xSPECT-based Myocardial Perfusion Scintigraphy: Consistency of Functional Values and Feasibility of Myocardial Uptake Quantitation in Patients With Suspected Coronary Artery Disease (xSPECT MPI Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Absolute flow quantification (assessed by PET/CT)
研究概览
简要总结
This study is to evaluate the feasibility of myocardial Standardized Uptake Volume (SUV) assessment by means of X- (Single photon emission tomography) SPECT/Computed tomography (CT), to assess normal reference value under rest and stress in a homogeneous population without Coronary Artery Disease (CAD) and to assess the variation of absolute quantitative SUV measurements under rest and stress. The values will be evaluated in comparison with perfusion Positron Emission Tomography (PET)/CT (using 82Rb as perfusion tracer) and CT coronary angiography (CTCA) with contrast medium.).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Referral to non-invasive nuclear ischemia test as part of clinical care
- •Suspected coronary artery disease based on clinical symptoms
- •Informed Consent as documented by signature
排除标准
- •Pregnancy
- •Allergy against adenosine
- •Allergy against iodinated contrast medium
- •Recent myocardial infarction (<1 month)
- •Previous history of coronary revascularization
- •Severe asthma
- •Thyroid hyperfunction
- •atrioventricular block (AV) Block > I grade
- •Arrhythmic cardiopathy
- •Weight >101 Kg.
- •Acute or chronic renal impairment defined as Serum-Creatinine: above 1.5x upper limit of normal (ULN) and/or glomerular filtration rate (GFR) < 30 ml/min
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- •Participation in another study with investigational drug within the 30 days preceding and during the present study,
- •Enrolment of the investigator, his/her family members, employees and other dependent persons,
- •Claustrophobia
- •Intake of caffeine <24 Hours before the first day of examination
- •Enrolment into another study using ionizing radiation within the previous 12 months.
结局指标
主要结局
Absolute flow quantification (assessed by PET/CT)
时间窗: 60 minutes at Day 1
Consistency of quantitative parameters assessed by xSPECT compared to the "gold standard" which includes absolute flow quantification (assessed by PET/CT). The feasibility of myocardial SUV assessment by means of X-SPECT/CT will be tested by correlating the automatically calculated values with automatically calculated, PET-derived absolute blood flows. Rationale: values of quantified myocardial uptake are expected to be reliable the more they correlate with absolutely quantified myocardial blood flow in the myocardium, given the expected proportionality between uptake and subtending coronary blood flow.
presence of significant coronary stenoses (CTCA)
时间窗: 120 minutes at Day 2
Consistency of quantitative parameters assessed by xSPECT compared to the "gold standard" which includes the presence of significant coronary stenoses (CTCA). Normal reference values under rest and stress in a homogeneous population without CAD will be evaluated in comparison with perfusion 82Rb-PET/CT and CT coronary angiography (CTCA) with contrast medium. Rationale: a coronary artery disease can be ruled out in patients with normal 82Rb-PET and without detectable stenoses on CTCA, thus identifying a subpopulation of normal patients, wherein reference normal values can be provided.
次要结局
- Comparison of PET/CT, standard Myocardial perfusion SPECT (MPS) and new quantitative 99mTc-sestamibi xSPECT/quantitative computerized tomography (QCT) in the same patient(one point assessment after interventions at day 2)
- Interobserver variability of qualitative and quantitative assessments(one point assessment after interventions at day 2)
- Determination of uptake patterns that are suggestive for CAD(one point assessment after interventions at day 2)
- Quantitative 99mTC-sestamibi uptake values of the whole myocardium(one point assessment after interventions at day 2)
- Interobserver variability of all imaging modalities(one point assessment after interventions at day 2)