Glycaemia and ischaemia-reperfusion brain injury in patients with ischaemic stroke treated with mechanical thrombectomy (GLIAS-MT): an observational, unicentric, prospective study protocol

Autor: Laura González, Pedro Navia, Ricardo Rigual, Blanca Fuentes, María Alonso de Leciñana, Remedios Frutos, Elena de Celis-Ruiz, Maria Gutiérrez-Fernández, Jorge Rodríguez-Pardo, Carlos Hervás, Irene Peirotén, Elisa Alonso-López, Laura Casado, Andrés Francisco Fernández Prieto, Rebeca Gallego-Ruiz, Noemí González Pérez de Villar, Laura Otero-Ortega, Javier Pozo-Novoa, Gerardo Ruiz
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: BMJ Open, Vol 14, Iss 8 (2024)
Druh dokumentu: article
ISSN: 2044-6055
DOI: 10.1136/bmjopen-2024-086745
Popis: Introduction Poststroke hyperglycaemia is an independent risk factor for poorer outcomes in patients treated with mechanical thrombectomy (MT) and is associated with a lower probability of functional recovery and higher mortality at 3 months. This study aims to evaluate the association between glucose levels during cerebral reperfusion with MT and functional recovery at 3 months, measured by subcutaneous continuous glucose monitoring (CGM) devices.Methods This prospective observational study aims to recruit 100 patients with ischaemic stroke and large anterior circulation vessel occlusion, in whom MT is indicated. CGM will be performed using a Freestyle Libre ProIQ device (FSL-CGM, Abbott Diabetes Care, Alameda, California, USA), which will be implanted on admission to the emergency department, to monitor glucose levels before, during and after reperfusion. The study’s primary endpoint will be the functional status at 3 months, as measured by the dichotomised modified Rankin Scale (0–2 indicating good recovery and 3–6 indicating dependency or death). We will analyse expression profiles of microRNA (miRNA) at the time of reperfusion and 24 hours later, as potential biomarkers of ischaemic-reperfusion injury. The most promising miRNAs include miR-100, miR-29b, miR-339, miR-15a and miR-424. All patients will undergo treatment according to current international recommendations and local protocols for the treatment of stroke, including intravenous thrombolysis if indicated.Ethics and dissemination This study (protocol V.1.1, dated 29 October 2021, code 6017) has been approved by the Clinical Research Ethics Committee of La Paz University Hospital (Madrid, Spain) and has been registered in ClinicalTrials.gov (NCT 05871502). Study results will be disseminated through peer-reviewed publications in Open Access format and at conference presentations.Trial registration number NCT05871502.
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