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Ischemic Conditioning During Air tRansport Save penUmbral Tissue

NCT ID: NCT03481205

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2026-12-31

Brief Summary

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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

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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)

Conditions

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Acute Stroke

Keywords

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remote limb ischemic conditioning large vessel occlusion helicopter transport

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Ischemic Conditioning

Doctormate device used en route to the comprehensive stroke center

Group Type EXPERIMENTAL

Ischemic conditioning device

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Standard medical care

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Enrique Leira

OTHER

Sponsor Role lead

Responsible Party

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Enrique Leira

Professor of Neurology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Enrique Leira, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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University of Iowa

Iowa City, Iowa, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Amir Shaban, MD

Role: CONTACT

Phone: 3193568755

Email: [email protected]

Other Identifiers

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201712791

Identifier Type: -

Identifier Source: org_study_id