TY - JOUR
T1 - Remote ischemic conditioning for acute ischemic stroke part 2
T2 - Study protocol for a randomized controlled trial
AU - Ishizuka, Kentaro
AU - Hoshino, Takao
AU - Toi, Sono
AU - Mizuno, Takafumi
AU - Hosoya, Megumi
AU - Saito, Moeko
AU - Sato, Yasuto
AU - Yagita, Yoshiki
AU - Todo, Kenichi
AU - Sakaguchi, Manabu
AU - Ohashi, Takashi
AU - Maruyama, Kenji
AU - Hino, Shuji
AU - Honma, Yutaka
AU - Doijiri, Ryosuke
AU - Yamagami, Hiroshi
AU - Iguchi, Yasuyuki
AU - Hirano, Teruyuki
AU - Kimura, Kazumi
AU - Kitazono, Takanari
AU - Kitagawa, Kazuo
N1 - Funding Information:
This study was supported in part by the Mihara Cerebrovascular Disorders Research Promotion Fund. The funding source had no role in the design or conduct of the study.
Publisher Copyright:
Copyright © 2022 Ishizuka, Hoshino, Toi, Mizuno, Hosoya, Saito, Sato, Yagita, Todo, Sakaguchi, Ohashi, Maruyama, Hino, Honma, Doijiri, Yamagami, Iguchi, Hirano, Kimura, Kitazono and Kitagawa.
PY - 2022/8/8
Y1 - 2022/8/8
N2 - Background: Remote ischemic conditioning (RIC) refers to the application of repeated short periods of ischemia intended to protect remote areas against tissue damage during and after prolonged ischemia. Aim: We aim to evaluate the efficacy of RIC, determined by the modified Rankin Scale (mRS) score at 90 days after stroke onset. Design and methods: This study is an investigator-initiated, multicenter, prospective, randomized, open-label, parallel-group clinical trial. The sample size is 400, comprising 200 patients who will receive RIC and 200 controls. The patients will be divided into three groups according to their National Institutes of Health Stroke Scale score at enrollment: 5–9, mild; 10–14, moderate; 15–20, severe. The RIC protocol will be comprised of four cycles, each consisting of 5 min of blood pressure cuff inflation (at 200 mmHg or 50 mmHg above the systolic blood pressure) followed by 5 min of reperfusion, with the cuff placed on the thigh on the unaffected side. The control group will only undergo blood pressure measurements before and after the intervention period. This trial is registered with the UMIN Clinical Trial Registry (https://www.umin.ac.jp/: UMIN000046225). Study outcome: The primary outcome will be a good functional outcome as determined by the mRS score at 90 days after stroke onset, with a target mRS score of 0–1 in the mild group, 0–2 in the moderate group, and 0–3 in the severe group. Discussion: This trial may help determine whether RIC should be recommended as a routine clinical strategy for patients with ischemic stroke.
AB - Background: Remote ischemic conditioning (RIC) refers to the application of repeated short periods of ischemia intended to protect remote areas against tissue damage during and after prolonged ischemia. Aim: We aim to evaluate the efficacy of RIC, determined by the modified Rankin Scale (mRS) score at 90 days after stroke onset. Design and methods: This study is an investigator-initiated, multicenter, prospective, randomized, open-label, parallel-group clinical trial. The sample size is 400, comprising 200 patients who will receive RIC and 200 controls. The patients will be divided into three groups according to their National Institutes of Health Stroke Scale score at enrollment: 5–9, mild; 10–14, moderate; 15–20, severe. The RIC protocol will be comprised of four cycles, each consisting of 5 min of blood pressure cuff inflation (at 200 mmHg or 50 mmHg above the systolic blood pressure) followed by 5 min of reperfusion, with the cuff placed on the thigh on the unaffected side. The control group will only undergo blood pressure measurements before and after the intervention period. This trial is registered with the UMIN Clinical Trial Registry (https://www.umin.ac.jp/: UMIN000046225). Study outcome: The primary outcome will be a good functional outcome as determined by the mRS score at 90 days after stroke onset, with a target mRS score of 0–1 in the mild group, 0–2 in the moderate group, and 0–3 in the severe group. Discussion: This trial may help determine whether RIC should be recommended as a routine clinical strategy for patients with ischemic stroke.
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U2 - 10.3389/fneur.2022.946431
DO - 10.3389/fneur.2022.946431
M3 - Article
AN - SCOPUS:85136869847
SN - 1664-2295
VL - 13
JO - Frontiers in Neurology
JF - Frontiers in Neurology
M1 - 946431
ER -