Remote Ischemic Conditioning Using the autoRIC

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Ischemia-Reperfusion Injury

In brief

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).

Key facts

Study ID

NCT03318575

Run by

CellAegis US, Inc.

People needed

500

Starts

2018-01-30

Expected to finish

2019-04-01

Last updated by the study team

2018-08-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
• Danbury Hospital — Danbury, Connecticut, United States (enrolling)
• University of Florida Health Jacksonville — Jacksonville, Florida, United States (enrolling)
• Iowa Heart Center — Des Moines, Iowa, United States (enrolling)
• Henry Ford Hospital — Detroit, Michigan, United States (enrolling)
• Henry Ford West Bloomfield Hospital — West Bloomfield, Michigan, United States (enrolling)
• Saint Luke's Hospital of Kansas City — Kansas City, Missouri, United States (enrolling)
• Southside Hospital — Bay Shore, New York, United States (enrolling)
• North Shore University Hospital — Manhasset, New York, United States (enrolling)
• Mount Sinai Hospital — New York, New York, United States (enrolling)
• Lenox Hill Hospital — New York, New York, United States (enrolling)
• Staten Island University Hospital — Staten Island, New York, United States (enrolling)
• Novant Health Heart and Vascular Institute — Charlotte, North Carolina, United States (enrolling)
• NC Heart and Vascular Research — Raleigh, North Carolina, United States (enrolling)
• William Osler Health System — Brampton, Ontario, Canada (enrolling)
• St. Michael's Hospital — Toronto, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.