Preventing Ischemic Cerebrovascular Events in High-Risk Patients With Non-disabling Ischemic Cerebrovascular Events Using Remote Ischemic Conditioning : A Single-Arm Study
Copyright © 2021 Liu, Gao, Meng, Song, Tang, Zhao, Chen, Sheng, Fan, Jiang, Zhang, Ding, Huang, Ma, Dong, Xue, Yu, Duan, Chu, Chen, Huang, Li, Ovbiagele, Zhao, Ji and Feng..
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.
Medienart: |
E-Artikel |
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Erscheinungsjahr: |
2021 |
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Erschienen: |
2021 |
Enthalten in: |
Zur Gesamtaufnahme - volume:12 |
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Enthalten in: |
Frontiers in neurology - 12(2021) vom: 18., Seite 748916 |
Sprache: |
Englisch |
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Beteiligte Personen: |
Liu, Shimeng [VerfasserIn] |
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Links: |
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Themen: |
Acute minor ischemic stroke |
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Anmerkungen: |
Date Revised 04.01.2022 published: Electronic-eCollection Citation Status PubMed-not-MEDLINE |
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doi: |
10.3389/fneur.2021.748916 |
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funding: |
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Förderinstitution / Projekttitel: |
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PPN (Katalog-ID): |
NLM335111998 |
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520 | |a 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 | ||
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700 | 1 | |a Meng, Ran |e verfasserin |4 aut | |
700 | 1 | |a Song, Haiqing |e verfasserin |4 aut | |
700 | 1 | |a Tang, Tianping |e verfasserin |4 aut | |
700 | 1 | |a Zhao, Ya |e verfasserin |4 aut | |
700 | 1 | |a Chen, Rong |e verfasserin |4 aut | |
700 | 1 | |a Sheng, Yanzhen |e verfasserin |4 aut | |
700 | 1 | |a Fan, Qianqian |e verfasserin |4 aut | |
700 | 1 | |a Jiang, Fang |e verfasserin |4 aut | |
700 | 1 | |a Zhang, Qian |e verfasserin |4 aut | |
700 | 1 | |a Ding, Jianping |e verfasserin |4 aut | |
700 | 1 | |a Huang, Xiaoqin |e verfasserin |4 aut | |
700 | 1 | |a Ma, Qingfeng |e verfasserin |4 aut | |
700 | 1 | |a Dong, Kai |e verfasserin |4 aut | |
700 | 1 | |a Xue, Sufang |e verfasserin |4 aut | |
700 | 1 | |a Yu, Zhipeng |e verfasserin |4 aut | |
700 | 1 | |a Duan, Jiangang |e verfasserin |4 aut | |
700 | 1 | |a Chu, Changbiao |e verfasserin |4 aut | |
700 | 1 | |a Chen, Xiaohui |e verfasserin |4 aut | |
700 | 1 | |a Huang, Xingquan |e verfasserin |4 aut | |
700 | 1 | |a Li, Sijie |e verfasserin |4 aut | |
700 | 1 | |a Ovbiagele, Bruce |e verfasserin |4 aut | |
700 | 1 | |a Zhao, Wenle |e verfasserin |4 aut | |
700 | 1 | |a Ji, Xunming |e verfasserin |4 aut | |
700 | 1 | |a Feng, Wuwei |e verfasserin |4 aut | |
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