Status:
UNKNOWN
Remote Ischemic Conditioning Using the autoRIC
Lead Sponsor:
CellAegis US, Inc.
Conditions:
Ischemia-Reperfusion Injury
Eligibility:
All Genders
18+ years
Phase:
NA
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 ische...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Subject is scheduled for a PCI procedure to treat a known Chronic Total Occlusion (CTO) lesion
- 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.)
- 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.)
- Any cardiac surgical procedure planned within 30 days post-enrollment
Key Trial Info
Start Date :
January 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2019
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT03318575
Start Date
January 30 2018
End Date
April 1 2019
Last Update
August 31 2018
Active Locations (16)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Danbury Hospital
Danbury, Connecticut, United States, 06810
3
University of Florida Health Jacksonville
Jacksonville, Florida, United States, 32209
4
Iowa Heart Center
Des Moines, Iowa, United States, 50314