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

28 mai 2010 mis à jour par: University of California, San Diego

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.

Aperçu de l'étude

Statut

Inconnue

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Anticipé)

100

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • California
      • San Diego, California, États-Unis, 92123
        • Recrutement
        • Rady Children's Hospital Dermatolgoy
        • Contact:
        • Contact:
          • Ann Funk, RN, CCRC
          • Numéro de téléphone: 4295 858-576-1700
          • E-mail: afunk@rchsd.org
        • Sous-enquêteur:
          • Wynnis Tom, MD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

Pas plus vieux que 18 ans (Enfant, Adulte)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Psoriasis
Children with psoriasis Age matched controls without psoriasis or other significant inflammatory disease
Control patient
Age matched, without psoriasis or significant inflammatory disease

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Obesity risk assessment
Délai: 6 months
Body Mass Index; C-reactive protein (CRP)
6 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of California, San Diego

Collaborateurs

Amgen

Les enquêteurs

  • Chercheur principal: Lawrence F. Eichenfield, MD, University of Calfornia, San Diego

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

  • 1. Neimann AL, Shin DB, Wang X, Margolis DJ, Troxel AB , Gelfand JM. Prevalence of cardiovascular risk factors in patients with psoriasis. J Am Acad Dermatol 2006;55:829-35. 2. Gelfand J, Neimann A, Shin D et al. Risk of myocardial infarction in patients with psoriasis. JAMA. 2006;296:1735-1741. 3. Gelfand J, Troxel B, Lewis J et al. The risk of mortality in patients with psoriasis: Results from a population-based study. Arch Dermatol. 2007;143(12):1493-1499 4. Kelishadi R, Ardalan G, Gheiratmand R, Adeli K, Delavari A, and Majdzadeh R et al. Pediatric metabolic syndrome and associated anthropometric indices: the CASPIAN study. Acta Paediatrica, 2006. 95: 1625-1634. 5. Goodman E, Dolan L, Morrison J and Daniels S. Factor Analysis of Clustered Cardiovascular Risks in Adolescence. Circulation 2005; 111: 1970-1977. 6. Schwimmer JB, Pardee PE, Lavine JE, Blumkin AK, Cook S. Cardiovascular Risk Factors and the Metabolic Syndrome in Pediatric Nonalcoholic Fatty Liver Disease. Circulation. 2008 June. 118:277-283.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 avril 2010

Achèvement de l'étude (Anticipé)

1 avril 2011

Dates d'inscription aux études

Première soumission

27 avril 2010

Première soumission répondant aux critères de contrôle qualité

11 mai 2010

Première publication (Estimation)

12 mai 2010

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

31 mai 2010

Dernière mise à jour soumise répondant aux critères de contrôle qualité

28 mai 2010

Dernière vérification

1 avril 2010

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 20080414

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