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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)
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

ICARUS Trial 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.Check my eligibility
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.See study design
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.

ICARUS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I was evaluated for and received rtPA treatment if I was eligible.
Select...
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.
Select...
I am between 18 and 80 years old.

ICARUS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Assess adverse events related to performing RLIC in patients with large vessel occlusion.

ICARUS 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently enrolled in this research?

"Affirmative. According to the clinicaltrials.gov listing, this research project is currently open for recruitment which began on June 1st 2020 and was recently updated on February 7th 2022. A total of 10 patients will be accepted across one site."

Answered by AI

Is it possible for me to take part in this experiment?

"This trial is seeking 10 individuals aged between 18 and 80 with acute stroke. To be considered, applicants must meet the age requirement (18-85 years old) and have a legally authorized representative able to provide consent during assessment."

Answered by AI

Are there age limitations on participation in this medical experiment?

"Candidates eligible for this medical trial must be over the age of 18 but below 80 years old."

Answered by AI

Is enrollment still accessible for this experiment?

"Affirmative. Clinicaltrials.gov indicates that this clinical trial is actively looking for volunteers, with the first post being made on June 1st 2020 and last edited February 7th 2022. The research necessitates 10 individuals from a single site to participate in the study."

Answered by AI
~1 spots leftby Dec 2024