Ischemic Conditioning During Air tRansport Save penUmbral Tissue

Acute Stroke Clinical Trial

— ICARUS  

Official title:

Ischemic Conditioning During Air tRansport Save penUmbral Tissue

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03481205
• Other study ID #: 201712791
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: April 1, 2025

Study information

• Verified date: May 2024
• Source: University of Iowa
• Contact: Amir Shaban, MD
• Phone: 3193568755
• Email: amir-shaban[@]uiowa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: April 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age =18 and = 80 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 6-20

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.

8. Arteriovenous fistula in upper limb

Related Conditions & MeSH terms

• Acute Stroke
• Stroke

Intervention

Device:
• Ischemic conditioning device
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.

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Enrique Leira

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	The duration of the flight, typically 30 min-3 hours depending on weather and distance of the community hospital
Secondary	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	AEs will be assessed during transport by aircrew, at 24 hours of admission and at 90 days.