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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by University of California, San Diego.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Amgen
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01122095
First received: April 27, 2010
Last updated: May 28, 2010
Last verified: April 2010

April 27, 2010
May 28, 2010
April 2010
Not Provided
Obesity risk assessment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Body Mass Index; C-reactive protein (CRP)
Obesity risk assessment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Body Mass Index CRP
Complete list of historical versions of study NCT01122095 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Cross-sectional Evaluation of Biological Markers of Cardiovascular Disease in Children and Adolescents With Psoriasis
Cross-sectional Evaluation of Biological Markers of Cardiovascular Disease in Children and Adolescents With Psoriasis

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

Blood

Non-Probability Sample

case subjects, male or female, with typical psoriasis, with or without arthritis, ages 0 to 18 years of age and of all races and ethnicities control subjects, male or female, normal, health, non-soriatic subjects, 0 to 18 years of age.

  • Psoriasis
  • Obesity
  • Cardiovascular Risk
  • Inflammation
Not Provided
  • Psoriasis
    Children with psoriasis Age matched controls without psoriasis or other significant inflammatory disease
  • Control patient
    Age matched, without psoriasis or significant inflammatory disease
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
April 2011
Not Provided

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.
Both
up to 18 Years
Yes
Contact: Lawrence F. Eichenfield, MD 858-966-1700 leichenfield@rchsd.org
Contact: Donna Pascual, LVN 858-571-4295 dpascual@rchsd.org
United States
 
NCT01122095
20080414
No
Lawrence Eichenfield, University of California, San Diego
University of California, San Diego
Amgen
Principal Investigator: Lawrence F. Eichenfield, MD University of Calfornia, San Diego
University of California, San Diego
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP