Abstract Body: Rationale: In animal models, remote ischemic conditioning (RIC) can reduce reperfusion injuries and the final infarct size, and it has been demonstrated to be safe and feasible in patients undergoing mechanical thrombectomy (MT). However, whether RIC could provide clinical benefits to patients with acute ischemic stroke (AIS) undergoing MT remains unknown.
Aims: To investigate the safety and efficacy of RIC in improving functional outcomes in patients with AIS treated with MT, and to explore the optimal treatment duration of RIC.
Sample size estimates: The sample size of 2105 patients will allow the mRS score of 0-2 at 90 days with an estimated difference of 8% (14-d RIC versus control) and 10% (30-d RIC versus control) to be detected with over 80% power at 5% significance (two-sided).
Design: The Safety and Efficacy of Remote Ischemic Conditioning for Acute Ischemic Stroke Treated with Mechanical Thrombectomy (RECAST-MT) is a multicenter, randomized, controlled, open-label, blinded endpoint trial conducted in China. The trial will enroll patients with AIS due to large vessel occlusion in the anterior circulation and planning to receive MT within 24 hours from the time last known well. All enrolled patients will be randomly assigned in a 1:1:1 ratio to a 14-day RIC group, 30-day RIC group, or control group. All patients will receive MT and the best medical management according to the guidelines.
Study outcomes: The primary outcome is the proportion of patients achieving a mRS score of 0-2 at 90 days. Secondary outcomes include dichotomous mRS scores at 90 days (0-1 vs 2-6, 0-3 vs 4-6, 0-4 vs. 5-6, 0-5 vs. 6), ordinal distribution of mRS scores at 90 days, the proportion of patients with early neurological improvement 24 hours after endovascular procedures, and cerebral infarct volume on the image. All outcomes and serious adverse events are adjudicated by individuals blinded to the treatment allocation.
Discussion: RECAST-MT will evaluate the safety and efficacy of RIC in patients with AIS treated with MT and may provide randomized evidence on RIC's role in improving the functional outcomes of patients with AIS undergoing MT.
Status: RECAST-MT has started recruiting patients from 47 centers in China since September 14, 2024, and is estimated to complete the final follow-up in February 2027.
Registration: The trial is registered with ClinicalTrials.gov, NCT06559241.