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CArdiovascular Risk Assessment STudy in Lupus Erythemathodes (CASTLE) (CASTLE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01520155
Recruitment Status : Completed
First Posted : January 27, 2012
Last Update Posted : December 23, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The key of this prospective study is to identify a potentially increased cardiovascular risk in patients with systemic Lupus erythematodes, with and without renal affection. Three groups of patients will be compared.

Condition or disease
Systemic Lupus Erythematosus

Detailed Description:
Key of this prospective study is to identify a potentially increased cardiovascular risk in patients with systemic Lupus erythematodes, with and without renal affection. Three group of patients will be compared as followed. First group are patients with known systemic Lupus erythematodes without renal affection, second group are patients with known systemic Lupus erythematodes with renal affection and the third group are patients with a non-autoimmun chronic kidney disease

Study Design

Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: CArdiovascular Risk Assessment STudy in Lupus Erythemathodes (CASTLE): Studie Zur Detektion Des kardiovaskulären Risikos in Patienten Mit Systemischem Lupus Erythematodes
Study Start Date : December 2011
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Systemic lupus erythematosus with renal affection
30 patients will be investigated suffering from a known systemic lupus erythematosus with renal affection
Systemic lupus erythematosus without renal affection
30 patients will be investigated suffering from a known systemic lupus erythematosus without renal affection
Non-autoimmune kidney disease
Patients with non-systemic, non-autoimmune kidney disease


Outcome Measures

Primary Outcome Measures :
  1. Identification of cardiovascular risk in patients with systemic Lupus Erythematodes [ Time Frame: one year ]
    Identification of cardiovascular risk in patients with systemic Lupus Erythematodes


Biospecimen Retention:   Samples Without DNA
Every participant will provide 20 ml Serum for further laboratory analysis

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with or without systemic Lupus erythematosus
Criteria

Inclusion Criteria:

  • Patients with systemic Lupus erythematosus

Exclusion Criteria:

  • Patients without systemic Lupus erythematosus
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01520155


Locations
Germany
Frankfurt University Academic Medical Center
Frankfurt am Main, Hessen, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Investigators
Study Chair: Joachim R Ehrlich, MD Frankfurt University Academic Medical Center
More Information

Responsible Party: Henrik Fox, Principal Investigator, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT01520155     History of Changes
Other Study ID Numbers: sleffm001
First Posted: January 27, 2012    Key Record Dates
Last Update Posted: December 23, 2013
Last Verified: December 2013

Keywords provided by Henrik Fox, Johann Wolfgang Goethe University Hospitals:
lupus erythematosus
cardiovascular risk

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases