Clinical Trial: Efficacy of Prednisone in Patients With Severe Systemic Atheroembolism (Cholesterol Cristal Embolism)

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Efficacy of Prednisone in Patients With Severe Systemic Atheroembolism (Cholesterol Cristal Embolism)

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 combination of statin and RAS inhibitor are recommended.

The lack of randomized controlled trial in CCE precludes significant advances. The investigators decided to assess whether prednisone started early, at mild dosage and for a short period prevents death and progression to end-stage renal failure in patients with severe CCE, as compared to placebo.

Detailed Summary:

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 central nervous system. The diagnosis relies on histopathological demonstration of cholesterol cristal embolism in any target organ, or can be assumed if the 3 following criteria are met (1) presence of one or more precipitating factors (2) renal function deterioration in atherosclerotic patients (3) ischemic changes of the extremities or demonstration of retinal CCE. Despite the dismal prognosis in multisystem CCE mortality the optimal treatment remains unknown.

In most patients, avoiding the precipitating factors and combination of statin and RAS inhibitor are recommended. The benefit of prednisone is uncertain, but its dramatic impact has been underlined in several short retrospective series, even with moderate daily dosage (0,2-0,5 mg/kg). However, adverse side effects of steroid therapy in uremic elderly with CCE have not been assessed. In addition, the optimal duration of the treatment has not been assessed. The lack of randomized controlled trial in CCE precludes significant advances. The investigators decided to assess whether prednisone started early, at mild dosage and for a short period prevents death and progression to end-stage renal failure in patients with severe CCE, as compared to placebo.

Sponsor: University Hospital, Toulouse

Current Primary Outcome: 1-year survival and 1-year renal survival (composite criteria) [ Time Frame: 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Number and duration of hospitalization(s) [ Time Frame: 1 year ]
  Number and duration of hospitalization(s)
• course of renal function [ Time Frame: 1 year ]
  stable, deterioration or improvement of serum creatinine - defined by changes > 20 % compared to base line
• number of cardiovascular events [ Time Frame: 1 year ]
  acute coronary syndrome, stroke, heart failure, critical lower member ischemia, digestive ischemia
• prednisone tolerance [ Time Frame: 1 year ]
  as regard to de novo diabetes mellitus, and severe psychiatric or infectious episode (requiring hospitalization).

Original Secondary Outcome: Same as current

Information By: University Hospital, Toulouse

Dates:
Date Received: September 15, 2011
Date Started: June 2011
Date Completion:
Last Updated: May 6, 2016
Last Verified: May 2016