Cholesterol Embolism Systemic Clinical Trial
Official title:
Efficacy of Prednisone in Patients With Severe Systemic Atheroembolism (Cholesterol Cristal Embolism)
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment