Remote Ischemic Conditioning Using the autoRIC

Last updated: August 28, 2018
Sponsor: CellAegis US, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Organ Transplant

Occlusions

Treatment

N/A

Clinical Study ID

NCT03318575
CS-000002 2013-SHIELD
  • Ages > 18
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject is ≥ 18 years of age

  2. Subject is scheduled for elective PCI, or unscheduled but non-emergent PCI, ordiagnostic catheterization with PCI if indicated. For non-elective cases, there mustbe at least two troponin levels within the upper limit of normal (ULN), at least 6hours 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 negativepregnancy test within 24 hours of the study procedure

Exclusion

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 labresults 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 indexhospitalization or within 4 weeks post-procedure

  11. Subject has either serum creatinine >2 times the age-appropriate upper limit ofnormal, 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 limbto be treated

  15. Subject has peripheral nerve injury, abnormal nerve supply, peripheral neuropathy orpre-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 anotherinvestigational 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 ofnon-target lesions in any vessel or CABG). (Note: Planned revascularization (PCI orbypass) 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 Design

Total Participants: 500
Study Start date:
January 30, 2018
Estimated Completion Date:
April 30, 2019

Study 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.

Connect with a study center

  • William Osler Health System

    Brampton, Ontario L6R 3J7
    Canada

    Active - Recruiting

  • St. Michael's Hospital

    Toronto, Ontario M5B 1W8
    Canada

    Active - Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Active - Recruiting

  • Danbury Hospital

    Danbury, Connecticut 06810
    United States

    Active - Recruiting

  • University of Florida Health Jacksonville

    Jacksonville, Florida 32209
    United States

    Active - Recruiting

  • Iowa Heart Center

    Des Moines, Iowa 50314
    United States

    Active - Recruiting

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Henry Ford West Bloomfield Hospital

    West Bloomfield, Michigan 48322
    United States

    Active - Recruiting

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri 64111
    United States

    Active - Recruiting

  • Southside Hospital

    Bay Shore, New York 11706
    United States

    Active - Recruiting

  • North Shore University Hospital

    Manhasset, New York 11030
    United States

    Active - Recruiting

  • Lenox Hill Hospital

    New York, New York 10075
    United States

    Active - Recruiting

  • Mount Sinai Hospital

    New York, New York 10029
    United States

    Active - Recruiting

  • Staten Island University Hospital

    Staten Island, New York 10305
    United States

    Active - Recruiting

  • Novant Health Heart and Vascular Institute

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • NC Heart and Vascular Research

    Raleigh, North Carolina 27607
    United States

    Active - Recruiting

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