Remote Ischemic Conditioning Using the autoRIC
SHIELD
Safety and Effectiveness of Remote Ischemic Conditioning With the autoRIC Prior to Elective Percutaneous Coronary Intervention (PCI) Study
1 other identifier
interventional
500
2 countries
16
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2018
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2017
CompletedFirst Posted
Study publicly available on registry
October 24, 2017
CompletedStudy Start
First participant enrolled
January 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedAugust 31, 2018
August 1, 2018
1.2 years
October 19, 2017
August 28, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
(Primary Effectiveness) Attenuation of myocardial injury assessed by Cardiac Troponin I levels (cTnI)
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)
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 Outcomes (2)
Type 4a Myocardial Infarction (MI)
12-24 hours
Contrast-Induced Acute Kidney Injury (CI-AKI)
12-24 hours
Study Arms (2)
autoRIC
EXPERIMENTALThe autoRIC device will be used on subjects randomized to the treatment group.
autoRIC Sham
SHAM COMPARATORThe autoRIC Sham device will be used on subjects randomized to the control group.
Interventions
Eligibility Criteria
You may qualify if:
- Subject is ≥ 18 years of age
- 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
- Subject is willing and capable of providing written informed consent
- If the subject is a woman of childbearing potential, she must have had a negative pregnancy test within 24 hours of the study procedure
You may not qualify if:
- Subject requires emergency PCI (i.e., PCI for evolving or ongoing STEMI/NSTEMI)
- Subject has an elevated troponin level (cTnI or T) \> ULN at baseline, based on lab results obtained from the treating institution
- Subject is scheduled to undergo PCI with the use of Propofol
- 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
- 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.)
- Underwent a CABG in the last 4 weeks prior to baseline
- Had a PCI within the last 7 days prior to baseline
- Subject has a life expectancy \< 6 months
- Subject has NYHA Class IV or decompensated heart failure
- Subject has peripheral vascular disease requiring intervention during the index hospitalization or within 4 weeks post-procedure
- 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
- Subject has systolic blood pressure \> 200 mmHg
- Subject is currently being treated with systemic oral or I.V. steroids
- Subject has a known bleeding disorder or known abnormality of blood flow to the limb to be treated
- Subject has peripheral nerve injury, abnormal nerve supply, peripheral neuropathy or pre-existing traumatic injury to the limb to be treated
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Danbury Hospital
Danbury, Connecticut, 06810, United States
University of Florida Health Jacksonville
Jacksonville, Florida, 32209, United States
Iowa Heart Center
Des Moines, Iowa, 50314, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
Southside Hospital
Bay Shore, New York, 11706, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Mount Sinai Hospital
New York, New York, 10029, United States
Lenox Hill Hospital
New York, New York, 10075, United States
Staten Island University Hospital
Staten Island, New York, 10305, United States
Novant Health Heart and Vascular Institute
Charlotte, North Carolina, 28204, United States
NC Heart and Vascular Research
Raleigh, North Carolina, 27607, United States
William Osler Health System
Brampton, Ontario, L6R 3J7, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roxana Mehran, MD
Cardiovascular Medicine Associates
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2017
First Posted
October 24, 2017
Study Start
January 30, 2018
Primary Completion
April 1, 2019
Study Completion
April 1, 2019
Last Updated
August 31, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share