Efficacy of Prednisone in Patients With Severe Systemic Atheroembolism (Cholesterol Cristal Embolism) (MECCORT)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cholesterol Embolism Systemic |
Drug: prednisone Other: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Efficacy of Prednisone in Patients With Severe Systemic Atheroembolism (Cholesterol Cristal Embolism) |
- 1-year survival and 1-year renal survival (composite criteria) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Number and duration of hospitalization(s) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Number and duration of hospitalization(s)
- course of renal function [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]stable, deterioration or improvement of serum creatinine - defined by changes > 20 % compared to base line
- number of cardiovascular events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]acute coronary syndrome, stroke, heart failure, critical lower member ischemia, digestive ischemia
- prednisone tolerance [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]as regard to de novo diabetes mellitus, and severe psychiatric or infectious episode (requiring hospitalization).
| Estimated Enrollment: | 140 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: prednisone
• Patients enrolled into the study will be treated with prednisone, 20 mg/day (if body weight <70 kg ; or 25mg/d if body weight >70 kg) for 1 month, then tapered to 12.5 mg/d (month 2) and 7.5 mg/d (month 3) and stop. In both groups, patients will be treated according to expert advice including use of statins (according to French Health Agency recommendation), a RAS inhibitor and supportive treatment (including nutrition, treatment of heart failure, and dialysis).
|
Drug: prednisone
Patients enrolled into the study will be treated with prednisone, 20 mg/day (if body weight <70 kg ; or 25mg/d if body weight >70 kg) for 1 month, then tapered to 12.5 mg/d (month 2) and 7.5 mg/d (month 3) and stop. In both groups, patients will be treated according to expert advice including use of statins (according to French Health Agency recommendation), a RAS inhibitor and supportive treatment (including nutrition, treatment of heart failure, and dialysis).
Other Name: Cortancyl
|
|
Placebo Comparator: placebo
Patients enrolled into the study will be treated with placebo, 20 mg/day (if body weight <70 kg ; or 25mg/d if body weight >70 kg) for 1 month, then tapered to 12.5 mg/d (month 2) and 7.5 mg/d (month 3) and stop. In both groups, patients will be treated according to expert advice including use of statins (according to French Health Agency recommendation), a RAS inhibitor and supportive treatment (including nutrition, treatment of heart failure, and dialysis).
|
Other: placebo
• Patients enrolled into the study will be treated with placebo, 20 mg/day (if body weight <70 kg ; or 25mg/d if body weight >70 kg) for 1 month, then tapered to 12.5 mg/d (month 2) and 7.5 mg/d (month 3) and stop. In both groups, patients will be treated according to expert advice including use of statins (according to French Health Agency recommendation), a RAS inhibitor and supportive treatment (including nutrition, treatment of heart failure, and dialysis).
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Dominique Chauveau, PhD | 0561323283 ext 33 | chauveau.d@chu-toulouse.fr |
| Contact: Antoine Huart, MD | 0561323029 ext 33 | huart.a@chu-toulouse.fr |
| France | |
| CHU Toulouse service néphrologie | Recruiting |
| Toulouse, France, 31052 | |
| Contact: Dominique Chauveau, PHD | |
| Sub-Investigator: Antoine Huart, MD | |
| Study Director: | Dominique Chauveau, PhD | University Hospital, Toulouse |
| Principal Investigator: | Antoine Huart, MPD | University Hospital, Toulouse |
More Information
No publications provided
| Responsible Party: | University Hospital, Toulouse |
| ClinicalTrials.gov Identifier: | NCT01452100 History of Changes |
| Other Study ID Numbers: | 1003701, 2010-021467-33 |
| Study First Received: | September 15, 2011 |
| Last Updated: | January 22, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by University Hospital, Toulouse:
|
embolism cholesterol cristal creatinine |
renal insufficiency prednisone systemic atheroembolism |
Additional relevant MeSH terms:
|
Prednisone Embolism Embolism, Cholesterol Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Embolism, Fat Glucocorticoids |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 22, 2013