Department of Cardiology, Gødstrup Hospital, Herning, Denmark.
Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.
Open Heart. 2023 Jul;10(2). doi: 10.1136/openhrt-2023-002328.
Current guideline recommend functional imaging for myocardial ischaemia if coronary CT angiography (CTA) has shown coronary artery disease (CAD) of uncertain functional significance. However, diagnostic accuracy of selective myocardial perfusion imaging after coronary CTA is currently unclear. The Danish study of Non-Invasive testing in Coronary Artery Disease 3 trial is designed to evaluate head to head the diagnostic accuracy of myocardial perfusion imaging with positron emission tomography (PET) using the tracers Rubidium (Rb-PET) compared with oxygen-15 labelled water PET (O-water-PET) in patients with symptoms of obstructive CAD and a coronary CT scan with suspected obstructive CAD.
This prospective, multicentre, cross-sectional study will include approximately 1000 symptomatic patients without previous CAD. Patients are included after referral to coronary CTA. All patients undergo a structured interview and blood is sampled for genetic and proteomic analysis and a coronary CTA. Patients with possible obstructive CAD at coronary CTA are examined with both Rb-PET, O-water-PET and invasive coronary angiography with three-vessel fractional flow reserve and thermodilution measurements of coronary flow reserve. After enrolment, patients are followed with Seattle Angina Questionnaires and follow-up PET scans in patients with an initially abnormal PET scan and for cardiovascular events in 10 years.
Ethical approval was obtained from Danish regional committee on health research ethics. Written informed consent will be provided by all study participants. Results of this study will be disseminated via articles in international peer-reviewed journal.
NCT04707859.
如果冠状动脉 CT 血管造影（CTA）显示出具有不确定功能意义的冠状动脉疾病（CAD），则目前的指南建议对心肌缺血进行功能成像。然而，目前尚不清楚 CT 冠状动脉成像后选择性心肌灌注成像的诊断准确性。丹麦非侵入性冠状动脉疾病 3 期试验研究旨在评估正电子发射断层扫描（PET）使用放射性示踪剂 Rubidium（Rb-PET）与氧-15 标记水 PET（O-water-PET）对头对头诊断疑似阻塞性 CAD 的冠状动脉 CT 扫描伴有 CAD 症状的患者的心肌灌注成像的准确性。
这是一项前瞻性、多中心、横断面研究，将包括约 1000 名有症状但无既往 CAD 的患者。在转诊进行冠状动脉 CTA 后，患者将被纳入研究。所有患者均接受结构化访谈和血液采样，进行基因和蛋白质组分析以及冠状动脉 CTA。在冠状动脉 CTA 上怀疑有阻塞性 CAD 的患者，将接受 Rb-PET、O-water-PET 和有创冠状动脉造影检查，测量三血管血流储备分数和冠状动脉血流储备的热稀释测量值。入组后，将使用西雅图心绞痛问卷对患者进行随访，并对首次 PET 扫描异常的患者进行随访 PET 扫描，随访时间为 10 年。
丹麦区域健康研究伦理委员会已批准该研究。所有研究参与者都将提供书面知情同意书。该研究的结果将通过国际同行评议期刊上的文章进行传播。
NCT04707859。
