Buckert Dominik, Witzel Simon, Cieslik Maciej, Tibi Raid, Rottbauer Wolfgang, Bernhardt Peter
Department of Internal Medicine II, University of Ulm, Albert-Einstein-Allee 23, 89081, Ulm, Germany.
Heart Clinic Ulm, Ulm, Germany.
Trials. 2017 Jul 28;18(1):358. doi: 10.1186/s13063-017-2101-6.
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.
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.
ClinicalTrials.gov, identifier: NCT02580851 . Registered on 14 October 2015. Unique Protocol ID: 237/11.
目前关于稳定型冠状动脉疾病（CAD）患者诊断和管理的指南推荐在血运重建手术前进行功能负荷试验以进行危险分层。心脏磁共振成像（CMR）因其能够敏感且特异检测心肌缺血，是负荷试验的首选方式。然而，与更常见的基于血管造影的方法相比，评估基于CMR管理稳定型CAD患者的随机试验证据仍然有限。
方法/设计：前瞻性筛选并纳入有提示稳定型CAD症状且有I类或IIa类诊断性冠状动脉造影指征的患者。所有受试者均接受基本的心脏病学检查和指南指导的药物治疗。进行1:1随机分为两组。第1组患者根据现行指南接受诊断性冠状动脉造影及随后的血运重建。第2组患者接受腺苷负荷CMR检查，若存在心肌缺血则进行冠状动脉造影。计划随访3年。在此期间，记录主要终点事件（定义为心源性死亡和非致命性心肌梗死）的数量和非计划侵入性操作。此外，使用西雅图心绞痛问卷评估症状负担和生活质量。计算样本量以证明基于CMR方法的非劣效性。
如果本研究能够实现其证明基于CMR管理稳定型CAD患者非劣效性的目标，这种新兴方式的重要性可能会进一步增加。
ClinicalTrials.gov，标识符：NCT02580851。于2015年10月14日注册。唯一方案标识符：237/11。
