Multi-Center Randomized Phase II Clinical Trial on Remote Ischemic Conditioning in Acute Ischemic Stroke Within 9 Hours of Onset in Patients Ineligible to Recanalization Therapies (TRICS-9): Study Design and Protocol
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Le résumé fourni par la source
Aim: To assess the efficacy of remote ischemic conditioning (RIC) in patients with ischemic stroke within 9 h of onset, that are not candidates for recanalization therapies. Sample Size Estimates: A sample size of 80 patients (40 in each arm) should yield 80% power to detect a 20% difference in early neurological improvement at 72 h at p = 0.05, two sided. Methods and Design: TRICS-9 is a phase II, multicenter, controlled, block randomized, open-label, interventional clinical trial. Patients recruited in Italian academic hospitals will be randomized 1:1 to either RIC plus standard medical therapy or standard medical therapy alone. After randomization, RIC will be applied manually by four alternating cycles of inflation/deflation 5 min each, using a blood pressure cuff around the non-paretic arm. Study Outcomes: The primary efficacy outcome is early neurological improvement, defined as the percent change in the National Institute of Health Stroke Scale (NIHSS) at 72 h in each arm. Secondary outcomes include early neurologic improvement at 24 and 48 h, disability at 3 months, rate of symptomatic intracerebral hemorrhage, feasibility (proportion of patients completing RIC), tolerability after RIC and at 72 h, blood levels of HIF-1α, and HSP27 at 24 h and 72 h. Discussion/Conclusion: RIC in combination with recanalization therapies appears to add no clinical benefit to patients, but whether it is beneficial to those that are not candidates for recanalization therapies is still to be demonstrated. TRICS-9 has been developed to elucidate this issue. Clinical Trial Registration: ClinicalTrials.gov , identifier: NCT04400981.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Multi-Center Randomized Phase II Clinical Trial on Remote Ischemic Conditioning in Acute Ischemic Stroke Within 9 Hours of Onset in Patients Ineligible to Recanalization Therapies (TRICS-9): Study Design and Protocol
- Date Crossref
- 03/11/2021
- Éditeur
- Frontiers Media SA
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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University of Milano-Bicocca Azienda Socio Sanitaria Territoriale (ASST)-Monza San Gerardo Hospital pays non établi dans la noticeUniversité ou école supérieure
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Istituti di Ricovero e Cura a Carattere Scientifico pays non établi dans la noticeÉtablissement de santé
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University of L'Aquila Department of Applied Clinical Sciences and Biotechnology pays non établi dans la noticeUniversité ou école supérieure
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Azienda Ospedaliera Sant'Andrea pays non établi dans la noticeÉtablissement de santé
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Sapienza University of Rome pays non établi dans la noticeUniversité ou école supérieure
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Dipartimento di Ricerca Neuroscienze pays non établi dans la noticeInstitution
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Faculty of Medicine and Psychology NEuroscienze Salute Mentale e Organi di Senso (NESMOS) Department pays non établi dans la noticeUniversité ou école supérieure
Azienda Socio Sanitaria Territoriale (ASST)-Monza San Gerardo Hospital — University of Milano-Bicocca, Istituti di Ricovero e Cura a Carattere Scientifico et Department of Applied Clinical Sciences and Biotechnology — University of L'Aquila, avec 4 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.