Preventing Ischemic Cerebrovascular Events in High-Risk Patients With Non-disabling Ischemic Cerebrovascular Events Using Remote Ischemic Conditioning: A Single-Arm Study.

Abstract

Background: Secondary stroke prevention after a high-risk, non-disabling ischemic cerebrovascular event needs to be enhanced. The study was conducted to investigate whether remote ischemic conditioning (RIC) is effective in preventing recurrent ischemic events within 3 months. Methods: This was a four-center, single-arm, open-label Phase IIa futility trial (PICNIC-One Study). Adult patients (≥18 years of age) who had an acute minor ischemic stroke (AMIS) with a National Institutes of Health Stroke Scale score ≤ 3 or a transient ischemic attack (TIA) with moderate-to-high risk of stroke recurrence (ABCD score ≥ 4) within 14 days of symptom onset were recruited. Patients received RIC as adjunctive therapy to routine secondary stroke prevention regimen. RIC consisted of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuffs (45 min) on bilateral upper limbs twice a day for 90 days. Results: A total of 285 patients met the study criteria, of which 167 provided signed informed consent and were enrolled. Data from 162 were analyzed with five subjects excluded. Recurrent AIS/TIA occurred in 6/162 (3.7%) patients within 3 months, with no occurrence of hemorrhagic stroke. The top three adverse events were upper limb pain (44/162, 27.2%), petechia (26/162, 16.0%), and heart palpitation (5/162, 3.1%). About 68 (42.0%) subjects completed ≥ 50% of 45-min RIC sessions. Conclusions: RIC is a safe add-on procedure and it has a potential benefit in reducing recurrent cerebrovascular events in patients with high-risk, non-disabling ischemic cerebrovascular events as the risk of stroke/TIA events is lower than expected; however, its compliance needs to be improved. Our study provides critical preliminary data to plan a large sample size, randomized controlled clinical study to systematically investigate the safety and efficacy of RIC in this population.

Department

Description

Provenance

Subjects

acute minor ischemic stroke, remote ischemic conditioning, secondary prevention, stroke, transient ischemic attack

Citation

Published Version (Please cite this version)

10.3389/fneur.2021.748916

Publication Info

Liu, Shimeng, Zongen Gao, Ran Meng, Haiqing Song, Tianping Tang, Ya Zhao, Rong Chen, Yanzhen Sheng, et al. (2021). Preventing Ischemic Cerebrovascular Events in High-Risk Patients With Non-disabling Ischemic Cerebrovascular Events Using Remote Ischemic Conditioning: A Single-Arm Study. Frontiers in neurology, 12. p. 748916. 10.3389/fneur.2021.748916 Retrieved from https://hdl.handle.net/10161/34019.

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Scholars@Duke

Feng

Wuwei Feng

Professor of Neurology

Wayne Feng is the Chief of Division of Stroke & Vascular Neurology, Medical Director of Duke Comprehensive Stroke Center, and Tenured Profess of Neurology and Biomedical Engineering at Duke University School of Medicine. Dr. Feng is a board-certified vascular neurologist as well as a physician scientist. His research portfolios include developing imaging biomarker for post-stroke motor outcomes prediction, and use of non-invasive brain stimulation tools, such as, transcranial direct current stimulation (tDCS), vagus nerve stimulation, low intensity focused ultrasound and transcranial light stimulation to enhance post-stroke recovery. His research has been actively funded by the National Institute of Health (NIH), the American Heart Association/American Stroke Association (AHA/ASA) and other various sources.  He is currently leading an NIH funded 8.9 million U01 12-center, phase II study called TRANSPORT 2 (TRANScranial direct current stimulation for POst-stroke motor Recovery – a phase II sTudy) – on the NINDS funded stroke trial network.

Dr. Feng has published over 150 peer reviewed manuscripts (H index of 36), including two manuscripts featured on the cover page of brain stimulation journal, and one manuscript featured on Journal of Neuroscience. He co-edited - “Cerebral Venous System in Acute and Chronic Brain Injuries” book. He served as the associate editor for Translational Stroke Research from 2019 to 2021(IF=7.0). Dr. Feng received several prestigious awards for his research work in stroke and stroke recovery including the FIRST “Rehabilitation Award” from the American Heart Association/American Stroke Association in 2015, “Franz Gerstenbrand Award” from World Federation of Neurorehabilitation (WFNR) in 2016, Arthur Guyton New Investigator Award, Consortium for Southeastern Hypertension Control (COSEHC) in 2016 and “Clinical Investigator Award” from the Society of Chinese American Physician Entrepreneur (SCAPE). Currently, he is the Section Chair of Neural Repair & Rehabilitation, the American Academy of Neurology. He leads the global mentoring program for the WFNR. 


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