Nilsson Staffan, Gabro Fade, Stertman Erik, Bernfort Lars, Fredrikson Mats, Henriksson Pontus, Johansson Peter, Kastbom Lisa, Kärner Köhler Anita, Lööf Johan, Mourad Ghassan, Olsson Eva, Valladares Carlos, Östgren Carl Johan, Sederholm Lawesson Sofia, Engvall Jan, Iredahl Fredrik
Department of Health, Medicine and Caring Sciences, Primary Health Care Center, Linköping University, Linköping, Sweden.
Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.
Trials. 2025 Jun 21;26(1):215. doi: 10.1186/s13063-025-08911-w.
This trial aims to assess the effectiveness of a novel diagnostic package in the investigation of symptomatic chronic coronary artery disease (CAD), with a focus on reducing the time to diagnosis and improving risk assessment, compared to the current standard investigation approach. The package investigation is comprised of combined single photon emission computed tomography (SPECT), echocardiography, coronary artery calcification (CAC) scoring, not previously evaluated in Sweden for individual cardiovascular prevention, and CadScore, an acoustic risk score. The standard investigation is comprised of exercise bicycle stress testing and echocardiography.
The trial involves patients with a pre-test probability > 15% for significant CAD referred from primary healthcare centers (PHCs) in Region Östergötland (population 471,241 in March 2023) in south-east Sweden. All the 47 PHCs of the region will be invited to participate and will, after approval, be cluster randomized into two groups: package investigation versus standard investigation. The primary outcome is a composite measure comprised of waiting time to invasive coronary angiography or communication of non-invasive myocardial ischemia investigation results. Secondary outcomes include major adverse cardiovascular events (MACE), cost per patient, signs of reversible ischemia on any test, radiation exposure, and adherence to prescribed cardioprotective drugs.
This trial addresses the urgent problem of chest pain and dyspnea assessment in primary care and aims to speed up diagnosis, reduce the need for specialist consultations, and potentially improve patient outcomes, with referral to SPECT directly from PHC in comparison with the widely used exercise test. The novel approach includes CAC scoring. Additionally, the utility of acoustic CadScore in reclassifying the risk of CAD is explored.
The trial was registered on March 11, 2023, at ClinicalTrials.gov with the identifier: NCT05782582.
本试验旨在评估一种新型诊断方案在有症状的慢性冠状动脉疾病（CAD）检查中的有效性，重点是与当前标准检查方法相比，减少诊断时间并改善风险评估。该方案检查包括联合单光子发射计算机断层扫描（SPECT）、超声心动图、冠状动脉钙化（CAC）评分（瑞典此前未针对个体心血管预防进行过评估）以及声学风险评分CadScore。标准检查包括运动自行车负荷试验和超声心动图。
该试验纳入了瑞典东南部东约特兰地区（2023年3月人口为471,241）初级医疗保健中心（PHC）转诊来的、重大CAD预测试概率>15%的患者。该地区所有47个PHC将被邀请参与，获批后将被整群随机分为两组：方案检查组与标准检查组。主要结局是一个综合指标，包括等待进行有创冠状动脉造影的时间或无创心肌缺血检查结果的传达时间。次要结局包括主要不良心血管事件（MACE）、每位患者的费用、任何检查中可逆性缺血的迹象、辐射暴露以及对规定心脏保护药物的依从性。
本试验解决了初级保健中胸痛和呼吸困难评估的紧迫问题，旨在加快诊断速度，减少专科会诊需求，并可能改善患者结局，与广泛使用的运动试验相比，可直接从PHC转诊至SPECT。这种新方法包括CAC评分。此外，还探讨了声学CadScore在重新分类CAD风险方面的效用。
该试验于2023年3月11日在ClinicalTrials.gov上注册，标识符为：NCT05782582。
