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

28 mei 2010 bijgewerkt door: 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.

Studie Overzicht

Toestand

Onbekend

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Verwacht)

100

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • California
      • San Diego, California, Verenigde Staten, 92123
        • Werving
        • Rady Children's Hospital Dermatolgoy
        • Contact:
        • Contact:
          • Ann Funk, RN, CCRC
          • Telefoonnummer: 4295 858-576-1700
          • E-mail: afunk@rchsd.org
        • Onderonderzoeker:
          • Wynnis Tom, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Niet ouder dan 18 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Obesity risk assessment
Tijdsspanne: 6 months
Body Mass Index; C-reactive protein (CRP)
6 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of California, San Diego

Medewerkers

Amgen

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

  • 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.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 april 2010

Studie voltooiing (Verwacht)

1 april 2011

Studieregistratiedata

Eerst ingediend

27 april 2010

Eerst ingediend dat voldeed aan de QC-criteria

11 mei 2010

Eerst geplaatst (Schatting)

12 mei 2010

Updates van studierecords

Laatste update geplaatst (Schatting)

31 mei 2010

Laatste update ingediend die voldeed aan QC-criteria

28 mei 2010

Laatst geverifieerd

1 april 2010

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 20080414

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