Remote Ischemic Preconditioning in ACS Patients

NCT03329612 | Withdrawn

• 1 other identifier: RIPC in ACS
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome; Renal Insufficiency; Ischemia, Myocardial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Clinical Outcomes

  6 months

• Renal Injury

  48-72 hours

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

SHAM COMPARATOR

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

Remote Ischemic Preconditioning PROCEDURE

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

Control; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; Renal Insufficiency; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Gerald Koenig, MD

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Investigator

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: November 6, 2017
• Study Start: October 26, 2016
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2018
• Last Updated: December 14, 2022

Record last verified: 2022-12

Locations

US (1)