Remote Ischemic Preconditioning in ACS Patients

Not Applicable

Withdrawn

• Conditions: Acute Coronary Syndrome; Renal Insufficiency; Ischemia, Myocardial
• Interventions: Procedure: Remote Ischemic Preconditioning

• Registration Number: NCT03329612
• Lead Sponsor: Henry Ford Health System

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-26
• Study First Submitted: 2017-10-30
• Study First Submitted QC: 2017-10-30
• Study First Posted: 2017-11-06
• Primary Completion: 2018-12-30
• Study Completion: 2018-12-30
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-12
• Last Update Posted: 2022-12-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Remote Ischemic Preconditioning	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.
Intervention	Remote Ischemic Preconditioning	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States