Remote Ischemic Preconditioning in ACS Patients

Acute Coronary Syndrome Clinical Trial

Official title:

Remote Ischemic Preconditioning in ACS Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03329612
• Other study ID #: RIPC in ACS
• Status: Withdrawn
• Phase: N/A
• Start date: October 26, 2016
• Est. completion date: December 30, 2018

Study information

• Verified date: December 2022
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 30, 2018
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Ischemia
• Ischemia, Myocardial
• Myocardial Ischemia
• Renal Insufficiency

Intervention

Procedure:
• Remote Ischemic Preconditioning
Serial inflations and deflations as detailed in the arm/group descriptions.

Locations

Country	Name	City	State
United States	Henry Ford Hospital	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Renal Injury	Assess the effects on post procedure renal injury	48-72 hours