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).
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
500
Automated Remote Ischemic Conditioning
Automated Remote Ischemic Conditioning Sham
University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGDanbury Hospital
(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.
Time frame: 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.
Time frame: 30 days
Type 4a Myocardial Infarction (MI)
The proportion of subjects with a Type 4a MI within 12-24 hours post- PCI.
Time frame: 12-24 hours
Contrast-Induced Acute Kidney Injury (CI-AKI)
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.
Time frame: 12-24 hours
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Danbury, Connecticut, United States
University of Florida Health Jacksonville
Jacksonville, Florida, United States
RECRUITINGIowa Heart Center
Des Moines, Iowa, United States
RECRUITINGHenry Ford Hospital
Detroit, Michigan, United States
RECRUITINGHenry Ford West Bloomfield Hospital
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Kansas City, Missouri, United States
RECRUITINGSouthside Hospital
Bay Shore, New York, United States
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RECRUITING...and 6 more locations