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Remote Ischemic Conditioning Using the autoRIC (SHIELD)

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ClinicalTrials.gov Identifier: NCT03318575
Recruitment Status : Recruiting
First Posted : October 24, 2017
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
CellAegis US, Inc.

Brief 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).

Condition or disease Intervention/treatment Phase
Ischemia-Reperfusion Injury Device: autoRIC Device: autoRIC Sham Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Safety and Effectiveness of Remote Ischemic Conditioning With the autoRIC Prior to Elective Percutaneous Coronary Intervention (PCI) Study
Actual Study Start Date : January 30, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

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




Primary Outcome Measures :
  1. (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.

  2. (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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03318575


Contacts
Contact: Vera Belaoussoff 647-722-9601 ext 105 vbelaoussoff@cellaegisdevices.com
Contact: Brad Solberg 408-400-0856 brad@experiengroup.com

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Patrick Frazier, RN    205-934-5774    CCTU@uabmc.edu   
Principal Investigator: Massoud Leesar, MD         
United States, Connecticut
Danbury Hospital Recruiting
Danbury, Connecticut, United States, 06810
Contact: Monica Tawadros, MPH    203-739-7134    Monica.Tawadros@wchn.org   
Principal Investigator: Hal Wasserman, MD         
United States, Florida
University of Florida Health Jacksonville Recruiting
Jacksonville, Florida, United States, 32209
Contact: Emily Green, BSN, RN    904-244-2794    emily.green@jax.ufl.edu   
Principal Investigator: Andres Pineda Maldonado, MD         
United States, Iowa
Iowa Heart Center Recruiting
Des Moines, Iowa, United States, 50314
Contact: Kassandra Seitz, BSN, RN    515-235-5114    kseitz@iowaheart.com   
Principal Investigator: Magdi Ghali, MD         
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Margaret Fox, RN, BSN    313-916-1879    mfox2@hfhs.org   
Principal Investigator: Gerald Koenig, MD, PhD         
Henry Ford West Bloomfield Hospital Recruiting
West Bloomfield, Michigan, United States, 48322
Contact: Mishel Tabaku    248-325-0737    Mtabaku1@hfhs.org   
Principal Investigator: Gerald Koenig, MD, PhD         
United States, Missouri
Saint Luke's Hospital of Kansas City Recruiting
Kansas City, Missouri, United States, 64111
Contact: Lisa Lacy, RCIS    816-932-7528    lnewhouse@saint-lukes.org   
Principal Investigator: John Saxon, MD         
United States, New York
Southside Hospital Recruiting
Bay Shore, New York, United States, 11706
Contact: Barbara Shannon, RN, BSN    631-968-3016    bshannon@northwell.edu   
Principal Investigator: Cindy Grines, MD         
North Shore University Hospital Recruiting
Manhasset, New York, United States, 11030
Contact: Ruby Garzon, RN, MSN    516-562-4168    rgrazon@northwell.edu   
Principal Investigator: Cindy Grines, MD         
Mount Sinai Hospital Recruiting
New York, New York, United States, 10029
Contact: Nicole Saint Vrestil, BA    212-241-9687    nicole.saintvrestil@mountsinai.org   
Principal Investigator: Joseph Sweeney, MD         
Lenox Hill Hospital Recruiting
New York, New York, United States, 10075
Contact: Priscilla Chu, BA    212-434-3362    Pchu3@northwell.edu   
Principal Investigator: Cindy Grines, MD         
Staten Island University Hospital Recruiting
Staten Island, New York, United States, 10305
Contact: Richie Dima, MD    718-226-1489    rdima@northwell.edu   
Principal Investigator: Cindy Grines, MD         
United States, North Carolina
Novant Health Heart and Vascular Institute Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Pailing Richards, RN, BSN    704-264-1400    pcrichards@novanthealth.org   
Principal Investigator: Amjad Almahameed, MD         
NC Heart and Vascular Research Recruiting
Raleigh, North Carolina, United States, 27607
Contact: James R Pierre-Louis, MD, CRS    919-784-7695    james.pierre-louis@unchealth.unc.edu   
Principal Investigator: Mohit Pasi, MD         
Canada, Ontario
William Osler Health System Recruiting
Brampton, Ontario, Canada, L6R 3J7
Contact: James Kemp, BS    905-494-2120 ext 58666    James.kemp@williamoslerhs.ca   
Principal Investigator: Shy Amlani, MD         
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Ivana Kandic, MSc.    416-864-6060 ext 6120    kandici@smh.ca   
Principal Investigator: Akshay Bagai, MD         
Sponsors and Collaborators
CellAegis US, Inc.
Investigators
Principal Investigator: Roxana Mehran, MD Cardiovascular Medicine Associates

Responsible Party: CellAegis US, Inc.
ClinicalTrials.gov Identifier: NCT03318575     History of Changes
Other Study ID Numbers: CS-000002 2013-SHIELD
First Posted: October 24, 2017    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by CellAegis US, Inc.:
remote ischemic conditioning (RIC)
percutaneous coronary intervention
PCI
cardiac troponin I
cardiac catheterization
myocardial injury
myocardial necrosis
autoRIC
Ischemia-Reperfusion Injury (IRI)
Automated Remote Ischemic Conditioning

Additional relevant MeSH terms:
Ischemia
Reperfusion Injury
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications