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Ischemic Conditioning Device for Stroke (ICARUS Trial)

N/A
Recruiting
Led By Amir Shaban, MD
Research Sponsored by Amir Shaban
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient screened for rtPA, and rtPA administered if eligible
Suspected acute ischemic stroke with symptoms suggestive of large vessel occlusion (aphasia, agnosia, neglect, visual field cut, and gaze preference)
Must not have
History of diabetes mellitus
Arteriovenous fistula in upper limb
Timeline
Screening 3 weeks
Treatment Varies
Follow Up aes will be assessed during transport by aircrew, at 24 hours of admission and at 90 days.
Awards & highlights

Summary

This trial tests whether a device that temporarily cuts off blood flow to the limbs can help prevent damage from a stroke caused by a blockage in a large blood vessel.

Who is the study for?
This trial is for adults aged 18-80 who have had a stroke due to a blocked large vessel and show certain symptoms like speech difficulty or vision loss. They must be able to consent, not be in another study, not pregnant (women under 55 need a test), and without diabetes, limb injuries, or other specific vascular issues.
What is being tested?
The trial tests the Doctormate device on stroke patients during helicopter transport to see if it can protect brain tissue by temporarily restricting blood flow in a limb. The goal is to improve outcomes for those heading for clot removal procedures.
What are the potential side effects?
Possible side effects may include discomfort from the blood pressure cuff used by the Doctormate device and potential bruising or soreness in the limb where ischemic conditioning is applied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I was evaluated for and received rtPA treatment if I was eligible.
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I am experiencing symptoms like difficulty speaking or understanding, ignoring one side of my body, vision problems, or difficulty controlling my gaze, which may suggest a stroke.
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I am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have diabetes.
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I have an abnormal connection between an artery and a vein in my arm.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~aes will be assessed during transport by aircrew, at 24 hours of admission and at 90 days.
This trial's timeline: 3 weeks for screening, Varies for treatment, and aes will be assessed during transport by aircrew, at 24 hours of admission and at 90 days. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Evaluate the feasibility of delivering RLIC by air medical crews in patients with AIS. This will be assessed by recording the number of cycles completed during transport.
Secondary study objectives
Assess adverse events related to performing RLIC in patients with large vessel occlusion.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Ischemic ConditioningExperimental Treatment1 Intervention
Doctormate device used en route to the comprehensive stroke center

Find a Location

Who is running the clinical trial?

Amir ShabanLead Sponsor
Enrique LeiraLead Sponsor
Amir Shaban, MDPrincipal Investigator - University of Iowa Hospitals and Clinics- 200 Hawkins Dr, Iowa City, IA 52242
University of Iowa Chemical Dependency Center, University of Iowa Hospitals & Clinics

Media Library

Ischemic conditioning device Clinical Trial Eligibility Overview. Trial Name: NCT03481205 — N/A
Stroke Research Study Groups: Ischemic Conditioning
Stroke Clinical Trial 2023: Ischemic conditioning device Highlights & Side Effects. Trial Name: NCT03481205 — N/A
Ischemic conditioning device 2023 Treatment Timeline for Medical Study. Trial Name: NCT03481205 — N/A
~1 spots leftby Dec 2024
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