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

28 maggio 2010 aggiornato da: 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.

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Anticipato)

100

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Nome: Lawrence F. Eichenfield, MD
Numero di telefono: 858-966-1700
Email: leichenfield@rchsd.org

Backup dei contatti dello studio

Nome: Donna Pascual, LVN
Numero di telefono: 858-571-4295
Email: dpascual@rchsd.org

Luoghi di studio

Stati Uniti
- California
  - San Diego, California, Stati Uniti, 92123
    - Reclutamento
    - Rady Children's Hospital Dermatolgoy
    - Contatto:
      
      Donna Pascual, LVN
      
      Numero di telefono: 4295 858-576-1700
      
      Email: dpascual@rchsd.org
    - Contatto:
      
      Ann Funk, RN, CCRC
      
      Numero di telefono: 4295 858-576-1700
      
      Email: afunk@rchsd.org
    - Sub-investigatore:
      
      Wynnis Tom, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Non più vecchio di 18 anni (Bambino, Adulto)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

Inclusion Criteria:

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

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
Persons residing in the US.
Subjects 0 to 18 years of age.
Subjects/Guardians willing and able to comply with the requirements of the study.
Subjects/Guardians willing and able to give informed consent.
The subject is in general good health in the opinion of the investigator.

Exclusion Criteria:

Over 18 years of age.
Subject has had a diagnosis of congenital heart disease.
Subject has had any cardiac catheterizations or surgeries.
Subject has taken any cardiac medications (calcium channel blockers, beta blockers, vasotropic medicines) within the past 2 years.
Subjects determined to have atypical psoriasis or isolated palmoplantar psoriasis.
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.
Having autoimmune or immunodeficiency disease.
Presence of active systemic fungal, bacterial, or viral infections.
Presence of active systemic malignancy.
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.
Inability or unwillingness of a participant to give written informed consent.

Control Inclusion Criteria:

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

Control Exclusion Criteria:

Over 18 years of age.
Subject has had a diagnosis of congenital heart disease.
Subject has had any cardiac catheterizations or surgeries.
Subject has taken any cardiac medications (calcium channel blockers, beta blockers, vasotropic medicines) within the past 2 years.
Subjects determined to have psoriasis of any type or a family history (first degree relative) with psoriasis.
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.
Having autoimmune or immunodeficiency disease.
Presence of active systemic fungal, bacterial, or viral infections.
Presence of active systemic malignancy.
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.
Inability or unwillingness of a participant to give written informed consent.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte Gruppo / Coorte Un gruppo o sottogruppo di partecipanti a uno studio osservazionale che viene valutato per gli esiti biomedici o sanitari.
Psoriasis Children with psoriasis Age matched controls without psoriasis or other significant inflammatory disease
Control patient Age matched, without psoriasis or significant inflammatory disease

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Obesity risk assessment Lasso di tempo: 6 months	Body Mass Index; C-reactive protein (CRP)	6 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of California, San Diego

Collaboratori

Amgen

Investigatori

Investigatore principale: Lawrence F. Eichenfield, MD, University of Calfornia, San Diego

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

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.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 aprile 2010

Completamento dello studio (Anticipato)

1 aprile 2011

Date di iscrizione allo studio

Primo inviato

27 aprile 2010

Primo inviato che soddisfa i criteri di controllo qualità

11 maggio 2010

Primo Inserito (Stima)

12 maggio 2010

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

31 maggio 2010

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 maggio 2010

Ultimo verificato