RecruitingNot ApplicableNCT03481205

Ischemic Conditioning During Air tRansport Save penUmbral Tissue


Sponsor

Enrique Leira

Enrollment

10 participants

Start Date

Jun 1, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria5

  • 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 Criteria8

  • 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

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Interventions

DEVICEIschemic 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(1)

University of Iowa

Iowa City, Iowa, United States

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NCT03481205


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