Hervás Carlos, Peirotén Irene, González Laura, Alonso de Leciñana María, Alonso-López Elisa, Casado Laura, De Celis-Ruíz Elena, Fernández Prieto Andrés Francisco, Frutos Remedios, Gallego-Ruiz Rebeca, González Pérez de Villar Noemí, Gutiérrez-Fernández María, Navia Pedro, Otero-Ortega Laura, Pozo-Novoa Javier, Rigual Ricardo, Rodríguez-Pardo Jorge, Ruiz Gerardo, Fuentes Blanca
Department of Neurology and Stroke Centre, La Paz University Hospital and Department of Medicine, Universidad Autónoma de Madrid, La Paz University Hospital Research Institute (IdiPAZ), Madrid, Spain.
Department of Radiology (Neurointerventional Radiology), La Paz University Hospital, La Paz University Hospital Research Institute (IdiPAZ), Madrid, Spain.
BMJ Open. 2024 Aug 7;14(8):e086745. doi: 10.1136/bmjopen-2024-086745.
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.
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.
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 (NCT05871502). Study results will be disseminated through peer-reviewed publications in Open Access format and at conference presentations.
NCT05871502.
卒中后高血糖是接受机械取栓术（MT）治疗的患者预后较差的独立危险因素，与功能恢复的可能性较低及3个月时较高的死亡率相关。本研究旨在通过皮下连续血糖监测（CGM）设备评估脑灌注再通期间血糖水平与MT术后3个月功能恢复之间的关联。
这项前瞻性观察性研究旨在招募100例缺血性卒中且伴有大脑前循环大血管闭塞、适合MT治疗的患者。将使用Freestyle Libre ProIQ设备（FSL-CGM，美国加利福尼亚州阿拉米达市雅培糖尿病护理公司）进行CGM，该设备将在急诊科入院时植入，以监测再灌注前、期间和之后的血糖水平。研究的主要终点将是3个月时的功能状态，通过二分法改良Rankin量表进行测量（0-2表示恢复良好，3-6表示依赖或死亡）。我们将分析再灌注时和24小时后的微小RNA（miRNA）表达谱，作为缺血再灌注损伤的潜在生物标志物。最有前景的miRNA包括miR-100、miR-29b、miR-339、miR-15a和miR-424。所有患者将根据当前国际推荐和当地卒中治疗方案接受治疗，包括在有指征时进行静脉溶栓。
本研究（方案V.1.1，日期为2021年10月29日，代码6017）已获得拉巴斯大学医院（西班牙马德里）临床研究伦理委员会的批准，并已在ClinicalTrials.gov（NCT05871502）注册。研究结果将通过开放获取格式的同行评审出版物和会议报告进行传播。
NCT05871502。
