Remote Ischemic Conditioning Using the autoRIC (SHIELD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03318575
Recruitment Status : Recruiting
First Posted : October 24, 2017
Last Update Posted : July 17, 2018
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-elective PCI procedure).

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 elective PCI.

Eligible patients that are scheduled for an elective 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 : November 2018
Estimated Study Completion Date : November 2018

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 at or 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  1. Subject is ≥ 18 years of age
  2. Subject has documented evidence of ischemia (e.g. ECG changes with evidence of ischemia, positive stress test and/or non-invasive imaging study) and is scheduled for elective PCI, or diagnostic catheterization with PCI if indicated; in accordance with the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention
  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
  2. Subject has detectable troponin level at baseline or any known troponin elevation within 7 days prior to baseline
  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 MI, coronary artery bypass graft (CABG) or previous PCI during the last 4 weeks prior to baseline
  6. Subject has a life expectancy < 6 months
  7. Subject has heart failure (NYHA Class III or IV)
  8. Subject has peripheral vascular disease requiring intervention during the index hospitalization or within 4 weeks post-procedure
  9. 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
  10. Subject has systolic blood pressure > 200 mmHg
  11. Subject is currently being treated with systemic oral or I.V. steroids
  12. Subject has a known bleeding disorder or known abnormality of blood flow to the limb to be treated
  13. Subject has peripheral nerve injury, abnormal nerve supply, peripheral neuropathy or pre-existing traumatic injury to the limb to be treated
  14. Subject is scheduled for an elective PCI procedure to treat a known Chronic Total Occlusion (CTO) lesion
  15. Subject is currently participating in or is planning to participate in an investigational drug or device trial, including Registries, prior to the 30-day follow-up visit

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 identifier (NCT number): NCT03318575

Contact: Vera Belaoussoff 647-722-9601 ext 105
Contact: Brad Solberg 408-400-0856

United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Patrick Frazier, RN    205-934-5774   
Principal Investigator: Massoud Leesar, MD         
United States, Florida
University of Florida Health Jacksonville Recruiting
Jacksonville, Florida, United States, 32209
Contact: Emily Green, BSN, RN    904-244-2794   
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   
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   
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   
Principal Investigator: John Saxon, 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   
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   
Principal Investigator: Mohit Pasi, MD         
Sponsors and Collaborators
CellAegis US, Inc.
Principal Investigator: Roxana Mehran, MD Cardiovascular Medicine Associates

Responsible Party: CellAegis US, Inc. Identifier: NCT03318575     History of Changes
Other Study ID Numbers: CS-000002 2013-SHIELD
First Posted: October 24, 2017    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 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
cardiac troponin I
cardiac catheterization
myocardial injury
myocardial necrosis
Ischemia-Reperfusion Injury (IRI)
Automated Remote Ischemic Conditioning

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