CClinicalTrials.gg
WithdrawnNCT03329612Updated Dec 14, 2022

Remote Ischemic Preconditioning in ACS Patients

An interventional study of Remote Ischemic Preconditioning in Acute Coronary Syndrome, Renal Insufficiency and Ischemia, Myocardial, sponsored by Henry Ford Health System. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-14.

Sponsored by Henry Ford Health System · Not applicable, Interventional, and Prevention

Why this study was withdrawn
poor enrollment
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Coronary Syndrome
  • Renal Insufficiency
  • Ischemia, Myocardial
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
0 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • ProcedureRemote Ischemic Preconditioning

    Serial inflations and deflations as detailed in the arm/group descriptions.

05

What researchers measure

Primary outcomes

  1. Ischemic Burden

    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 outcomes

  1. Clinical Outcomes

    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

  2. Renal Injury

    Assess the effects on post procedure renal injury

    Time frame: 48-72 hours

06

Study locations

1 site
  • Henry Ford Hospital
    Detroit, Michigan 48202, United States
07

Registry details

Key details

Study ID
NCT03329612
Lead sponsor
Henry Ford Health System
Responsible party
Brittany Fuller, MD (Co-Investigator, Henry Ford Health System) — Principal investigator
First posted
Nov 6, 2017
Start date
Oct 26, 2016
Primary completion
Dec 30, 2018
Completion
Dec 30, 2018
Last update
Dec 14, 2022

Study contacts

Gerald Koenig, MD
principal investigator · Henry Ford Health System

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion