Remote Ischemic Preconditioning in ACS Patients

Henry Ford Health

Status: Withdrawn

Conditions: Acute Coronary Syndrome; Ischemia, Myocardial; Renal Insufficiency

Treatments: Procedure: Remote Ischemic Preconditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT03329612

RIPC in ACS

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Procedure: Remote Ischemic Preconditioning

Control

Sham Comparator group

Description:

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.

Treatment:

Procedure: Remote Ischemic Preconditioning