Renal PRotection Against Contrast mEdium-induced nephroPathy in High Risk Patients undErgoing Coronary Angiography

Study Overview
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Brief Summary
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This study evaluates the efficacy of remote ischemic preconditioning on preventing contrast medium-induced nephropathy in a population of high risk patients undergoing coronary angiography. Half of participants will receive a preconditioning procedure while the other half will receive a sham procedure.

Detailed Description
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Contrast medium-induced nephropathy has a big impact on clinical outcomes in patients suffering from renal insufficiency who undergo percutaneous coronary interventions. Remote ischemic preconditioning is proved to protect myocardium in patients undergoing percutaneous coronary angiography. We will evaluate the effect of remote preconditioning on renal protection.

Official Title
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Renal PRotection Against Contrast mEdium-induced nephroPathy in High Risk Patients undErgoing Coronary Angiography

Conditions
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Renal Insufficiency, Contrast Medium-induced Renal Insufficiency

Intervention / Treatment
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* Procedure: Coronary Angiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient headed to coronary angiography Glomerular filtration rate : ≤ 40ml/min/1,73m² (MDRD equation) or ≤ 60ml/min/1,73m² (MDRD equation) with 1 additional risk factor : age > 75 years, NYHA ≥ III/IV, diabetes mellitus Signed informed consent Exclusion Criteria: Preoperative assessment / dilated cardiomyopathy assessment Acute ST-segment elevation myocardial infarction Cardiogenic shock requiring pressor amine or systolic blood pressure <80mmHg Resuscitation after cardiac arrest Intra-aortic balloon pump Contraindication for the repeted use of an upper-arm pressure cuff Extra-renal epuration No health insurance coverage Legal incapacity (patients under tutorship, curatorship or judicial protection) Patient enrolled in another interventional trial or being in a washout period Incapacity/impossibility to undergo 12-month follow-up Patient refusal

Ages Eligible for Study
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Minimum Age: 19 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remote Ischemic Preconditioning<br>A blood pressure cuff is placed on upper arm and inflated to 200 mmHg for 5 minutes and then deflated for 5 minutes. This cycle is repeated 3 times in total. The procedure has to be completed between 5 and 60 minutes prior coronary angiography. | Procedure: Coronary Angiography<br>* Coronary angiography is performed following usual site standards<br>|
| Sham Comparator: Control<br>A blood pressure cuff is placed on upper arm and inflated to 10 mmHg for 5 minutes and then deflated for 5 minutes. This cycle is repeated 3 times in total. The procedure has to be completed between 5 and 60 minutes prior coronary angiography. | Procedure: Coronary Angiography<br>* Coronary angiography is performed following usual site standards<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in serum creatinin level (≥25% or 0,5mg/dL) | Serum creatinin level is measured 48h after coronary angiography to assess contrast medium-induced nephropathy | 48h after coronary angiography | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum creatinin level is measured 12 months after coronary angiography and major adverse events are collected to assess long-term effects of remote ischemic preconditioning on renal function |  | 12 months after coronary angiography |