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Remote Ischemic Preconditioning in ACS Patients

Primary Purpose

Acute Coronary Syndrome, Renal Insufficiency, Ischemia, Myocardial

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Remote Ischemic Preconditioning
Sponsored by
Henry Ford Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Coronary Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Henry Ford Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Intervention

Control

Arm 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.

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.

Outcomes

Primary Outcome Measures

Ischemic Burden
Assess the impact of remote ischemic preconditioning on myonecrosis following percutaneous coronary intervention by examining pre and post biomarkers

Secondary Outcome Measures

Clinical Outcomes
Assess the effects on clinical outcomes at 6 months post initial ACS event including death, MI, stroke, revascularization and hospital readmission.
Renal Injury
Assess the effects on post procedure renal injury

Full Information

First Posted
October 30, 2017
Last Updated
December 12, 2022
Sponsor
Henry Ford Health System
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1. Study Identification

Unique Protocol Identification Number
NCT03329612
Brief Title
Remote Ischemic Preconditioning in ACS Patients
Official Title
Remote Ischemic Preconditioning in ACS Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Withdrawn
Why Stopped
poor enrollment
Study Start Date
October 26, 2016 (Actual)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Renal Insufficiency, Ischemia, Myocardial

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Remote Ischemic Preconditioning
Intervention Description
Serial inflations and deflations as detailed in the arm/group descriptions.
Primary Outcome Measure Information:
Title
Ischemic Burden
Description
Assess the impact of remote ischemic preconditioning on myonecrosis following percutaneous coronary intervention by examining pre and post biomarkers
Time Frame
48-72 hours
Secondary Outcome Measure Information:
Title
Clinical Outcomes
Description
Assess the effects on clinical outcomes at 6 months post initial ACS event including death, MI, stroke, revascularization and hospital readmission.
Time Frame
6 months
Title
Renal Injury
Description
Assess the effects on post procedure renal injury
Time Frame
48-72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerald Koenig, MD
Organizational Affiliation
Henry Ford Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States

12. IPD Sharing Statement

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Remote Ischemic Preconditioning in ACS Patients

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