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Remote Ischemic Preconditioning in ACS Patients

Sponsor
Henry Ford Health System (Other)
Overall Status
Unknown status
CT.gov ID
NCT03329612
Collaborator
(none)
250
Enrollment
1
Location
2
Arms
34.1
Anticipated Duration (Months)
7.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Remote Ischemic Preconditioning
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Remote Ischemic Preconditioning in ACS Patients
Actual Study Start Date :
Oct 26, 2016
Anticipated Primary Completion Date :
Oct 30, 2018
Anticipated Study Completion Date :
Aug 30, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Ischemic Burden [48-72 hours]

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

Secondary Outcome Measures

  1. Clinical Outcomes [6 months]

    Assess the effects on clinical outcomes at 6 months post initial ACS event including death, MI, stroke, revascularization and hospital readmission.

  2. Renal Injury [48-72 hours]

    Assess the effects on post procedure renal injury

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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:

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Henry Ford Hospital Detroit Michigan United States 48202

Sponsors and Collaborators

  • Henry Ford Health System

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Brittany Fuller, MD, Co-Investigator, Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT03329612
Other Study ID Numbers:
  • RIPC in ACS
First Posted:
Nov 6, 2017
Last Update Posted:
Aug 1, 2018
Last Verified:
Jul 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Renal Insufficiency
Acute Coronary Syndrome
Myocardial Ischemia
Ischemia

Study Results

No Results Posted as of Aug 1, 2018