Ischemic Conditioning During Air tRansport Save penUmbral Tissue

NCT03481205 | Recruiting DMC FDA Device

• 1 other identifier: 201712791
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Stroke

Keywords

remote limb ischemic conditioning; large vessel occlusion; helicopter transport

Outcome Measures

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.

  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 Outcomes (1)

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

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

Study Arms (1)

Ischemic Conditioning

EXPERIMENTAL

Doctormate device used en route to the comprehensive stroke center

Device: Ischemic conditioning device

Interventions

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.

Also known as: Standard medical care

Ischemic Conditioning

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Enrique Leira: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Enrique Leira, MD

  University of Iowa Hospitals and Clinics- 200 Hawkins Dr, Iowa City, IA 52242

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amir Shaban, MD

CONTACT

3193568755; amir-shaban@uiowa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: March 29, 2018
• Study Start: June 1, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)