Remote Ischemic PreConditioning Provides Neuroprotection: A Phase 2, Single Center, Randomized, Double-Blind, Sham-Controlled, Safety and Efficacy Study Evaluating the Use of Remote Ischemic Preconditioning in Patients Undergoing Endovascular Repair of Brain Aneurysms
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Unruptured Cerebral Aneurysm
- Sponsor
- Sebastian Koch
- Locations
- 2
- Primary Endpoint
- Change in procedurally-induced vascular cognitive impairment.
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Sebastian Koch
Professor of Clinical Neurology
University of Miami
Eligibility Criteria
Inclusion Criteria
- •A diagnosis of an unruptured brain aneurysm deemed suitable for repair by neuroendovascular techniques involving intraluminal occlusion by detachable platinum coils, stent-assisted coiling, pipeline stent, balloon-assisted coiling, covered stent only, neck-bridge device, re-coiling, or re-treatment of a previously coiled/treated aneurysm. There are no restrictions on adjunctive devices.
- •Absence of ongoing ischemic symptoms such as transient ischemic attacks, minor strokes, stroke-in-evolution, or clinical evidence of cerebral vasospasm within 2 weeks prior to randomization. (If a CT scan, cerebral angiogram, or other imaging performed during the 2 weeks prior to randomization shows radiological vasospasm deemed by the treating physician to be potentially clinically significant, the subject is excluded).
- •Male or female with a minimum age of 18 years on the day of enrollment.
- •Informed consent and availability of the subject for the entire study period and willingness of the subject to adhere to protocol requirements, as evidenced by a signed Informed Consent Form.
Exclusion Criteria
- •Dissecting or mycotic brain aneurysm. Fusiform or atherosclerotic intracerebral aneurysms may be eligible for the trial if endovascular treatment is planned with a goal of exclusion of the aneurysm from the circulation.
- •Planned endovascular vessel sacrifice as the primary modality for aneurysm treatment.
- •Known history of life-threatening allergic reaction to any medication.
- •Soft tissue, orthopedic, or vascular injury which, in the judgment of the investigator, would preclude arm ischemic conditioning (e.g. superficial wounds, venous, arterial ulcers, gangrene).
- •History of peripheral vascular disease or deep vein thrombosis in either arm.
- •Women who are pregnant, or have a positive urine or blood (β-hCG) pregnancy test.
- •Women who are breastfeeding.
- •Any clinically significant psychiatric or psychological disease, which would preclude the patient from completing the protocol.
- •Pre-morbid (estimated) modified Rankin scale score of greater than
- •A subject is not excluded if they have a pre-morbid modified Rankin scale of greater than 2 but the disability does not interfere with the subject's ability to complete an MRI and the cognitive evaluations.
Outcomes
Primary Outcomes
Change in procedurally-induced vascular cognitive impairment.
Time Frame: Baseline, Day 2-4
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.
Incidence of all adverse events and serious adverse events.
Time Frame: 9 months
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.
Secondary Outcomes
- Change in procedurally-induced vascular cognitive impairment.(Baseline, 3-9 months.)
- Volume of embolic strokes by Fluid-attenuated Inversion Recovery (FLAIR).(Timeframe: Baseline, 12-96 hours post procedures.)
- Volume of embolic strokes by Diffusion Weighted Imaging (DWI).(Timeframe: Baseline, 12-96 hours post procedures)
- Frequency of large (>10 cc value) strokes.(2-4 days post procedures.)