Ischemia-Reperfusion Injury Clinical Trial
Official title:
Safety and Effectiveness of Remote Ischemic Conditioning With the autoRIC Prior to Elective Percutaneous Coronary Intervention (PCI) Study
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.
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