Self- or caregiver-delivered manual remote ischemic conditioning therapy in acute ischemic stroke is feasible: the Early Remote Ischemic Conditioning in Stroke (ERICS) trial

Abstract

Background: Infarct growth and recurrent stroke may be responsible for early morbidity and mortality in patients with acute ischemic stroke. Remote ischemic conditioning (RIC) may reduce infarct growth and prevent recurrent stroke; however, the exact dose remains to be investigated. We hypothesized that self- or caregiver-delivered six cycles of RIC intervention in acute ischaemic stroke for the first 12 weeks is feasible and safe compared to the four cycles RIC intervention. Methods: Adult ischemic stroke patients presenting within the first 48 h of symptom onset were screened. Patients with magnetic resonance imaging (MRI) evidence of acute infarct were randomized (1:1) to receive either four or six cycles of RIC therapy sessions two times daily in both arms for 12 weeks. All patients underwent MRI for infarct volume assessment and endothelial-dependent flow-mediated dilation (EDFMD) testing at baseline, 7 days and 12 weeks. Results: A total of 57 patients with mean±SD age of 59.4±12.4 years and median National Institute of Stroke Scale, 4 (IQR, 3-7) were randomised at a median of 23 h 30 min (IQR, 10 h 20 min to 30 h) after symptom onset to either the four-cycle (n=27) or six-cycle group (n=30). A total of 18 (66%) patients completed ≥50% sessions in 12 weeks in the four-cycles group; 21 (69.7%) patients completed ≥50% sessions in 12 weeks in the six-cycle group (p=0.4). There was no between-group differences in infarct growth, early neurological deterioration, recurrent stroke, and EDFMD at 7 days and 90 days. Conclusion: Both four and six cycles of short-term self- or caregiver-delivered RIC therapy is safe and may be feasible in acute ischaemic stroke patients. Randomised clinical trials are needed to assess efficacy to decrease infarct growth and prevent early neurological deterioration. Registration: Clinical Trial Registry - India: CTRI/2016/11/007495; registered on 25/11/2016.