CArdiovascular Risk Assessment STudy in Lupus Erythemathodes (CASTLE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Henrik Fox, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01520155
First received: December 12, 2011
Last updated: December 20, 2013
Last verified: December 2013
  Purpose

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
Systemic Lupus Erythematosus

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • Identification of cardiovascular risk in patients with systemic Lupus Erythematodes [ Time Frame: one year ] [ Designated as safety issue: No ]
    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


Enrollment: 90
Study Start Date: December 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01520155

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

No publications provided

Responsible Party: Henrik Fox, Principal Investigator, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT01520155     History of Changes
Other Study ID Numbers: sleffm001
Study First Received: December 12, 2011
Last Updated: December 20, 2013
Health Authority: Ethik-Kommission des Fachbereichs Medizin der Johann Wolfgang Goethe-Universität: Germany

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

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

ClinicalTrials.gov processed this record on September 15, 2014