Remote Ischemic Conditioning in Acute Ischemic Stroke – A Clinical Trial Design

Abstract

Remote ischemic conditioning represents an intervention based on blood flow reduction applied at a distance from the lesion. The mechanism is supposed to elicit neurovascular protection, anti-inflammatory action, reduced excitotoxicity and metabolic protection. This study aims to explore the efficiency and safety of remote ischemic conditioning during the first five days following in patients who are ineligible for reperfusion treatment (intravenous thrombolysis or/and mechanical thrombectomy). We hypothesized that this intervention would reduce the infarct size (neuroprotection in the reperfusion window) and improve functional recovery. We aim to conduct a double-blind controlled trial, multicenter in two hospitals in Romania. Two hundred patients with acute ischemic stroke randomly divided into an experimental group and a control group will be included. The subjects in the experimental group will be subjected to remote ischemic conditioning twice daily with a maximum of 180 mmHg for 5 days, and a guideline- based treatment as well. The subjects in the control group will receive cuff inflation to 30 mmHg, which will induce sham preconditioning. The primary outcome measure will be radiological - the difference between baseline brain infarct volume and the volume at 180 days in the experimental group versus the control group. The second outcome considers clinical scores such as NIHSS, mRS, IADL, ADL, MOCA, PHQ-9 at baseline, 90 and 180 days; tolerance and side effects of remote ischemic conditioning; the reccurence of stroke or other vascular events at 180 days; incidence of stroke-associated comorbidities and the proportion of death of any cause within 180 days.