Rosuvastatin Prevent Contrast Induced Acute Kidney Injury in Patients With Diabetes

Study Overview
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Brief Summary
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The number of cardiac angiography and percutaneous coronary interventions (PCI) has increased steadily in recent years. This has resulted in the increasing incidence of contrast-induced acute kidney injury (CIAKI). Major risk factors for CIAKI include older age, diabetes mellitus (DM), chronic kidney disease(CKD), the concurrent use of nephrotoxic drugs, hemodynamic instability, etc. Importantly, DM appears to act as a risk multiplier, meaning that in a patient with CKD it amplifies the risk of CIAKI. The aim of this multicenter prospective, randomized, controlled study is to evaluate whether statins treatment during the perioperative period would reduce the risk of CIAKI in a high-risk population of patients with both type 2 diabetes mellitus (T2DM) and CKD undergoing coronary angiography or noncoronary angiography, and evaluate the influence of such potential benefit on short-term outcome.

Official Title
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Multicenter Randomized Controlled Study of Rosuvastatin for Prevention of Contrast Induced Acute Kidney Injury in Patients With Diabetes and Slight to Moderate Renal Insufficient

Conditions
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Diabetes Mellitus, Chronic Kidney Disease

Intervention / Treatment
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* Drug: rosuvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Planned diagnostic coronary or peripheral artery angiography T2DM CKD stages 2 and 3, eGFR 30 to 89ml/min per 1.73m2 Statin naive, or not on statin treatment for at least 14 days Withdrawal metformin or aminophylline for 48h before angiography Total iodixanol volume Exclusion Criteria: Hypersensitivity to iodine-containing compounds and statins Type 1 diabetes mellitus Ketoacidosis Lactic acidosis CKD stages 1,4 or 5 (eGFR≥90ml/min per 1.73m2 or eGFR<30ml/min per 1.73m2) STEMI NYHA class IV or hemodynamic instability Administration of any iodinated CM within 14 days before randomization LDL-C<1.82mmol/L（70mg/dL） Hepatic dysfunction (ALT 3 times greater than upper normal limit) Thyreoid insufficiency renal artery Stenosis(unilateral >70％ or bilateral stenosis>50％)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>perioperative rosuvastatin administration for at least 5 dosages | Drug: rosuvastatin<br>* rosuvastatin<br>|
| Placebo Comparator: control<br>blank control of perioperative statin administration | Drug: rosuvastatin<br>* rosuvastatin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| An absolute increase in SCr >=0.5mg/dL（>=44.2μmmol/L）or a >= 25% increase in SCr from baseline to 72h after the procedure |  | 72 h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The composite of hospitalization for aggravated renal function, acute renal failure, dialysis or hemofiltration, aggravated at least 1 class of heart function, acute left ventricular failure or death from all causes. |  | 30 d | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus, chronic kidney disease, contrast induced acute kidney injury, angiography