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首页> 外文期刊>Trials >Magnetic resonance Adenosine perfusion imaging as Gatekeeper of invasive coronary intervention (MAGnet): study protocol for a randomized controlled trial
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Magnetic resonance Adenosine perfusion imaging as Gatekeeper of invasive coronary intervention (MAGnet): study protocol for a randomized controlled trial

机译：磁共振腺苷灌注成像作为有创冠状动脉介入治疗（MAGnet）的守护者：一项随机对照试验的研究方案

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Background Current guidelines for the diagnosis and management of patients with stable coronary artery disease (CAD) recommend functional stress testing for risk stratification prior to revascularization procedures. Cardiac magnetic resonance imaging (CMR) is a modality of choice for stress testing because of its capability to detect myocardial ischemia sensitively and specifically. Nevertheless, evidence from randomized trials evaluating a CMR-based management of stable CAD patients in comparison to a more common angiography-based approach still is limited. Methods/design Patients presenting themselves with symptoms indicating a stable CAD and a class I or IIa indication for diagnostic coronary angiography are prospectively screened and enrolled in the study. All subjects receive a basic cardiological work-up and guideline-directed medical therapy. A 1:1 randomization in two groups is being performed. Patients in group 1 undergo diagnostic coronary angiography and subsequent revascularization according to current guidelines. Subjects in group 2 undergo adenosine stress CMR and in case of myocardial ischemia are sent to coronary angiography. Follow-up is planned for 3?years. During this time, the number of primary endpoints (defined as cardiac death and non-fatal myocardial infarction) and unplanned invasive procedures will be documented. Furthermore, symptom burden and quality of life will be assessed by use of the Seattle Angina Questionnaire. Sample size is calculated to prove non-inferiority of the CMR-based approach. Discussion In case this study is able to accomplish its aim to prove non-inferiority of the CMR-based management in patients with stable CAD; the importance of this emerging modality may further increase. Trial registration ClinicalTrials.gov, identifier: NCT02580851 . Registered on 14 October 2015. Unique Protocol ID: 237/11
机译：背景技术当前关于稳定型冠状动脉疾病（CAD）患者的诊断和治疗指南建议在进行血运重建之前对功能性压力测试进行风险分层。心脏磁共振成像（CMR）是压力测试的一种选择方式，因为它具有灵敏且特异性地检测心肌缺血的能力。然而，与比较常见的基于血管造影的方法相比，评估基于CMR的稳定CAD患者治疗的随机试验证据仍然有限。方法/设计前瞻性筛选出表现出症状的患者，这些患者表现出稳定的CAD症状以及用于诊断性冠状动脉造影的I级或IIa级适应症。所有受试者均接受基本的心脏病检查和指导性药物治疗。两组进行1：1随机化。第一组的患者根据当前指南接受了诊断性冠状动脉造影和随后的血运重建。第2组中的受试者进行腺苷应激CMR，如果发生心肌缺血，则进行冠状动脉造影。计划随访3年。在这段时间内，将记录主要终点（定义为心源性死亡和非致命性心肌梗塞）和计划外的侵入性手术的数量。此外，将通过西雅图心绞痛问卷调查评估症状负担和生活质量。计算样本量以证明基于CMR的方法不逊色。讨论如果本研究能够实现其目的，以证明稳定CAD患者基于CMR的管理不逊色;这种新兴形式的重要性可能会进一步提高。试用注册ClinicalTrials.gov，标识符：NCT02580851。 2015年10月14日注册。唯一协议ID：237/11

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