Status:
TERMINATED
Efficacy of Prednisone in Patients With Severe Systemic Atheroembolism (Cholesterol Cristal Embolism)
Lead Sponsor:
University Hospital, Toulouse
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Cholesterol Embolism Systemic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Cholesterol cristal embolization (CCE) is an orphan multisystem vascular condition occurring in elderly with severe atherosclerosis. In most patients, avoiding the precipitating factors and combinati...
Detailed Description
Erosion of atheromatous plaque results in release of cholesterol crystal embolism that ultimately occlude medium-sized arterioles and capillaries of the kidney, skin, gastrointestinal tract and centra...
Eligibility Criteria
Inclusion
- Biopsy-proven CCE or clinically diagnosed CCE as assessed on the 3 following criteria : presence of one or more precipitating factors renal function deterioration in atherosclerotic patients ischemic changes of the extremities or demonstration of retinal embolism
- Severe CCE as defined by either acute renal failure (S creatinine \> 125 micromol/l and increase \> 25 % of baseline), or severe abdominal changes (hemorrhage, infarction, perforation or weight loss \> 5 % of body weight) or severe central nervous system neurological complication
Exclusion
- CCE unproven, or restricted to one organ, or non-active contraindication to prednisone.
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT01452100
Start Date
June 1 2011
End Date
December 1 2015
Last Update
May 9 2016
Active Locations (1)
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1
CHU Toulouse service néphrologie
Toulouse, Toulouse, France, 31052