Remote Ischemic Conditioning Using the autoRIC (SHIELD)

This is an interventional prevention trial for Ischemia-Reperfusion Injury focused on measuring 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 Read More

Inclusion Criteria:

1. Subject is ≥ 18 years of age
2. 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
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 (i.e., PCI for evolving or ongoing STEMI/NSTEMI)
2. Subject has an elevated troponin level (cTnI or T) > ULN at baseline, based on lab results obtained from the treating institution
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 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.)
6. Underwent a CABG in the last 4 weeks prior to baseline
7. Had a PCI within the last 7 days prior to baseline
8. Subject has a life expectancy < 6 months
9. Subject has NYHA Class IV or decompensated heart failure
10. Subject has peripheral vascular disease requiring intervention during the index hospitalization or within 4 weeks post-procedure
11. 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
12. Subject has systolic blood pressure > 200 mmHg
13. Subject is currently being treated with systemic oral or I.V. steroids
14. Subject has a known bleeding disorder or known abnormality of blood flow to the limb to be treated
15. Subject has peripheral nerve injury, abnormal nerve supply, peripheral neuropathy or pre-existing traumatic injury to the limb to be treated
16. Subject is scheduled for a PCI procedure to treat a known Chronic Total Occlusion (CTO) lesion
17. Subject is currently participating in or is planning to participate in another investigational drug or device trial, prior to the 30-day follow-up visit. (Note: Observational studies or post-approval studies/ registries, are allowed.)
18. Planned (staged) post-index procedure intervention within 30 days (i.e., PCI of non-target lesions in any vessel or CABG). (Note: Planned revascularization (PCI or bypass) of a non-target lesion >30 days following the index procedure is allowed.)
19. Any cardiac surgical procedure planned within 30 days post-enrollment