Utility of Regadenoson Low-dose Dynamic Computed Tomography for Myocardial Perfusion Assesment (ULYSSES Study).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Evaluation of feasibility of regadenoson low - dose dynamic computed tomography perfusion protocol.
研究概览
简要总结
The ULYSSES study is a single-center, prospective study aimed at evaluation of myocardial ischemia using regadenoson low-dose dynamic computed tomography myocardial perfusion imaging (CTP) in patients diagnosed with intermediate coronary artery stenoses in referrence to the magnetic resonance myocardial perfusion imaging (MR MPI).
详细描述
The ULYSSES study is a single-center, prospective study aimed at evaluation of myocardial ischemia using regadenoson low-dose dynamic computed tomography myocardial perfusion (CTP) in patients diagnosed with intermediate coronary artery stenoses in referrence to the magnetic resonance myocardial perfusion imaging (MR MPI).
The main objectives of the study are:
- to evaluate feasibility of low - dose regadenoson dynamic computed tomography myocardial imaging protocol
- to assess the diagnostic value of quantitative dynamic CTP based absolute parameters (myocardial blood flow - MBF, myocardial blood volume - MBV, perfused capillary blood volume - PCBV, peak value - PV, time to peak - TTP) in reference to magnetic resonance myocardial perfusion imaging
- to assess the diagnostic value of quantitative dynamic CTP based relative parameters (relative myocardial blood flow - MBFR, relative myocardial blood volume - MBVR, relative perfused capillary blood volume - PCBVR, relative peak value - PVR, relative time to peak - TTPR) in reference to magnetic resonance myocardial perfusion imaging
- evaluation of safety of regadenoson low-dose dynamic CTP.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age over 18 years
- •signing written, informed consent by the patient for participation in the study
- •patients who are asymptomatic or with symptoms of stable coronary heart disease
- •intermediate coronary artery stenosis of at least one coronary artery in CTCA
排除标准
- •the symptoms of unstable ischemic heart disease and /or myocardial infarction,
- •the history of myocardial infarction
- •patients with impaired renal function (GFR <60 mL)
- •contraindications for computed tomography or magnetic resonance imaging (including pregnancy, the presence of a cardiac pacemaker or cardioverter-defibrillator, claustrophobia, the presence of metal elements, etc.);
- •contraindications to the administration of iodine contrast media (including allergy to contrast, unstable hyperthyroidism, etc.)
- •contraindications to administration of regadenosone (hypersensitivity to the active substance, second or third degree atrioventricular block or other sinus node dysfunction, unstable angina, hypotension, decompensated heart failure, etc.);
- •heart failure with impaired left ventricular systolic function
- •a significant valvular heart disease
- •presence of aortic aneurysm or aortic dissection
- •persistent atrial fibrillation / atrial flutter
- •hypertrophic cardiomyopathy
结局指标
主要结局
Evaluation of feasibility of regadenoson low - dose dynamic computed tomography perfusion protocol.
时间窗: 24 months
Evaluation of the quality of CTP images asessed by experienced readers.
Assessment of ischemia in regadenoson low-dose dynamic CTP in reference to magnetic resonance myocardial perfusion imaging (MR MPI).
时间窗: 24 months
The presence of ischemia in CTP per myocardial segment.
次要结局
未报告次要终点