CArdiovascular Risk Assessment STudy in Lupus Erythemathodes (CASTLE)
This study is currently recruiting participants.
Verified January 2012 by Johann Wolfgang Goethe University Hospitals
Sponsor:
Johann Wolfgang Goethe University Hospitals
Information provided by (Responsible Party):
Henrik Fox, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01520155
First received: December 12, 2011
Last updated: January 26, 2012
Last verified: January 2012
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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
| Estimated Enrollment: | 90 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01520155
Contacts
| Contact: Henrik Fox, MD | +49696301 ext 7387 | henrik.fox@kgu.de |
| Contact: Joachim R Ehrlich, MD | +49696301 ext 7387 | j.ehrlich@em.uni-frankfurt.de |
Locations
| Germany | |
| Frankfurt University Academic Medical Center | Recruiting |
| Frankfurt am Main, Hessen, Germany, 60590 | |
| Contact: Henrik Fox, MD +49696301 ext 7387 henrik.fox@kgu.de | |
| Contact: Joachim R Ehrlich, MD +49696301 ext 7387 j.ehrlich@em.uni-frankfurt.de | |
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: | January 26, 2012 |
| 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 May 23, 2013