Prevalence and Risk Factors asSOciated With CArdiac comorbiDIty in psoriAsis

NCT04950218 | Recruiting DMC

• 1 other identifier: PSOCADIA
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

In a prospective cohort study (n = 1.000), the investigators aim to investigate the correlation between cardiac biomarkers and advanced echocardiography and determine whether these are prognostic markers of heart disease in patients suffering from psoriasis.

Conditions

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

Keywords

Psoriasis; Echocardiography; Advanced echocardiography; Biomarkers; Mortality; Cardiovascular mortality

Outcome Measures

Primary Outcomes (9)

• Cardiovascular mortality

  2 year follow-up

• Cardiovascular mortality

  5 year follow-up

• Cardiovascular mortality

  10 year follow-up

• Myocardial infarction

  2 year follow up

• Myocardial infarction

  5 year follow up

• Myocardial infarction

  10 year follow up

• Coronary revascularization

  Percutaneous coronary intervention or coronary artery bypass graft

  2 year follow up

• Coronary revascularization

  Percutaneous coronary intervention or coronary artery bypass graft

  5 year follow up

• Coronary revascularization

  Percutaneous coronary intervention or coronary artery bypass graft

  10 year follow up

Secondary Outcomes (9)

• All-cause mortality

  2 year follow up

• All-cause mortality

  5 year follow up

• All-cause mortality

  10 year follow up

• Admission with cardiac heart failure (CHF)

  2 year follow up

• Admission with cardiac heart failure (CHF)

  5 year follow up

Study Arms (2)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Psoriasis patients will be recruited prospectively from the Outpatient Clinic, Department of Dermato- Allergology, Herlev and Gentofte University Hospital, and Bispebjerg \& Frederiksberg Hospital, Denmark. Eligible psoriasis patients will be identified from the daily outpatient program, at the Department of Dermato-Allergology. 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.

You may qualify if:

• Patients 18 years or older with a diagnosis of psoriasis will be invited to participate

You may not qualify if:

• Patients not able to cooperate to the study
• Patients unable understand and sign informed consent

Sponsors & Collaborators

• Herlev and Gentofte Hospital: lead

Study Sites (1)

Department of Cardiology, Herlev and Gentofte University Hospital, University of Copenhagen

Hellerup, Copenhagne, 2900, Denmark

RECRUITING

Related Publications (26)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Hemoglobin A1c (HbA1c), hemoglobin level, fasting plasma glucose, ALAT, cholesterol, triglyceride levels, creatinine, potassium, sodium, TSH Specific biomarkers: HsCRP, hsTNT and proBNP

MeSH Terms

Conditions

Psoriasis; Cardiovascular Diseases; Guttate Psoriasis; Ventricular Dysfunction, Left; Myocardial Infarction; Myocardial Ischemia; Heart Failure; Stroke; Heart Diseases; Heart Failure, Systolic; Heart Failure, Diastolic

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Ventricular Dysfunction; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Tor Biering-Sørensen, MD, PhD, MPH

  Department of Cardiology, Herlev and Gentofte University Hospital, University of Copenhagen

  STUDY DIRECTOR

• Claus Zachariae, MD, DMSc

  Department of Dermato-Allergology, Herlev and Gentofte University Hospital, University of Copenhagen

  STUDY DIRECTOR

• Lone Skov, MD, PhD, DMSc

  Department of Dermato-Allergology, Herlev and Gentofte University Hospital, University of Copenhagen

  STUDY DIRECTOR

• Gunnar Gislason, MD, PhD

  Department of Cardiology, Herlev and Gentofte University Hospital, University of Copenhagen

  STUDY DIRECTOR

Central Study Contacts

Maria F Dons, MD

CONTACT

+4560604780; mariaflarupdons@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, fellow

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: July 6, 2021
• Study Start: September 1, 2021
• Primary Completion (Estimated): October 1, 2034
• Study Completion (Estimated): October 1, 2034
• Last Updated: September 15, 2025

Record last verified: 2025-09

Locations

DK (1)