Remote Ischemic Preconditioning in ACS Patients

Study Overview
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Brief Summary
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Remote ischemic preconditioning is a process of serial blood pressure cuff inflations and deflations that are performed prior to a procedure and have been shown in various other areas (coronary bypass surgery, vascular surgery, ST elevation myocardial infarctions) to decrease the rates of adverse events related to ischemic burden and renal injury. This procedure has not yet been studied in the population presenting with an acute coronary syndrome (ACS), even though ACS patients represent the majority of patients seen in the catheterization lab. The purpose of this study is to evaluate the efficacy of this simple and safe procedure in this particular population.

Official Title
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Remote Ischemic Preconditioning in ACS Patients

Conditions
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Acute Coronary Syndrome, Renal Insufficiency, Ischemia, Myocardial

Intervention / Treatment
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* Procedure: Remote Ischemic Preconditioning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Presenting with an acute coronary syndrome including non-ST elevation myocardial infarction or unstable angina on optimal medical therapy with aspirin, P2Y12 inhibitors, unfractionated heparin, statin, +/- beta blocker, +/- ace inhibitor Exclusion Criteria: Presenting with ST elevation myocardial infarction Patients requiring circulatory support Need for emergent percutaneous coronary intervention Systemic hypotension (systolic blood pressure <90 mmHg) Patients in cardiogenic shock defined by requiring inotropes or vasopressors Patients currently on hemodialysis Presence of an arteriovenous dialysis fistula or graft or lymphedema in either arm Patients enrolled in other active cardiovascular investigational studies Severe comorbidities with a life expectancy of less than 6 months Pregnant or lactating women Patients unable to provide consent Patient taking the medication glibenclamide for treatment of diabetes

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>This group will undergo remote ischemic preconditioning with serial inflations of the blood pressure cuff to 200 mmHg followed by deflation for reperfusion for a period of 5 minutes each for a total of 4 cycles. | Procedure: Remote Ischemic Preconditioning<br>* Serial inflations and deflations as detailed in the arm/group descriptions.<br>|
| Sham Comparator: Control<br>This group will undergo serial inflations of the blood pressure cuff to 40 mmHg followed by deflation for a period of 5 minutes each for a total of 4 cycles. | Procedure: Remote Ischemic Preconditioning<br>* Serial inflations and deflations as detailed in the arm/group descriptions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ischemic Burden | Assess the impact of remote ischemic preconditioning on myonecrosis following percutaneous coronary intervention by examining pre and post biomarkers | 48-72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Outcomes | Assess the effects on clinical outcomes at 6 months post initial ACS event including death, MI, stroke, revascularization and hospital readmission. | 6 months | 
| Renal Injury | Assess the effects on post procedure renal injury | 48-72 hours |