Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
- - Patients 18 years or older with a diagnosis of psoriasis will be invited to participate.
- - Patients not able to cooperate to the study.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Herlev and Gentofte Hospital|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Tor Biering-Sørensen, MD, PhD, MPHClaus Zachariae, MD, DMScLone Skov, MD, PhD, DMScGunnar Gislason, MD, PhD|
|Principal Investigator Affiliation||Department of Cardiology, Herlev and Gentofte University Hospital, University of CopenhagenDepartment of Dermato-Allergology, Herlev and Gentofte University Hospital, University of CopenhagenDepartment of Dermato-Allergology, Herlev and Gentofte University Hospital, University of CopenhagenDepartment of Cardiology, Herlev and Gentofte University Hospital, University of Copenhagen|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Psoriasis, Cardiovascular Diseases, Cardiovascular Risk Factor, Cardiovascular Pathology, Psoriasis Vulgaris, Psoriatic Nail, Psoriasis Face, Psoriasis Guttate, Psoriasis Gyrata, Psoriasis Diffusa, Psoriasis Palmaris, Psoriasis Annularis, Psoriasis Circinata, Psoriasis Plantaris, Psoriasis Universalis, Psoriasis Geographica, Left Ventricular Dysfunction, Myocardial Infarction, Myocardial Ischemia, Heart Failure, Stroke, Heart Diseases, Heart Failure, Systolic, Heart Failure, Diastolic|
Cardiovascular disease (CVD) is mainly caused by atherosclerosis, now considered as a chronic inflammatory disease of blood vessels. Likewise, psoriasis is a chronic and relapsing, inflammatory, immune mediated disease. Atherosclerosis and psoriasis therefore share several pathophysiological traits. Previous epidemiological studies have demonstrated a high prevalence of cardiovascular (CV) risk factors in psoriasis patients, including metabolic syndrome, cigarette smoking, obesity, hypertension, diabetes mellitus, insulin resistance and dyslipidemia(1-11). Furthermore, studies suggest that psoriasis may be an independent risk factor for cardiovascular disease such as myocardial infarction(12-15), coronary artery disease(9, 16, 17), stroke(18-20) and cardiovascular mortality(18, 21, 22). In addition, psoriasis is associated with surrogate markers of cardiovascular disease and increased platelet activity, e.g. endothelial dysfunction and coronary calcification. The fundamental role of inflammation in cardiovascular disease has prompted interest in the predictive capability of numerous biomarkers such as hsCRP, hsTNT, suPAR and pro-BNP that detect subclinical levels of inflammation. Hence, these inflammatory biomarkers might be able to reveal a pro-inflammatory disease state that represent a significant risk of CVD. Likewise, novel myocardial deformation imaging echocardiography, such as Tissue Doppler Imaging (TDI) and 2-dimensional speckle tracking echocardiography (2DSE), have been able to demonstrate subtle signs of myocardial dysfunction in high risk persons from the general population despite a normal convention echocardiography(24-26). These advanced echocardiographic techniques are able to detect asymptomatic reduced left ventricular function, which is not visible by the naked eye. Early identification of this group of patients is of utmost importance in order to initiate appropriate treatment in attempt to minimize further left ventricular damage and ensure better quality of life. By evaluating biomarkers and advanced echocardiography in a prospective study setting it might be possible to establish the prevalence of cardiac dysfunction and disease in patients with psoriasis and to identify patients who have miniscule signs of cardiac dysfunction and therefore are in high risk of future fulminant cardiovascular disease. Population. The Psoriasis Echo Study is a prospective cohort study consisting of a random sample of 1.000 consecutive patients from a population of outpatients with psoriasis and a control group. Psoriasis patients will be recruited prospectively from the Outpatient Clinic, Department of Dermato- Allergology, Herlev and Gentofte University Hospital, Denmark.
- - Inclusion criteria: In order to approximate a random sample as accurate as possible all patients 18 years or older with a diagnosis of psoriasis will be invited to participate.
- - Exclusion criteria: Patients not able to cooperate to the study and patients unable understand and sign informed consent will be excluded from the study.
- - Psoriasis.
- - Stroke.
- - Chronic obstructive lung disease (COLD) - Periferal artery disease (PAD) - Atrial fibrillation/atrial flutter and/or other cardiac arrythmias.
- - Pacemaker.
- - Diabetes type 1 and type 2.
- - Kidney disease.
- - Hypertension.
- - Hypercholesterolemia.
- - Valvular disease (mitral, aortic, tricuspid and pulmonic valve disease) - Previous heart surgery.
- - Ischemic heart disease including non-invasive ischemic imaging results, prior MI, prior revascularization and/or CABG.
- - Heart failure.
- - Sleep apnea.
- - Thyroid disease or other metabolic disease.
- - Assessment severity of the psoriasis by the psoriasis area.
- - Determination of severity index (PASI) - Dermatology Life Quality Index (DLQI) Other data collected at inclusion consult: - Blood pressure.
- - ECG.
- - Body mass index.
- - Hemoglobin A1c (HbA1c), hemoglobin level, fasting plasma glucose, ALAT, cholesterol, triglyceride levels, creatinine, potassium, sodium, TSH.
- - Specific biomarkers: HsCRP , hsTNT and proBNP.
- - where possible - 3D Echocardiography in the left lateral decubitus position.
- - Primary outcomes: Cardiovascular mortality, myocardial infarction, revascularization (percutaneous coronary intervention/coronary artery bypass graft) - Secondary outcomes: All-cause mortality, admission with cardiac heart failure (CHF) and admission with stroke.
- - as outlined - and examine their ability to 1) detect cardiac involvement and 2) provide prognostic information.
: Psoriasis patients
Eligible psoriasis patients will be identified from the daily outpatient program, at the Department of Dermato-Allergology, that is the department will provide the patient's contact information to the project group. As most outpatient clinic psoriasis is classified as moderate to severe, in order to approximate a random sample as accurate as possible including patients with mild psoriasis, all people with a diagnosis of psoriasis will a general invitation to participate in the study through appropriate channels such as the Danish Psoriasis Foundation's newsletter.
: Control group
The control group will consist of a retrospective random sample of around 1.000 patients from the general population examined in the 4th and 5th Copenhagen City Heart Study, 2001-2003 and 2011-2014 (ClinicalTrials.gov identifier NCT02993172, I-Suite no. 03741, National Committee on Health Research Ethics approval HEH-2015-045). Existing data from the Copenhagen City Heart Study will be transferred to the current study and will include personal identification number from the Central Office of Civil Registration, echocardiographic assessments, electrocardiograms as well as health related data (health conditions including symptoms, risk factors for cardiovascular disease, medication, prior clinical and/or paraclinical assessments including blood test results and procedures relevant to psoriasis and potential heart disease).
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.