Cross-sectional Evaluation of Biological Markers of Cardiovascular Disease in Children and Adolescents With Psoriasis
Recruitment status was Recruiting
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| First Received Date ICMJE | April 27, 2010 | ||||||||
| Last Updated Date | May 28, 2010 | ||||||||
| Start Date ICMJE | April 2010 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
Obesity risk assessment [ Time Frame: 6 months ] [ Designated as safety issue: No ] Body Mass Index; C-reactive protein (CRP) |
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| Original Primary Outcome Measures ICMJE |
Obesity risk assessment [ Time Frame: 6 months ] [ Designated as safety issue: No ] Body Mass Index CRP |
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| Change History | Complete list of historical versions of study NCT01122095 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Cross-sectional Evaluation of Biological Markers of Cardiovascular Disease in Children and Adolescents With Psoriasis | ||||||||
| Official Title ICMJE | Cross-sectional Evaluation of Biological Markers of Cardiovascular Disease in Children and Adolescents With Psoriasis | ||||||||
| Brief Summary | 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: Blood |
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| 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. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 100 | ||||||||
| Estimated Completion Date | April 2011 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Subjects of any race or ethnicity who meet all of the following criteria are eligible for enrollment into the study:
Exclusion Criteria:
Control Inclusion Criteria:
Control Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | up to 18 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01122095 | ||||||||
| Other Study ID Numbers ICMJE | 20080414 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Lawrence Eichenfield, University of California, San Diego | ||||||||
| Study Sponsor ICMJE | University of California, San Diego | ||||||||
| Collaborators ICMJE | Amgen | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of California, San Diego | ||||||||
| Verification Date | April 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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