Psoriasis Clinical Trial
Official title:
Effects of Treatment With Biological Agents on Endothelial Glycocalyx,Arterial Elastic Properties, Coronary Flow, Myocardial Deformation and Twisting in Psoriasis. Comparative Study With Patients With CAD or Untreated Hypertension.
Psoriasis has been associated with an increasing risk for atherosclerosis. The investigators investigated whether surrogate markers of subclinical atherosclerosis, vascular dysfunction and myocardial dysfunction are impaired in patients with psoriasis compared to normal controls ,coronary artery disease patients and untreated hypertension subjects. The investigators also examined the effect of treatment with biological vs no biological agents on vascular and LV function in psoriasis.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 31, 2023 |
Est. primary completion date | September 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - patients with psoriasis - Age and sex matched patients with CAD, with untreated hypertension and healthy subjects Exclusion Criteria: - for psoriasis patients were presence of wall motion abnormalities and ejection fraction = 50%, psoriatic arthritis, history of acute coronary syndrome, familial hyperlipidemia, insulin dependent-diabetes mellitus, chronic obstructive pulmonary disease or asthma, moderate or severe valvular heart disease, primary cardiomyopathies and malignant tumors. CAD was excluded in psoriasis patients by absence of clinical history, angina and reversible myocardial ischemia, as assessed by dobutamine stress echocardiography or thallium scintigraphy - regarding the group of CAD patients, we only included patients without history of ST elevation myocardial infarction in order to exclude the presence of transmural scar compromising myocardial function indices. Thus, CAD patients with wall motion abnormalities and ejection fraction of = 50% were excluded. In addition, exclusion criteria, were history of acute coronary syndrome without ST-segment elevation within the last year, familial hyperlipidemia, insulin dependent-diabetes mellitus, chronic obstructive pulmonary disease or asthma, moderate or severe valvular heart disease, primary cardiomyopathies and malignant tumor - in normal controls, CAD was excluded by the presence of normal ECG, absence of clinical history and absence of reversible ischemia by means of treadmill test or dobutamine stress echocardiography |
Country | Name | City | State |
---|---|---|---|
Greece | Attikon Hospital | Athens |
Lead Sponsor | Collaborator |
---|---|
University of Athens |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on endothelial function in psoriasis | Comparison of effect (improvement or deterioration) of treatment with biological agents (anti-tumor necrosis factor-a, anti-interleukin 12/23, anti-interleukin 17A, or apremilast regimen) with the effects of cyclosporine on endothelial function as assessed by flow mediated dilatation of the brachial artery, coronary flow reserve and endothelial glycocalyx thickness | 12 weeks | |
Primary | Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on vascular function in psoriasis | Comparison of effect (improvement or deterioration) of treatment with biological agents (anti-tumor necrosis factor-a, anti-interleukin 12/23, anti-interleukin 17A, or apremilast regimen) with the effects of cyclosporine on vascular function as assessed by pulse wave velocity, augmentation index and central aortic blood pressure, | 12 weeks | |
Primary | Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on cardiac function in psoriasis | Comparison of effect (improvement or deterioration) of treatment with biological agents (anti-tumor necrosis factor-a, anti-interleukin 12/23 ,anti-interleukin 17A, or apremilast regimen) with the effects of cyclosporine on cardiac function as assessed by longitudinal myocardial deformation, twisting and untwisting of the left ventricle | 12 weeks | |
Secondary | Differences and similarities in endothelial function between psoriasis and control groups | Differences in endothelial function between psoriasis and normal controls, and similarities in endothelial function between psoriasis and coronary artery disease patients and untreated hypertension patients before and after 4 week of anti-inflammatory treatment in patients with psoriasis .The following parameters will be compared among the study subgroups endothelial function as assessed by flow mediated dilatation of the brachial artery, coronary flow reserve and endothelial glycocalyx thickness | 0 and 12 weeks | |
Secondary | Differences and similarities in vascular function between psoriasis and control groups | Differences in vascular function between psoriasis and normal controls, and similarities in vascular function between psoriasis and coronary artery disease patients and untreated hypertension patients before and after 4 week of anti-inflammatory treatment in patients with psoriasis .The following parameters will be compared among the study subgroups vascular function as assessed by pulse wave velocity, augmentation index and central aortic blood pressure, | 0 and 12 weeks | |
Secondary | Differences and similarities in cardiac function between psoriasis and control groups | Differences in cardiac function between psoriasis and normal controls, and similarities in cardiac function between psoriasis and coronary artery disease patients and untreated hypertension patients before and after 4 week of anti-inflammatory treatment in patients with psoriasis The following parameters will be compared among the study subgroups cardiac function as assessed by longitudinal myocardial deformation, twisting and untwisting of the left ventricle | 0 and 12 weeks | |
Secondary | Effects of anti-inflammatory treatment on prognosis for major adverse cardiovascular events | Effects of anti-inflammatory treatment on myocardial infarction, stroke, hospitalization because of heart failure, and cardiovascular death | 4-year follow-up |
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