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Remote Ischemic Conditioning Using the autoRIC (SHIELD)

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ClinicalTrials.gov Identifier: NCT03318575
Recruitment Status : Not yet recruiting
First Posted : October 24, 2017
Last Update Posted : October 24, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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 14-18 hours post-elective PCI procedure).

Condition or disease Intervention/treatment
Ischemia-Reperfusion Injury Device: autoRIC Device: autoRIC Sham

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 14-18 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 Design

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
Anticipated Study Start Date : December 2017
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : June 2018
Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. (Primary Effectiveness) Attenuation of myocardial injury assessed by Cardiac Troponin I levels (cTnI) [ Time Frame: 14-18 hours ]
    The proportion of subjects with cTnI levels at or above the 99th percentile Upper Reference Limit (URL) (0.04 ng/mL) 14-18 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: 14-18 hours ]
    The proportion of subjects with a Type 4a MI within 14-18 hours post- PCI.

  2. Contrast-Induced Acute Kidney Injury (CI-AKI) [ Time Frame: 14-18 hours ]
    The proportion of subjects with CI-AKI defined as > 25% or 0.5 mg/dl increase in serum creatinine above baseline within 14-18 hours post-PCI.


Eligibility Criteria

Information from the National Library of Medicine

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

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 calcium channel blocker (including Nicorandil) or sulfonylurea 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 steroids
  12. Subject has a known bleeding disorder or known abnormality of blood flow to the limb to be treated (non-dominant arm)
  13. Subject has peripheral nerve injury, abnormal nerve supply, peripheral neuropathy or pre-existing traumatic injury to the limb to be treated (non-dominant arm)
Contacts and Locations

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

Sponsors and Collaborators
CellAegis US, Inc.
Investigators
Principal Investigator: Roxana Mehran, MD Cardiovascular Medicine Associates
More Information

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: October 24, 2017
Last Verified: October 2017
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