Cross-sectional Evaluation of Biological Markers of Cardiovascular Disease in Children and Adolescents With Psoriasis
28. Mai 2010 aktualisiert von: 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.
Studienübersicht
Status
Unbekannt
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Voraussichtlich)
100
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
California
-
San Diego, California, Vereinigte Staaten, 92123
- Rekrutierung
- Rady Children's Hospital Dermatolgoy
-
Kontakt:
- Donna Pascual, LVN
- Telefonnummer: 4295 858-576-1700
- E-Mail: dpascual@rchsd.org
-
Kontakt:
- Ann Funk, RN, CCRC
- Telefonnummer: 4295 858-576-1700
- E-Mail: afunk@rchsd.org
-
Unterermittler:
- Wynnis Tom, MD
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
Nicht älter als 18 Jahre (Kind, Erwachsene)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
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.
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
|---|
|
Psoriasis
Children with psoriasis Age matched controls without psoriasis or other significant inflammatory disease
|
|
Control patient
Age matched, without psoriasis or significant inflammatory disease
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Obesity risk assessment
Zeitfenster: 6 months
|
Body Mass Index; C-reactive protein (CRP)
|
6 months
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Mitarbeiter
Ermittler
- Hauptermittler: Lawrence F. Eichenfield, MD, University of Calfornia, San Diego
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. April 2010
Studienabschluss (Voraussichtlich)
1. April 2011
Studienanmeldedaten
Zuerst eingereicht
27. April 2010
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
11. Mai 2010
Zuerst gepostet (Schätzen)
12. Mai 2010
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
31. Mai 2010
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
28. Mai 2010
Zuletzt verifiziert
1. April 2010
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 20080414
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .