Imaging, Inflammation, Coronary computed tomography angiography, Biomarkers, Cardiovascular disease, Molecular biomarkers
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUniversity, hospital or other
- Collaborators
- HM Sanchinarro University Hospital, Hospital Universitario 12 de Octubre, Medstar Health Research Institute, Hospital Nacional de Parapléjicos de Toledo
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 15 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Psoriasis patients diagnosed with psoriasis clinically by an expert physician and deemed suitable for biologic therapy by the investigator
Key inclusion criteria (2 listed)
- Psoriasis patients eligible for biologic therapy.
- Psoriasis patients aged between 30 to 65 years.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
3 secondary outcomes
CCTA Quantitative Assessment of plaques by plaque volume (mm3)
Time frame: 4-6 years
Carotid and femoral 3DVUS quantitative plaque assessment by plaque volume (mm3)
Time frame: 4-6 years
Proteomic signature characterization by Liquid Chromatography- Mass Spectrometry (LC-MS/MS)
Time frame: 4-6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Derived from this study: PubMed 37751953Abbad-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Álvaro González Cantero, MD, PhD principal investigator
Fundación Hospital Ramón y Cajal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis and Atherosclerosis, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of subclinical coronary artery atherosclerosis in patients with psoriasis by CCTA (time frame: 4-6 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05858099, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.