Remote Ischemic Conditioning Using the autoRIC
(SHIELD Trial)
Recruiting in Palo Alto (17 mi)
+15 other locations
RM
Overseen byRoxana Mehran, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: CellAegis US, Inc.
No Placebo Group
Trial Summary
What is the purpose of this trial?
This trial tests if using a special device to temporarily stop blood flow to a limb can protect the heart in patients having a stent placed. It aims to see if this method reduces heart damage.
Research Team
RM
Roxana Mehran, MD
Principal Investigator
Cardiovascular Medicine Associates
Eligibility Criteria
Inclusion Criteria
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
See 1 more
Treatment Details
Interventions
- autoRIC (Ischemic Conditioning Device)
- autoRIC Sham (Sham Device)
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: autoRICExperimental Treatment1 Intervention
The autoRIC device will be used on subjects randomized to the treatment group.
Group II: autoRIC ShamPlacebo Group1 Intervention
The autoRIC Sham device will be used on subjects randomized to the control group.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
St. Michael's HospitalToronto, Canada
North Shore University HospitalManhasset, NY
William Osler Health SystemBrampton, Canada
University of Florida Health JacksonvilleJacksonville, FL
More Trial Locations
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Who Is Running the Clinical Trial?
CellAegis US, Inc.
Lead Sponsor
Trials
2
Patients Recruited
2,100+