Remote ischemic conditioning for acute ischemic stroke part 2: Study protocol for a randomized controlled trial.
acute ischemic stroke
good functional outcome
neurological severity
randomized controlled trial
remote ischemic conditioning (RIC)
Journal
Frontiers in neurology
ISSN: 1664-2295
Titre abrégé: Front Neurol
Pays: Switzerland
ID NLM: 101546899
Informations de publication
Date de publication:
2022
2022
Historique:
received:
17
05
2022
accepted:
14
07
2022
entrez:
25
8
2022
pubmed:
26
8
2022
medline:
26
8
2022
Statut:
epublish
Résumé
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. We aim to evaluate the efficacy of RIC, determined by the modified Rankin Scale (mRS) score at 90 days after stroke onset. 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). 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. This trial may help determine whether RIC should be recommended as a routine clinical strategy for patients with ischemic stroke.
Sections du résumé
Background
UNASSIGNED
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
UNASSIGNED
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
UNASSIGNED
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
UNASSIGNED
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
UNASSIGNED
This trial may help determine whether RIC should be recommended as a routine clinical strategy for patients with ischemic stroke.
Identifiants
pubmed: 36003294
doi: 10.3389/fneur.2022.946431
pmc: PMC9393485
doi:
Types de publication
Journal Article
Langues
eng
Pagination
946431Informations de 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.
Déclaration de conflit d'intérêts
KKit received grants and personal fees from Daiichi Sankyo, Kyowa Hakko Kirin, Bayer Inc., Sanofi, Nippon Boehringer Ingelheim, Takeda Pharmaceutical, and Sumitomo Dainippon Pharma as well as personal fees from Astellas Pharma outside the submitted work. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
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