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NCT Number: NCT03481205

Ischemic Conditioning During Air tRansport Save penUmbral Tissue

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.

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Key information

Conditions

Acute Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa

Iowa City, Iowa, 52242, United States

Location status: Recruiting

Location contact

Enrique Leira, MD

PRINCIPAL_INVESTIGATOR

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ischemic conditioning device

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.

Other names: Standard medical care

Primary outcomes

  1. 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.

    Time frame: The duration of the flight, typically 30 min-3 hours depending on weather and distance of the community hospital

    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 outcomes

  1. Assess adverse events related to performing RLIC in patients with large vessel occlusion.

    Time frame: AEs will be assessed during transport by aircrew, at 24 hours of admission and at 90 days.

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Amir Shaban, MD

CONTACT

[email protected]

3193568755

Sponsors and collaborators

Lead sponsor

Enrique Leira

Other

Registry information

Acronym: ICARUS

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Mar 29, 2018
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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