Remote Ischemic Conditioning Using the autoRIC (SHIELD)

August 28, 2018 updated by: CellAegis US, Inc.

Safety and Effectiveness of Remote Ischemic Conditioning With the autoRIC Prior to Elective Percutaneous Coronary Intervention (PCI) Study

The purpose of the study is to evaluate the hypothesis that patients receiving remote ischemic conditioning using the autoRIC device show statistically significant reduction in the prevalence of ischemia-reperfusion injury to the myocardium as compared to patients in the autoRIC Sham device arm (within 12-24 hours post non-emergent PCI with stent implantation).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is a multi-center, randomized, controlled single-blind clinical trial to evaluate the safety and effectiveness of the autoRIC device to attenuate myocardial injury as measured by cardiac Troponin I (cTnI) levels in patients undergoing PCI with stent implantation.

Eligible patients that are scheduled for an elective PCI, or unscheduled/non-emergent PCI, or patients scheduled for a diagnostic catheterization procedure with orders of "treat as indicated" will be enrolled in the study. Patients will undergo remote ischemic conditioning with the autoRIC device or the control procedure with the autoRIC Sham device completed ≤ 1 hour prior to balloon or stent inflation. Subjects will have measurements of cTnI levels at baseline and 4-8 and 12-24 hours post completion of the PCI procedure. Adverse events will be recorded through study exit for all patients. Patients will be exited from the study after completion of their 30-day post-procedure telephone follow-up.

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Brampton, Ontario, Canada, L6R 3J7
        • Recruiting
        • William Osler Health System
        • Contact:
        • Principal Investigator:
          • Shy Amlani, MD
      • Toronto, Ontario, Canada, M5B 1W8
        • Recruiting
        • St. Michael's Hospital
        • Contact:
          • Ivana Kandic, MSc.
          • Phone Number: 6120 416-864-6060
          • Email: kandici@smh.ca
        • Principal Investigator:
          • Akshay Bagai, MD
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama at Birmingham
        • Contact:
          • Patrick Frazier, RN
          • Phone Number: 205-934-5774
          • Email: CCTU@uabmc.edu
        • Principal Investigator:
          • Massoud Leesar, MD
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Recruiting
        • Danbury Hospital
        • Contact:
        • Principal Investigator:
          • Hal Wasserman, MD
    • Florida
      • Jacksonville, Florida, United States, 32209
        • Recruiting
        • University of Florida Health Jacksonville
        • Contact:
        • Principal Investigator:
          • Andres Pineda Maldonado, MD
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Recruiting
        • Iowa Heart Center
        • Contact:
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
        • Contact:
          • Margaret Fox, RN, BSN
          • Phone Number: 313-916-1879
          • Email: mfox2@hfhs.org
        • Principal Investigator:
          • Gerald Koenig, MD, PhD
      • West Bloomfield, Michigan, United States, 48322
        • Recruiting
        • Henry Ford West Bloomfield Hospital
        • Principal Investigator:
          • Gerald Koenig, MD, PhD
        • Contact:
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • Saint Luke's Hospital of Kansas City
        • Contact:
        • Principal Investigator:
          • John Saxon, MD
    • New York
      • Bay Shore, New York, United States, 11706
        • Recruiting
        • Southside Hospital
        • Contact:
      • Manhasset, New York, United States, 11030
        • Recruiting
        • North Shore University Hospital
        • Contact:
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai Hospital
        • Contact:
        • Principal Investigator:
          • Joseph Sweeney, MD
      • New York, New York, United States, 10075
        • Recruiting
        • Lenox Hill Hospital
        • Contact:
      • Staten Island, New York, United States, 10305
        • Recruiting
        • Staten Island University Hospital
        • Contact:
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Novant Health Heart and Vascular Institute
        • Contact:
        • Principal Investigator:
          • Amjad Almahameed, MD
      • Raleigh, North Carolina, United States, 27607
        • Recruiting
        • NC Heart and Vascular Research
        • Contact:
        • Principal Investigator:
          • Mohit Pasi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject is ≥ 18 years of age
  2. Subject is scheduled for elective PCI, or unscheduled but non-emergent PCI, or diagnostic catheterization with PCI if indicated. For non-elective cases, there must be at least two troponin levels within the upper limit of normal (ULN), at least 6 hours apart prior to the index procedure
  3. Subject is willing and capable of providing written informed consent
  4. If the subject is a woman of childbearing potential, she must have had a negative pregnancy test within 24 hours of the study procedure

