CT coronary angiography in patients with suspected angina due to coronary heart disease (SCOT-HEART): an open-label, parallel-group, multicentre trial
CT coronary angiography in patients with suspected angina due to coronary heart disease (SCOT-HEART): an open-label, parallel-group, multicentre trial
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DOI：
10.1016/s0140-6736(15)60291-4
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发表时间：
2015-06-13
期刊：
影响因子：
168.9
通讯作者：
Steedman, Tracey
中科院分区：
文献类型：
--
作者：
Newby, David;Williams, Michelle;Steedman, Tracey
CT冠状动脉造影（CTCA）在稳定性胸痛患者中的益处尚未得到系统研究。我们的目的是评估CTCA的诊断，管理和结果的患者提到的心脏科诊所怀疑心绞痛由于coronaryheartdisease.Methods在这个前瞻性开放标签，平行组，多中心试验，我们招募了年龄在18-75岁的患者，从12个心脏科胸痛诊所怀疑心绞痛由于冠心病的评估。我们将受试者随机（1：1）分配到标准治疗加CTCA或仅标准治疗组。通过基于网络的服务进行随机化，以确保分配隐藏。主要终点是6周时对继发于冠心病的心绞痛诊断的确定性。所有分析均为意向性治疗，患者在其分配的组中进行分析，而不考虑扫描依从性。该研究注册于ClinicalTrials.gov，编号NCT 01149590。结果在2010年11月18日至2014年9月24日期间，我们随机分配了9849例患者中的4146例（42%），这些患者被转诊评估疑似冠心病引起的心绞痛。47%的参与者基线临床诊断为冠心病，36%的参与者因冠心病而心绞痛。在6周时，CTCA对558例（27%）患者的冠心病诊断和481例（23%）患者的冠心病心绞痛诊断进行了重新分类（标准治疗22例[1%]和23例[1%]; p
Background The benefit of CT coronary angiography (CTCA) in patients presenting with stable chest pain has not been systematically studied. We aimed to assess the effect of CTCA on the diagnosis, management, and outcome of patients referred to the cardiology clinic with suspected angina due to coronary heart disease.Methods In this prospective open-label, parallel-group, multicentre trial, we recruited patients aged 18-75 years referred for the assessment of suspected angina due to coronary heart disease from 12 cardiology chest pain clinics across Scotland. We randomly assigned (1:1) participants to standard care plus CTCA or standard care alone. Randomisation was done with a web-based service to ensure allocation concealment. The primary endpoint was certainty of the diagnosis of angina secondary to coronary heart disease at 6 weeks. All analyses were intention to treat, and patients were analysed in the group they were allocated to, irrespective of compliance with scanning. This study is registered with ClinicalTrials.gov, number NCT01149590.Findings Between Nov 18, 2010, and Sept 24, 2014, we randomly assigned 4146 (42%) of 9849 patients who had been referred for assessment of suspected angina due to coronary heart disease. 47% of participants had a baseline clinic diagnosis of coronary heart disease and 36% had angina due to coronary heart disease. At 6 weeks, CTCA reclassified the diagnosis of coronary heart disease in 558 (27%) patients and the diagnosis of angina due to coronary heart disease in 481 (23%) patients (standard care 22 [1%] and 23 [1%]; p