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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):
Henrik Fox, Johann Wolfgang Goethe University Hospital

Tracking Information
First Submitted Date December 12, 2011
First Posted Date January 27, 2012
Last Update Posted Date December 23, 2013
Study Start Date December 2011
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 26, 2012)
Identification of cardiovascular risk in patients with systemic Lupus Erythematodes [ Time Frame: one year ]
Identification of cardiovascular risk in patients with systemic Lupus Erythematodes
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title CArdiovascular Risk Assessment STudy in Lupus Erythemathodes (CASTLE)
Official Title CArdiovascular Risk Assessment STudy in Lupus Erythemathodes (CASTLE): Studie Zur Detektion Des kardiovaskulären Risikos in Patienten Mit Systemischem Lupus Erythematodes
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.
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 Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Every participant will provide 20 ml Serum for further laboratory analysis
Sampling Method Non-Probability Sample
Study Population Patients with or without systemic Lupus erythematosus
Condition Systemic Lupus Erythematosus
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 26, 2012)
90
Original Estimated Enrollment Same as current
Actual Study Completion Date December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with systemic Lupus erythematosus

Exclusion Criteria:

  • Patients without systemic Lupus erythematosus
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT01520155
Other Study ID Numbers sleffm001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Henrik Fox, Johann Wolfgang Goethe University Hospital
Study Sponsor Johann Wolfgang Goethe University Hospital
Collaborators Not Provided
Investigators
Study Chair: Joachim R Ehrlich, MD Frankfurt University Academic Medical Center
PRS Account Johann Wolfgang Goethe University Hospital
Verification Date December 2013