CT Myocardial Perfusion Imaging to Guide the Diagnosis and Treatment of Patients With Stable Coronary Artery Disease: a Randomized Controlled Study (POTENTIAL)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 660
- 试验地点
- 4
- 主要终点
- The rate of non-revascularization treatment of the two arms
研究概览
简要总结
The overall goal of this project is to compare the non-revascularization rate of coronary angiography in patients with stable coronary artery disease (CAD) within 90 days after CT myocardial perfusion imaging (CT-MPI) or Single-Photon Emission Computed Tomography myocardial perfusion imaging (SPECT-MPI), and 1-year major adverse cardiovascular events (MACE).
详细描述
Participants will be patients with proven coronary artery disease (CAD) who are scheduled randomized to undergo CT Myocardial Perfusion Imaging (CT-MPI) or Single-Photon Emission Computed Tomography myocardial perfusion imaging (SPECT-MPI) to evaluate myocardium ischemia. Those patients with positive myocardial ischemia will scheduled to undergo invasive coronary angiography (ICA), and those without myocardial ischemia will have optical medical therapy. The purpose of the study is to verify that CT-MPI guided clinical pathways are not inferior to SPECT-MPI pathways in downstream treatment decision making and safety assessment. In order to achieve this aim, the study team will compare the non-revascularization rate of ICA within 90 days after CT-MPI and SPECT-MPI. 1-year major adverse cardiovascular events (MACE) will be also compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Patients with stable chest pain who have undergone coronary CT angiography and have 50-90% stenosis in at least one vessel > 2mm in diameter
- •Able to provide signed informed consent
排除标准
- •Suspected or confirmed acute coronary syndrome
- •Evidence of clinical instability or need for an emergent procedure
- •History of percutaneous coronary stent implantation, history of coronary artery bypass grafting, or history of myocardial infarction
- •Left main artery stenosis ≥ 50%
- •Severe heart failure (New York Heart Association (NYHA) ≥III)
- •Estimated glomerular filtration rate < 60 mL/min/1.73 m2
- •Contraindicated to use contrast agents, beta-blockers, nitrates or adenosine drugs
- •Acute episodes of bronchial asthma or chronic obstructive pulmonary disease
- •II or III degree atrioventricular block
- •History of pacemaker or implantable cardioverter defibrillator implantation
- •Combined with other cardiovascular diseases including cardiomyopathy, congenital heart disease, valvular heart disease, pulmonary vascular disease, pericardial disease, etc
- •Pregnant or trying to be pregnant
- •Combined with any other serious disease, life expectancy <1 year
- •Any condition leading to possible inability to comply with the protocol procedures and follow-up
- •Currently participating in any other clinical trials
结局指标
主要结局
The rate of non-revascularization treatment of the two arms
时间窗: within 90 days after CT-MPI or SPECT-MPI examination
The incidence of conventional angiography not leading to revascularization within 90 days after CT-MPI or SPECT-MPI.
次要结局
- The rate of major adverse cardiovascular events of the two arms(One year after CT-MPI or SPECT-MPI)
- Difference in quality of Life of the two arms(One year after CT-MPI or SPECT-MPI)
- Difference in cost of the two arms(One year after CT-MPI or SPECT-MPI)
- Difference in cumulative radiation exposure dose of the two arms(Total cumulative radiation exposure dose during CT-MPI or SPECT-MPI and invasive coronary angiography within one year)
研究者
Bin Lu
Director of Radiologic Imaging
Chinese Academy of Medical Sciences, Fuwai Hospital