Albaqami Bader, Dinnes Jacqueline, Moore Theresa Hm, Kirby Kim, Carley Simon D, Aloufi Mohammad, Alqurashi Naif, Alghamdi Abdulrhman, Alsuwais Sara, Dawson Sarah, Body Richard
Division of Cardiovascular Sciences, The University of Manchester, Manchester, UK
University of Bisha, Bisha, Saudi Arabia.
BMJ Open. 2025 May 2;15(5):e094390. doi: 10.1136/bmjopen-2024-094390.
Chest pain is a major cause of emergency ambulance calls, often linked to acute myocardial infarction (AMI), a critical condition requiring immediate hospitalisation. Current diagnostic methods, such as history taking and ECG, have limitations, especially for non-ST-elevation myocardial infarction. High-sensitivity cardiac troponin (cTn) assays are more diagnostically sensitive, but the downside is that it needs hospital-based testing, which can delay diagnosis and the necessary treatment protocol. Point-of-care cTn testing, on the other hand, is much faster and done nearer to the patient; hence, it may fundamentally change the prehospital care pathway in terms of diagnostic accuracy, clinical utility and related safety.
To present a protocol for a systematic review and meta-analysis that will assess the diagnostic accuracy, clinical utility and safety of point of care (POC) troponin tests, with or without clinical decision aids, for ruling out AMI in adults presenting with cardiac chest pain to emergency ambulance services in prehospital settings.
This protocol follows BMJ guidelines and adheres to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols 2015 reporting standards. It is registered with PROSPERO (ID: CRD42024533117). A comprehensive search strategy will identify relevant studies in MEDLINE, EMBASE and CINAHL, focusing on literature from 2000 onwards. Eligibility criteria include adults with chest pain suspected of AMI, excluding those with ST-elevation myocardial infarction. The primary target is type 1 AMI, with secondary outcomes including major adverse cardiac events at 30 days. Risk of bias assessment will be performed using tools such as Quality Assessment of Diagnostic Accuracy Studies version 2, Risk of Bias 2, and Risk of Bias in Non-randomised Studies of Interventions, while the quality of the economic evaluations will be appraised using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist. Data items extracted will include patient demographics, test characteristics and outcomes. Where possible, meta-analyses will be conducted by fitting hierarchical models for diagnostic accuracy and random effects models for clinical and cost-effectiveness estimates. Subgroup analyses are proposed to quantify the effect of variables such as gender, ethnicity and type of troponin assay on the estimated parameters.
Ethical approval is not required. The results will be published in a peer-reviewed journal and presented at international conferences.
This protocol is registered with PROSPERO, the International Prospective Register of Systematic Reviews, under the ID CRD42024533117. Any future amendments will be updated in the PROSPERO record.
胸痛是紧急救护车出诊的主要原因，常与急性心肌梗死（AMI）相关，这是一种需要立即住院治疗的危急病症。目前的诊断方法，如病史采集和心电图检查，存在局限性，尤其是对于非ST段抬高型心肌梗死。高敏心肌肌钙蛋白（cTn）检测在诊断上更具敏感性，但缺点是需要在医院进行检测，这可能会延迟诊断和必要的治疗方案。另一方面，即时检测cTn速度更快，且在更接近患者的地方进行；因此，在诊断准确性、临床实用性和相关安全性方面，它可能会从根本上改变院前护理路径。
提出一项系统评价和荟萃分析方案，以评估在院前环境中，为出现心脏性胸痛的成人排除AMI时，即时检测（POC）肌钙蛋白检测（无论有无临床决策辅助工具）的诊断准确性、临床实用性和安全性。
本方案遵循《英国医学杂志》指南，并遵守2015年系统评价和荟萃分析方案的首选报告项目报告标准。它已在国际前瞻性系统评价注册库PROSPERO（注册号：CRD42024533117）注册。全面的检索策略将在MEDLINE、EMBASE和CINAHL中识别相关研究，重点关注2000年以来的文献。纳入标准包括怀疑患有AMI的胸痛成人，不包括ST段抬高型心肌梗死患者。主要目标是1型AMI，次要结局包括30天时的主要不良心脏事件。将使用诊断准确性研究质量评估第2版、偏倚风险2和干预性非随机研究中的偏倚风险等工具进行偏倚风险评估，同时将使用综合卫生经济评价报告标准（CHEERS）清单评估经济评价的质量。提取的数据项将包括患者人口统计学信息、检测特征和结局。在可能的情况下，将通过拟合诊断准确性的分层模型和临床及成本效益估计的随机效应模型进行荟萃分析。建议进行亚组分析，以量化性别、种族和肌钙蛋白检测类型等变量对估计参数的影响。
无需伦理批准。研究结果将发表在同行评审期刊上，并在国际会议上展示。
PROSPERO注册号：本方案已在国际前瞻性系统评价注册库PROSPERO注册，注册号为CRD42024533117。未来的任何修订将在PROSPERO记录中更新。
