Efficacy of Prednisone in Patients With Severe Systemic Atheroembolism (Cholesterol Cristal Embolism)
Information source: University Hospital, Toulouse
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cholesterol Embolism Systemic
Intervention: prednisone (Drug); placebo (Other)
Phase: Phase 2
Status: Recruiting
Sponsored by: University Hospital, Toulouse Official(s) and/or principal investigator(s): Dominique Chauveau, PhD, Study Director, Affiliation: University Hospital, Toulouse Antoine Huart, MPD, Principal Investigator, Affiliation: University Hospital, Toulouse
Overall contact: Dominique Chauveau, PhD, Phone: 0561323283, Ext: 33, Email: chauveau.d@chu-toulouse.fr
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.
Clinical Details
Official title: Efficacy of Prednisone in Patients With Severe Systemic Atheroembolism (Cholesterol Cristal Embolism)
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: 1-year survival and 1-year renal survival (composite criteria)
Secondary outcome: Number and duration of hospitalization(s)course of renal function number of cardiovascular events prednisone tolerance
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 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- CCE unproven, or restricted to one organ, or non-active contraindication to
prednisone.
Locations and Contacts
Dominique Chauveau, PhD, Phone: 0561323283, Ext: 33, Email: chauveau.d@chu-toulouse.fr
CHU Toulouse service néphrologie, Toulouse 31052, France; Recruiting Dominique Chauveau, PHD Antoine Huart, MD, Sub-Investigator
Additional Information
Starting date: June 2011
Last updated: August 18, 2015
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