Acute Coronary Syndrome, Ischemia, Myocardial, Renal Insufficiency
Conditions
Brief summary
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.
Interventions
PROCEDURERemote Ischemic Preconditioning
Serial inflations and deflations as detailed in the arm/group descriptions.
Sponsors
Henry Ford Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ischemic Burden | 48-72 hours | Assess the impact of remote ischemic preconditioning on myonecrosis following percutaneous coronary intervention by examining pre and post biomarkers |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Outcomes | 6 months | Assess the effects on clinical outcomes at 6 months post initial ACS event including death, MI, stroke, revascularization and hospital readmission. |
| Renal Injury | 48-72 hours | Assess the effects on post procedure renal injury |
Countries
United States
Outcome results
None listed