Exclusion Criteria:

  1. Subject requires emergency PCI (i.e., PCI for evolving or ongoing STEMI/NSTEMI)
  2. Subject has an elevated troponin level (cTnI or T) > ULN at baseline, based on lab results obtained from the treating institution
  3. Subject is scheduled to undergo PCI with the use of Propofol
  4. Subject has a recent history of drug treatment with potassium channel activators (e.g., Nicorandil) or potassium channel blockers (e.g., sulfonylureas) during the last 7 days prior to baseline
  5. Subject had STEMI during the last 4 weeks prior to baseline. (Note: NSTEMI in the last 4 weeks prior to baseline is allowed if the baseline troponin is ≤ ULN.)
  6. Underwent a CABG in the last 4 weeks prior to baseline
  7. Had a PCI within the last 7 days prior to baseline
  8. Subject has a life expectancy < 6 months
  9. Subject has NYHA Class IV or decompensated heart failure
  10. Subject has peripheral vascular disease requiring intervention during the index hospitalization or within 4 weeks post-procedure
  11. Subject has either serum creatinine >2 times the age-appropriate upper limit of normal, a glomerular filtration rate (GFR) of < 30 mL/min/1.73m2 or requires dialysis
  12. Subject has systolic blood pressure > 200 mmHg
  13. Subject is currently being treated with systemic oral or I.V. steroids
  14. Subject has a known bleeding disorder or known abnormality of blood flow to the limb to be treated
  15. Subject has peripheral nerve injury, abnormal nerve supply, peripheral neuropathy or pre-existing traumatic injury to the limb to be treated
  16. Subject is scheduled for a PCI procedure to treat a known Chronic Total Occlusion (CTO) lesion
  17. Subject is currently participating in or is planning to participate in another investigational drug or device trial, prior to the 30-day follow-up visit. (Note: Observational studies or post-approval studies/ registries, are allowed.)
  18. Planned (staged) post-index procedure intervention within 30 days (i.e., PCI of non-target lesions in any vessel or CABG). (Note: Planned revascularization (PCI or bypass) of a non-target lesion >30 days following the index procedure is allowed.)
  19. Any cardiac surgical procedure planned within 30 days post-enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: autoRIC
The autoRIC device will be used on subjects randomized to the treatment group.
Device: autoRIC
Automated Remote Ischemic Conditioning
SHAM_COMPARATOR: autoRIC Sham
The autoRIC Sham device will be used on subjects randomized to the control group.
Device: autoRIC Sham
Automated Remote Ischemic Conditioning Sham

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
(Primary Effectiveness) Attenuation of myocardial injury assessed by Cardiac Troponin I levels (cTnI)
Time Frame: 12-24 hours
The proportion of subjects with cTnI levels above the 99th percentile Upper Reference Limit (URL) (0.04 ng/mL) 12-24 hours post-PCI.
12-24 hours
(Primary Safety) Major Adverse Cardiac Events (MACE)
Time Frame: 30 days
The proportion of subjects with major adverse cardiac events (MACE) within 30 days. MACE is defined as: death, stroke, myocardial infarction or the need for target vessel revascularization.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type 4a Myocardial Infarction (MI)
Time Frame: 12-24 hours
The proportion of subjects with a Type 4a MI within 12-24 hours post- PCI.
12-24 hours
Contrast-Induced Acute Kidney Injury (CI-AKI)
Time Frame: 12-24 hours
The proportion of subjects with CI-AKI defined as > 25% or 0.5 mg/dl increase in serum creatinine above baseline within 12-24 hours post-PCI.
12-24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CellAegis US, Inc.

Investigators

  • Principal Investigator: Roxana Mehran, MD, Cardiovascular Medicine Associates

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 30, 2018

Primary Completion (ANTICIPATED)

April 1, 2019

Study Completion (ANTICIPATED)

April 1, 2019

Study Registration Dates

First Submitted

October 19, 2017

First Submitted That Met QC Criteria

October 19, 2017

First Posted (ACTUAL)

October 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 31, 2018

Last Update Submitted That Met QC Criteria

August 28, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS-000002 2013-SHIELD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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