Remote Ischemic Conditioning Using the autoRIC (SHIELD)

CellAegis US

Status: Unknown

Conditions: Ischemia-Reperfusion Injury

Treatments: Device: autoRIC; Device: autoRIC Sham

Study type: Interventional

Funder types: Industry

Identifiers

NCT03318575

CS-000002 2013-SHIELD

Details and patient eligibility

About

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).

Full 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 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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500 participants in 2 patient groups

autoRIC

Experimental group

Description:

The autoRIC device will be used on subjects randomized to the treatment group.

Treatment:

Device: autoRIC

autoRIC Sham

Sham Comparator group

Description:

The autoRIC Sham device will be used on subjects randomized to the control group.

Treatment:

Device: autoRIC Sham