Biochemical Effects of Remote Ischemic Pre-Conditioning on Contrast-induced Acute Kidney Injury

Study Overview
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Brief Summary
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This a prospective, double-blind, sham-controlled, randomized clinical trial to study the effects of remote ischemic preconditioning on contrast-induced acute kidney injury, vascular and renal biomarkers in patients with non-ST elevation myocardial infarction and unstable angina undergoing cardiac catheterization and percutaneous coronary intervention.

Detailed Description
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The BRICK study is a prospective, double-blind, sham-controlled, randomized clinical trial in patients with non-ST elevation myocardial infarction and unstable angina undergoing cardiac catheterization and percutaneous coronary intervention who are at high risk for contrast-induced acute kidney injury. The study will investigate the effects of remote ischemic preconditioning before cardiac catheterization on rate of contrast induced acute kidney injury and novel biomarkers of renal injury/protection within 48hrs of cardiac catheterization.

Official Title
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Biochemical and Reno-protective Effects of Remote Ischemic Pre-conditioning on Contrast-induced Acute Kidney Injury

Conditions
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Contrast-induced Acute Kidney Injury

Intervention / Treatment
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* Device: RIPC
* Device: Sham-RIPC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with non-ST elevation myocardial infarction or unstable angina Referral for cardiac catheterization and percutaneous coronary intervention Contrast-induced acute kidney injury risk score of ≥11 Exclusion Criteria: Inability to give informed consent unstable blood pressure (systolic blood pressure > 200 or <90 mmHg) History of allergy to contrast media Peripheral vascular disease of upper limb Renal disease requiring dialysis Placement of arteriovenous fistula and arteriovenous graft

Ages Eligible for Study
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Minimum Age: 18 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RIPC Group<br>3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes | Device: RIPC<br>* Remote ischemic preconditioning<br>|
| Sham Comparator: Sham-RIPC Group<br>3 cycles of blood pressure cuff inflations to non-occlusive pressure of 10 mmHg for 5 minutes and deflation for 5 minutes (Control) | Device: Sham-RIPC<br>* Control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contrast-induced acute kidney injury | Contrast-induced acute kidney injury is defined as a relative increase in serum creatinine of ≥ 0.3mg/dl at 48 hours post catheterization compared with initial creatinine before catheterization. | 24-48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers study | Novel vascular and renal biomarkers | 0-48 hours | 
| Major Adverse Cardiovascular Event |  | 1 month and 6 months | 
| Major Adverse Kidney Event |  | 1 month and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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remote ischemic conditioning, contrast-induced nephropathy, cardiac catheterization, coronary artery disease