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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
Awards & highlights

SHIELD Trial 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 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).

Eligible Conditions
  • Ischemia Reperfusion Injury

SHIELD Trial 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

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

SHIELD 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
15 Previous Clinical Trials
42,166 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Remote Ischemic Conditioning Using the autoRIC
2018. "Remote Ischemic Conditioning Using the autoRIC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03318575.
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