Remote Ischemic Preconditioning in ACS Patients

December 12, 2022 updated by: Brittany Fuller, MD, Henry Ford Health System
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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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.
Procedure: Remote Ischemic Preconditioning
Serial inflations and deflations as detailed in the arm/group descriptions.
Sham Comparator: Control
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.
Procedure: Remote Ischemic Preconditioning
Serial inflations and deflations as detailed in the arm/group descriptions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ischemic Burden
Time Frame: 48-72 hours
Assess the impact of remote ischemic preconditioning on myonecrosis following percutaneous coronary intervention by examining pre and post biomarkers
48-72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Outcomes
Time Frame: 6 months
Assess the effects on clinical outcomes at 6 months post initial ACS event including death, MI, stroke, revascularization and hospital readmission.
6 months
Renal Injury
Time Frame: 48-72 hours
Assess the effects on post procedure renal injury
48-72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry Ford Health System

Investigators

  • Principal Investigator: Gerald Koenig, MD, Henry Ford Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2016

Primary Completion (Actual)

December 30, 2018

Study Completion (Actual)

December 30, 2018

Study Registration Dates

First Submitted

October 30, 2017

First Submitted That Met QC Criteria

October 30, 2017

First Posted (Actual)

November 6, 2017

Study Record Updates

Last Update Posted (Estimate)

December 14, 2022

Last Update Submitted That Met QC Criteria

December 12, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIPC in ACS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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