The purpose of this study is to learn about protecting the brain from low blood flow (ischemia) with limb preconditioning. From human studies the investigators know that the brain can be protected from dangerous low blood flow by reducing the blood flow to an arm or leg for just a short period of time. This is called limb preconditioning. The investigators are studying the safety and feasibility of preconditioning and their effect of protecting the brain from ischemia in two different groups. This is a Phase 2, randomized, double-blind, sham-controlled, design. Up to 50 male and female patients undergoing elective endovascular repair of unruptured brain aneurysm who are randomized to the remote ischemic preconditioned or sham group will be enrolled. This study consists of one 3-9 month study period for each patient plus up to 14 days for enrollment activities. Subjects are required to return between 3-9 months for end-of-study procedures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Use of a standard manual blood pressure cuff and manometer for the conditioning intervention.
Jackson Memorial Hospital
Miami, Florida, United States
University of Miami
Miami, Florida, United States
Incidence of all adverse events and serious adverse events.
Adverse events are all conditions/symptoms/findings and all abnormal clinically significant laboratory tests both expected and unexpected, occurring from onset of the intervention until study completion.
Time frame: 9 months
Change in procedurally-induced vascular cognitive impairment.
As measured by the NIH-toolbox for neurocognitive testing.NIH-Toolbox normalized scores to define a single cognitive battery index.C. Score:0= No deficit, no change; 400= Maximum deficit.
Time frame: Baseline, Day 2-4
Change in procedurally-induced vascular cognitive impairment.
As measured by the NIH-toolbox for neurocognitive testing. NIH-Toolbox normalized scores to define a single cognitive battery index.C. Score:0= No deficit, no change; 400= Maximum deficit
Time frame: Baseline, 3-9 months.
Volume of embolic strokes by Diffusion Weighted Imaging (DWI).
Measured in select patients by Diffusion Weighted Imaging (DWI) via Magnetic Resonance Imaging (MRI) that undergo 4 cycles of 5 minutes of limb ischemia followed by 5 minutes reperfusion.
Time frame: Timeframe: Baseline, 12-96 hours post procedures
Volume of embolic strokes by Fluid-attenuated Inversion Recovery (FLAIR).
Measured in select patients by Fluid-attenuated Inversion Recovery (FLAIR) via Magnetic Resonance Imaging (MRI) that undergo 4 cycles of 5 minutes of limb ischemia followed by 5 minutes reperfusion.
Time frame: Timeframe: Baseline, 12-96 hours post procedures.
Frequency of large (>10 cc value) strokes.
As measured by MRI imaging when performed.
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Time frame: 2-4 days post procedures.