Cross-sectional Evaluation of Biological Markers of Cardiovascular Disease in Children and Adolescents With Psoriasis
28 de mayo de 2010 actualizado por: 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.
Descripción general del estudio
Estado
Desconocido
Condiciones
Descripción detallada
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 de estudio
De observación
Inscripción (Anticipado)
100
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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California
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San Diego, California, Estados Unidos, 92123
- Reclutamiento
- Rady Children's Hospital Dermatolgoy
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Contacto:
- Donna Pascual, LVN
- Número de teléfono: 4295 858-576-1700
- Correo electrónico: dpascual@rchsd.org
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Contacto:
- Ann Funk, RN, CCRC
- Número de teléfono: 4295 858-576-1700
- Correo electrónico: afunk@rchsd.org
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Sub-Investigador:
- Wynnis Tom, MD
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
No mayor que 18 años (Niño, Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Psoriasis
Children with psoriasis Age matched controls without psoriasis or other significant inflammatory disease
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Control patient
Age matched, without psoriasis or significant inflammatory disease
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Obesity risk assessment
Periodo de tiempo: 6 months
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Body Mass Index; C-reactive protein (CRP)
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6 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Lawrence F. Eichenfield, MD, University of Calfornia, San Diego
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de abril de 2010
Finalización del estudio (Anticipado)
1 de abril de 2011
Fechas de registro del estudio
Enviado por primera vez
27 de abril de 2010
Primero enviado que cumplió con los criterios de control de calidad
11 de mayo de 2010
Publicado por primera vez (Estimar)
12 de mayo de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
31 de mayo de 2010
Última actualización enviada que cumplió con los criterios de control de calidad
28 de mayo de 2010
Última verificación
1 de abril de 2010
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 20080414
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .