Clinical Trials Research Unit, Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, UK.
Royal Infirmary of Edinburgh, Edinburgh, UK.
BMJ Open. 2019 Sep 5;9(9):e032165. doi: 10.1136/bmjopen-2019-032165.
For non-ST-segment elevation acute coronary syndrome (NSTEACS) there is a gap between the use of class I guideline recommended therapies and clinical practice. The Global Registry of Acute Coronary Events (GRACE) risk score is recommended in international guidelines for the risk stratification of NSTEACS, but its impact on adherence to guideline-indicated treatments and reducing adverse clinical outcomes is unknown. The objective of the UK GRACE Risk Score Intervention Study (UKGRIS) trial is to assess the effectiveness of the GRACE risk score tool and associated treatment recommendations on the use of guideline-indicated care and clinical outcomes.
The UKGRIS, a parallel-group cluster randomised registry-based controlled trial, will allocate hospitals in a 1:1 ratio to manage NSTEACS by standard care or according to the GRACE risk score and associated international guidelines. UKGRIS will recruit a minimum of 3000 patients from at least 30 English National Health Service hospitals and collect healthcare data from national electronic health records. The co-primary endpoints are the use of guideline-indicated therapies, and the composite of cardiovascular death, non-fatal myocardial infarction, new onset heart failure hospitalisation or cardiovascular readmission at 12 months. Secondary endpoints include duration of inpatient hospital stay over 12 months, EQ-5D-5L responses and utilities, unscheduled revascularisation and the components of the composite endpoint over 12 months follow-up.
The study has ethical approval (North East - Tyne & Wear South Research Ethics Committee reference: 14/NE/1180). Findings will be announced at relevant conferences and published in peer-reviewed journals in line with the funder's open access policy.
ISRCTN29731761; Pre-results.
对于非 ST 段抬高型急性冠状动脉综合征（NSTEACS），指南推荐的 I 类治疗方法在临床实践中的应用存在差距。国际指南推荐全球急性冠状动脉事件注册（GRACE）风险评分用于 NSTEACS 的风险分层，但它对指南推荐治疗方法的依从性和降低不良临床结局的影响尚不清楚。英国 GRACE 风险评分干预研究（UKGRIS）试验的目的是评估 GRACE 风险评分工具及其相关治疗建议对指南推荐的护理使用和临床结局的有效性。
UKGRIS 是一项平行组聚类随机登记对照试验，将以 1:1 的比例将医院分配到标准护理组或根据 GRACE 风险评分和相关国际指南进行管理。UKGRIS 将从至少 30 家英国国家卫生服务医院招募至少 3000 名患者，并从国家电子健康记录中收集医疗保健数据。主要终点是指南推荐治疗方法的使用，以及 12 个月时心血管死亡、非致死性心肌梗死、新发心力衰竭住院或心血管再入院的复合终点。次要终点包括 12 个月内住院时间、EQ-5D-5L 反应和效用、非计划性血运重建以及 12 个月随访期间复合终点的组成部分。
该研究已获得伦理批准（东北-泰恩威尔南研究伦理委员会参考号：14/NE/1180）。研究结果将在相关会议上公布，并按照资助者的开放获取政策在同行评议期刊上发表。
ISRCTN29731761；预结果。
