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Ischemic Conditioning During Air tRansport Save penUmbral Tissue (ICARUS)

Primary Purpose

Acute Stroke

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ischemic conditioning device
Sponsored by
Amir Shaban
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Acute Stroke focused on measuring remote limb ischemic conditioning, large vessel occlusion, helicopter transport

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age ≥18 and ≤ 85 years
  2. Suspected acute ischemic stroke with symptoms suggestive of large vessel occlusion (aphasia, agnosia, neglect, visual field cut, and gaze preference).
  3. Patient screened for rtPA, and rtPA administered if eligible
  4. Subject or legally authorized representative able to provide consent at the time of the assessment
  5. NIHSS ≥ 6

Exclusion Criteria:

  1. Any intracranial hemorrhage (parenchymal, subarachnoid, subdural, epidural) on CT scan at the community hospital
  2. History of upper or lower extremity ischemia, known subclavian, brachial artery, iliac or femoral artery stenosis, subclavian steal syndrome, any upper or lower extremity soft tissue, orthopedic or vascular injury, or mastectomy or other procedure that may contraindicate taking blood pressure or having a cuff on the arm or leg for the conditioning treatment
  3. History of diabetes mellitus
  4. Enrollment in another clinical trial
  5. Patient incarcerated
  6. Pregnancy. Patients ages 18-55 will need to have a negative urine or blood based pregnancy test.
  7. Agitation deemed unsafe for ischemic preconditioning testing.

Sites / Locations

  • University of IowaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ischemic Conditioning

Arm Description

Doctormate device used en route to the comprehensive stroke center

Outcomes

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.
Feasibility will be assessed based on the number of cycles performed during transportation by air as follows: For flight time of duration of ≥ 60 minutes, ≥ 60% of subjects should receive 4 cycles of RLIC. For flight time of duration of 30-60 minutes, ≥ 60% of subjects should receive at least 3 cycles of RLIC. For flight duration of < 30 minutes, ≥60% of subjects should receive at least 2 cycle of RLIC.

Secondary Outcome Measures

Assess adverse events related to performing RLIC in patients with large vessel occlusion.
We will collect data on adverse events, severe and serious adverse events during transport, at 24 hours of hospital admission as well as at the 3 months follow up visit. An intendent medical monitor will be designated to evaluate the reported serious and related adverse events

Full Information

First Posted
March 13, 2018
Last Updated
March 1, 2023
Sponsor
Amir Shaban
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1. Study Identification

Unique Protocol Identification Number
NCT03481205
Brief Title
Ischemic Conditioning During Air tRansport Save penUmbral Tissue
Acronym
ICARUS
Official Title
Ischemic Conditioning During Air tRansport Save penUmbral Tissue
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Amir Shaban

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to demonstrate the feasibility of performing remote limb ischemic conditioning (RLIC) using the Doctormate device, a special blood pressure device used to perform RLIC, on patients with acute ischemic stroke due to large vessel occlusion being transported to a thrombectomy capable center by the helicopter.
Detailed Description
In this study, 15 subjects presenting to a community hospital with signs and symptoms of ischemic stroke due to large vessel occlusion, transported to a comprehensive stroke center by aircew will receive RLIC using the Doctormate device. The RLIC treatment will consist of 3-5 cycles ( depending on transportation time) of 5 minutes inflations of both blood pressure cuffs simultaneously. Blood pressure will be 200 mm HG with 5 minutes of reperfusion between each inflation. Subjects will be evaluated upon arrival to the comprehensive stroke center and evaluated for side effects. The study will be conducted at one site ( University of Iowa Hospitals and Clinics)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Stroke
Keywords
remote limb ischemic conditioning, large vessel occlusion, helicopter transport

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ischemic Conditioning
Arm Type
Experimental
Arm Description
Doctormate device used en route to the comprehensive stroke center
Intervention Type
Device
Intervention Name(s)
Ischemic conditioning device
Other Intervention Name(s)
Standard medical care
Intervention Description
RLIC will be done using a specialized blood pressure device ( Doctormate) that inflates to 200 mm HG for 5 minutes followed by 5 minutes deflation.
Primary Outcome Measure Information:
Title
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.
Description
Feasibility will be assessed based on the number of cycles performed during transportation by air as follows: For flight time of duration of ≥ 60 minutes, ≥ 60% of subjects should receive 4 cycles of RLIC. For flight time of duration of 30-60 minutes, ≥ 60% of subjects should receive at least 3 cycles of RLIC. For flight duration of < 30 minutes, ≥60% of subjects should receive at least 2 cycle of RLIC.
Time Frame
The duration of the flight, typically 30 min-3 hours depending on weather and distance of the community hospital
Secondary Outcome Measure Information:
Title
Assess adverse events related to performing RLIC in patients with large vessel occlusion.
Description
We will collect data on adverse events, severe and serious adverse events during transport, at 24 hours of hospital admission as well as at the 3 months follow up visit. An intendent medical monitor will be designated to evaluate the reported serious and related adverse events
Time Frame
AEs will be assessed during transport by aircrew, at 24 hours of admission and at 90 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age ≥18 and ≤ 80 years Suspected acute ischemic stroke with symptoms suggestive of large vessel occlusion (aphasia, agnosia, neglect, visual field cut, and gaze preference). Patient screened for rtPA, and rtPA administered if eligible Subject or legally authorized representative able to provide consent at the time of the assessment NIHSS 6-20 Exclusion Criteria: Any intracranial hemorrhage (parenchymal, subarachnoid, subdural, epidural) on CT scan at the community hospital History of upper or lower extremity ischemia, known subclavian, brachial artery, iliac or femoral artery stenosis, subclavian steal syndrome, any upper or lower extremity soft tissue, orthopedic or vascular injury, or mastectomy or other procedure that may contraindicate taking blood pressure or having a cuff on the arm or leg for the conditioning treatment History of diabetes mellitus Enrollment in another clinical trial Patient incarcerated Pregnancy. Patients ages 18-55 will need to have a negative urine or blood based pregnancy test. Agitation deemed unsafe for ischemic preconditioning testing. Arteriovenous fistula in upper limb
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amir Shaban, MD
Phone
3193568755
Email
amir-shaban@uiowa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amir Shaban, MD
Organizational Affiliation
University of Iowa Hospitals and Clinics- 200 Hawkins Dr, Iowa City, IA 52242
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amir Shaban, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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