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Remote Ischemic Preconditioning in ACS Patients

NCT ID: NCT03329612

Last Updated: 2022-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-26

Study Completion Date

2018-12-30

Brief Summary

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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

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Conditions

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Acute Coronary Syndrome Renal Insufficiency Ischemia, Myocardial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Remote Ischemic Preconditioning

Intervention Type PROCEDURE

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

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.

Group Type SHAM_COMPARATOR

Remote Ischemic Preconditioning

Intervention Type PROCEDURE

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

Interventions

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Remote Ischemic Preconditioning

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henry Ford Health System

OTHER

Sponsor Role lead

Responsible Party

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Brittany Fuller, MD

Co-Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gerald Koenig, MD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Health System

Locations

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Henry Ford Hospital

Detroit, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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RIPC in ACS

Identifier Type: -

Identifier Source: org_study_id