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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
History of Changes
  Purpose

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.


Condition
Psoriasis
Obesity
Cardiovascular Risk
Inflammation

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Cross-sectional Evaluation of Biological Markers of Cardiovascular Disease in Children and Adolescents With Psoriasis

Resource links provided by NLM:

MedlinePlus related topics: Obesity Psoriasis
U.S. FDA Resources

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Obesity risk assessment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Body Mass Index; C-reactive protein (CRP)


Biospecimen Retention:   Samples With DNA

Blood


Estimated Enrollment: 100
Study Start Date: April 2010
Estimated Study Completion Date: April 2011
Groups/Cohorts
Psoriasis
Children with psoriasis Age matched controls without psoriasis or other significant inflammatory disease
Control patient
Age matched, without psoriasis or significant inflammatory disease

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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01122095

Contacts
Contact: Lawrence F. Eichenfield, MD 858-966-1700 leichenfield@rchsd.org
Contact: Donna Pascual, LVN 858-571-4295 dpascual@rchsd.org

Locations
United States, California
Rady Children's Hospital Dermatolgoy Recruiting
San Diego, California, United States, 92123
Contact: Donna Pascual, LVN     858-576-1700 ext 4295     dpascual@rchsd.org    
Contact: Ann Funk, RN, CCRC     858-576-1700 ext 4295     afunk@rchsd.org    
Sub-Investigator: Wynnis Tom, MD            
Sponsors and Collaborators
University of California, San Diego
Amgen
Investigators
Principal Investigator: Lawrence F. Eichenfield, MD University of Calfornia, San Diego
  More Information

No publications provided

Responsible Party: Lawrence Eichenfield, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01122095     History of Changes
Other Study ID Numbers: 20080414
Study First Received: April 27, 2010
Last Updated: May 28, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
Psoriasis
Cardiovascular risk

Additional relevant MeSH terms:
Cardiovascular Diseases
Inflammation
Obesity
Psoriasis
Pathologic Processes
Overnutrition
 Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2013