Efficacy of RIPC to Reduce AKI for Patients Undergoing PCI

Study Overview
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Brief Summary
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The purpose of the present study is to determine if remote ischemic preconditioning reduces incidence of acute kidney injury in patients with reduced kidney function undergoing Percutaneous Coronary Intervention.

Detailed Description
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Acute kidney injury negatively impacts on prognosis after PCI, and only hydratation have shown to reduce this complication. Remote ischemic preconditioning has been demonstrated to reduce periprocedural MI, while impact on aki remains to be assessed

Official Title
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The EUROpean and Asian Cardiac and Renal Remote Ischemic Pre-conditioning Study : A Prospective, Randomized Control Trial

Conditions
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Acute Kidney Injury

Intervention / Treatment
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* Procedure: Remote ischemic preconditioning
* Procedure: Sham remote ischemic preconditioning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: undergoing PCI with stenting for all clinical indications carrying (with) a renal clearance less than 60 mL/min/1.73 m2 and more than 30 mL/min/1.73 m2 (evaluated through MDRD); ù younger than 85 years old. Exclusion Criteria: ST Segment Elevation Myocardial Infarction (STEMI), unstable hemodynamic presentations (cardiogenic shock) or ongoing severe arrhythmias;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham remote ischemic preconditioning'<br>In the control group Sham remote ischemic preconditioning will be performed with inflation of 10 mmHg more than baseline | Procedure: Sham remote ischemic preconditioning<br>* In the control group sham preconditioning will be performed with inflation of 10 mmHg more than baseline.<br>|
| Experimental: Remote ischemic preconditioning<br>In the experimental group, patients will receive for four times 5-minute inflations of a blood pressure cuff to 200 mmHg around the upper non dominant arm (or if systolic pressure is more than 150 mmHg, inflation will reach 50 mmHg upper than baseline), followed by 5-minute intervals of reperfusion. In subjects presenting with BMI > 30 a dedicated blood pressure cuff for obese patients will be used. Coronary angiography will be performed in 45 minutes from last inflation | Procedure: Remote ischemic preconditioning<br>* four times 5-minute inflations of a blood pressure cuff to 200 mmHg around the upper non dominant arm (or if systolic pressure is more than 150 mmHg, inflation will reach 50 mmHg up per than baseline), followed by 5-minute intervals of reperfusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of acute kidney injury | Acute Kidney Injury defined as Acute kidney injury is defined as an increase serum creatinine greater than 0.5 mg/dL, or by a relative increase of at least 25% over the baseline value within a period of 48-hours after contrast medium administration | 24 and 48 hours after PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of periprocedural myocardial infarction |  | 24 and 48 hours after PCI |