Cross-sectional Evaluation of Biological Markers of Cardiovascular Disease in Children and Adolescents With Psoriasis

• Conditions: Cardiovascular Risk; Inflammation; Obesity; Psoriasis

• Registration Number: NCT01122095
• Lead Sponsor: University of California, San Diego

Brief Summary

Hypothesis 1: Patients with psoriasis will have clinical and laboratory assessments differing from control patients.

Hypothesis 2: Patients with psoriasis will have laboratory alterations that correlate with other clinical characteristics of their psoriasis.

Detailed Description

Psoriasis was initially considered an inflammatory condition primarily of the skin. However, advances in medical knowledge have allowed insight into the wide-ranging systemic effects of long-term uncontrolled inflammation, thus shifting the concept of psoriasis from an inflammatory disease restricted to the skin to a systemic process. Adults w/ psoriasis have higher rates of obesity, hypertension, diabetes, hyperlipidemia and smoking and the prevalence of each risk factor increases as the extent of psoriasis increases.1 It is uncertain if any of this relates to a behavioral reaction to having psoriasis or as a separate part of the disease process. Inflammation has a role in the pathogenesis of cardiovascular disease most noted by multiple observational studies of psoriasis patients which demonstrate an increased risk of arterial or venous events, notably myocardial infarction, cerebrovascular events, pulmonary emboli, cardiovascular death or mortality overall. Specifically, Gelfand et. al. show an increased relative risk for myocardial infarction and an increased hazard ratio for mortality in patients with severe psoriasis, but most notably, show highest risk in younger adult patients. There is a paucity of data on risks with psoriasis in the pediatric and adolescent age group.

Study Timeline

• Status Verified: 2010-04
• Study Start: 2010-04
• Study First Submitted: 2010-04-27
• Study First Submitted QC: 2010-05-11
• Study First Posted: 2010-05-12
• Last Update Submitted: 2010-05-28
• Last Update Posted: 2010-05-31
• Study Completion: 2011-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Subjects of any race or ethnicity who meet all of the following criteria are eligible for enrollment into the study:

1. The subject has a diagnosis of typical psoriasis, with or without arthritis, based on the clinical evaluation by an investigator or a prior diagnosis by a pediatric dermatologist
2. Persons residing in the US.
3. Subjects 0 to 18 years of age.
4. Subjects/Guardians willing and able to comply with the requirements of the study.
5. Subjects/Guardians willing and able to give informed consent.
6. The subject is in general good health in the opinion of the investigator.

Exclusion Criteria

1. Over 18 years of age.
2. Subject has had a diagnosis of congenital heart disease.
3. Subject has had any cardiac catheterizations or surgeries.
4. Subject has taken any cardiac medications (calcium channel blockers, beta blockers, vasotropic medicines) within the past 2 years.
5. Subjects determined to have atypical psoriasis or isolated palmoplantar psoriasis.
6. Subject diagnosed with any other systemic inflammatory disease including atopic dermatitis, severe acne vulgaris, inflammatory bowel disease, juvenile idiopathic arthritis, connective tissue disease and other similar conditions.
7. Having autoimmune or immunodeficiency disease.
8. Presence of active systemic fungal, bacterial, or viral infections.
9. Presence of active systemic malignancy.
10. Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.
11. Inability or unwillingness of a participant to give written informed consent.

Control Inclusion Criteria:

1. Age up to 18 years.
2. Ability and willingness to provide informed consent.

Control Exclusion Criteria:

1. Over 18 years of age.
2. Subject has had a diagnosis of congenital heart disease.
3. Subject has had any cardiac catheterizations or surgeries.
4. Subject has taken any cardiac medications (calcium channel blockers, beta blockers, vasotropic medicines) within the past 2 years.
5. Subjects determined to have psoriasis of any type or a family history (first degree relative) with psoriasis.
6. Subject diagnosed with any other systemic inflammatory disease including atopic dermatitis, severe acne vulgaris, inflammatory bowel disease, juvenile idiopathic arthritis, connective tissue disease and other similar conditions.
7. Having autoimmune or immunodeficiency disease.
8. Presence of active systemic fungal, bacterial, or viral infections.
9. Presence of active systemic malignancy.
10. Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.
11. Inability or unwillingness of a participant to give written informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Obesity risk assessment	6 months	Body Mass Index; C-reactive protein (CRP)

Trial Locations

Locations (1)

Rady Children's Hospital Dermatolgoy; 🇺🇸 San Diego, California, United States