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

NCT ID: NCT01122095

Last Updated: 2010-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Psoriasis Obesity Cardiovascular Risk Inflammation

Keywords

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Psoriasis Cardiovascular risk

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Psoriasis

Children with psoriasis Age matched controls without psoriasis or other significant inflammatory disease

No interventions assigned to this group

Control patient

Age matched, without psoriasis or significant inflammatory disease

No interventions assigned to this group

Eligibility Criteria

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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.


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

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.


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.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Amgen

INDUSTRY

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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University of California, San Diego

Principal Investigators

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Lawrence F. Eichenfield, MD

Role: PRINCIPAL_INVESTIGATOR

University of Calfornia, San Diego

Locations

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Rady Children's Hospital Dermatolgoy

San Diego, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lawrence F. Eichenfield, MD

Role: CONTACT

Phone: 858-966-1700

Email: [email protected]

Donna Pascual, LVN

Role: CONTACT

Phone: 858-571-4295

Email: [email protected]

Facility Contacts

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Donna Pascual, LVN

Role: primary

Ann Funk, RN, CCRC

Role: backup

References

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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.

Reference Type BACKGROUND

Other Identifiers

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20080414

Identifier Type: -

Identifier Source: org_study_id