Remote Ischemic Preconditioning in ACS Patients

Henry Ford Health System

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Conditions

Acute Coronary Syndrome Renal Insufficiency Ischemia, Myocardial

Interventions

Remote Ischemic PreconditioningPROCEDURE

Serial inflations and deflations as detailed in the arm/group descriptions.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Henry Ford Hospital

Detroit, Michigan, United States

Outcomes

Primary Outcomes

Ischemic Burden

Assess the impact of remote ischemic preconditioning on myonecrosis following percutaneous coronary intervention by examining pre and post biomarkers

Time frame: 48-72 hours

Secondary Outcomes

Clinical Outcomes

Assess the effects on clinical outcomes at 6 months post initial ACS event including death, MI, stroke, revascularization and hospital readmission.

Time frame: 6 months

Renal Injury

Assess the effects on post procedure renal injury

Time frame: 48-72 hours

Data from ClinicalTrials.gov

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