Dolmans L Servaas, Rutten Frans H, El Bartelink Marie-Louise, Seppenwoolde Gerdien, van Delft Sanne, Kappelle L Jaap, Hoes Arno W
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.
Saltro Diagnostic Center for Primary Care, Utrecht, The Netherlands.
BMC Neurol. 2015 Jul 28;15:119. doi: 10.1186/s12883-015-0388-z.
A Transient Ischaemic Attack (TIA) bears a high risk of a subsequent ischaemic stroke. Adequate diagnosis of a TIA should be followed immediately by the start of appropriate preventive therapy, including antiplatelets. The diagnosis of a TIA based on symptoms and signs only is notoriously difficult and biomarkers of brain ischaemia might improve the recognition, and target management and prognosis of TIA patients. Our aim is to quantify the added diagnostic value of serum biomarkers of brain ischaemia in patients suspected of TIA.
a cross-sectional diagnostic accuracy study with an additional six month follow-up period.
350 patients suspected of TIA in the primary care setting. Patients suspected of a TIA will be recruited by at least 200 general practitioners (GPs) in the catchment area of seven TIA outpatient clinics willing to participate in the study. In all patients a blood sample will be drawn as soon as possible after the patient has contacted the GP, but at least within 72 h after onset of symptoms. Participants will be referred by the GP to the regional TIA outpatient clinic for additional investigations, including brain imaging. The 'definite' diagnosis (reference standard) will be made by a panel consisting of three experienced neurologists who will use all available diagnostic information and the clinical information obtained during the outpatient clinic assessment, and a six month follow-up period. The diagnostic accuracy, and value in addition to signs and symptoms of candidate serum biomarkers will be assessed in terms of discrimination with C statistics, and calibration with plots. We aim to include 350 suspected cases, with 250 patients with indeed definite TIA (or minor stroke) according to the panel.
We hope to find novel biomarkers that will enable a rapid and accurate diagnosis of TIA. This would largely improve the management and prognosis of such patients.
ClinicalTrials.gov Identifier NCT01954329.
短暂性脑缺血发作（TIA）后续发生缺血性卒中的风险很高。TIA确诊后应立即开始适当的预防性治疗，包括使用抗血小板药物。仅基于症状和体征诊断TIA非常困难，脑缺血生物标志物可能会改善TIA患者的识别、靶向治疗及预后。我们的目的是量化脑缺血血清生物标志物在疑似TIA患者中的附加诊断价值。
一项横断面诊断准确性研究，并附加6个月的随访期。
基层医疗环境中350例疑似TIA的患者。在7家愿意参与研究的TIA门诊诊所的服务区域内，至少200名全科医生（GP）将招募疑似TIA的患者。所有患者在联系GP后应尽快采集血样，但至少在症状发作后72小时内。参与者将由GP转诊至区域TIA门诊进行进一步检查，包括脑成像。由三名经验丰富的神经科医生组成的小组将做出“明确”诊断（参考标准），他们将使用所有可用的诊断信息以及门诊评估期间获得的临床信息，并进行6个月的随访。候选血清生物标志物除症状和体征外的诊断准确性和价值将通过C统计量判别分析及绘图校准进行评估。我们的目标是纳入350例疑似病例，其中根据小组判断有250例患者确实患有明确的TIA（或轻度卒中）。
我们希望找到能够快速准确诊断TIA的新型生物标志物。这将极大地改善此类患者的治疗和预后。
ClinicalTrials.gov标识符NCT01954329。
