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Ischemic Conditioning Device

autoRIC for Ischemia Reperfusion Injury (SHIELD Trial)

N/A
Waitlist Available
Led By Roxana Mehran, MD
Research Sponsored by CellAegis US, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-24 hours

Summary

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.

Eligible Conditions
  • Ischemia Reperfusion Injury

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-24 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
(Primary Effectiveness) Attenuation of myocardial injury assessed by Cardiac Troponin I levels (cTnI)
(Primary Safety) Major Adverse Cardiac Events (MACE)
Secondary study objectives
Contrast-Induced Acute Kidney Injury (CI-AKI)
Myocardial Infarction

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
autoRIC
2016
N/A
~1630

Find a Location

Who is running the clinical trial?

CellAegis US, Inc.Lead Sponsor
1 Previous Clinical Trials
1,622 Total Patients Enrolled
Roxana Mehran, MDPrincipal InvestigatorCardiovascular Medicine Associates
16 Previous Clinical Trials
42,584 Total Patients Enrolled
~65 spots leftby Nov 2025
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