Safety and efficacy of remote ischemic conditioning combined with endovascular thrombectomy for acute ischemic stroke due to large vessel occlusion of anterior circulation: A multicenter,randomized,parallel-controlled clinical trial (SERIC-EVT): Study protocol

Abstract

Rationale/Aim:

Many patients undergoing successful recanalization after endovascular thrombectomy (EVT) do not have a good outcome; additional neuroprotection might benefit this group. Remote ischemic conditioning (RIC) stimulates endogenous protective mechanisms and may have a neuroprotective in acute brain ischemia. The safety and efficacy of RIC combined with endovascular thrombectomy (SERIC-EVT) trial is investigating the safety and efficacy of RIC for patients with acute ischemic stroke (AIS) who underwent EVT due to large vessel occlusion of the anterior circulation.

Methods:

SERIC-EVT is a multicenter, randomized, parallel-controlled, and blinded endpoint clinical trial. Patients are recruited from 10 hospitals in Jilin Province, Northeast China. Patients with anterior circulation AIS undergoing EVT due to large vessel occlusion are randomized in a 1:1 ratio to RIC or sham-RIC. Participants will receive standard medical treatment and an inflation pressure of 200 mmHg (RIC group) or 60 mmHg (sham-RIC group) twice daily for seven consecutive days.

Study outcomes:

The primary outcome is the proportion of patients with modified Rankin Scale (mRS) score of 0–2 on day 90. Secondary outcome measures include the National Institute of Health Stroke Scale, Barthel Index, and mRS scores obtained at 24 h, 7 days, 30 ± 3 days, and 90 ± 3 days post-EVT, recanalization rate, expanded Thrombolysis in Cerebral Infarction score, and symptomatic intracranial hemorrhage post-EVT. Mortality and all adverse events, including skin changes and pain scores, within the first 90 days will be used as safety outcome measures.

Sample size estimates:

Based on previous studies, we estimate a 14% difference in functional independence (the mRS ⩽2) between RIC and sham-RIC groups. Considering a significance level of 5% and power of 80%, and one-fifth of patients lost to follow up, the planned sample size is 498 patients (249 per group).

Discussion:

RIC might be a strategy that improves 3-month clinical outcomes in AIS patients who have undergone EVT due to large vessel occlusion of anterior circulation. SERIC-EVT will determine whether this is the case.