Spectral and Ultra High Resolution CT Systems for Non-Invasive Detection of Myocardial Ischemia: Stress CT Perfusion VS. FFR-CT
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- Diagnostic accuracy of CCTA, CCTA plus FFR-CT, and CCTA plus spectral stress CT perfusion in the detection of hemodynamically relevant coronary stenosis
研究概览
简要总结
Coronary artery disease (CAD) is the leading cause of mortality and morbidity worldwide. Coronary Computed Tomography angiography (CCTA) gained a pivotal clinical role for excellent sensitivity in rule-out CAD, but has limited specificity for a tendency to overestimate stenoses and for the lack of information about their hemodynamic impact. Fractional Flow Reserve derived from CT (FFR-CT) and stress CT perfusion (CTP) have been recently proposed to complement CCTA in the non-invasive assessment of myocardial ischemia, increasing the specificity and avoiding unnecessary catheterization. However, on energy-integrating (EID)-CT, FFR-CT has suboptimal performance, while CTP is affected by high radiation exposure. Both these approaches may benefit by the introduction of the new Photon Counting Detector (PCD)-CT technology, but data completely lacks. Aim of the study is to assess the performance of PCD-CT in the identification of significant CAD combining CCTA with FFR-CT and spectral 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
- •Patient referred to our hospitals for elective CCTA for ruling out CAD
- •CCTA evidence of moderate stenosis (50-69%) requiring functional assessment according to ESC guidelines
排除标准
- •hemodynamically unstable conditions,
- •previous revascularization,
- •myocardial infarction,
- •obesity (BMI>40 kg/m2),
- •renal insufficiency (GFR<30 mL/min),
- •atrial fibrillation or other significant arrhythmias; and
- •other overt cardiovascular diseases affecting CTP performance (e.g., heart failure, severe valvular regurgitation),
- •pregnancy and breastfeeding,
- •contraindications to iodinated contrast agents or regadenoson.
结局指标
主要结局
Diagnostic accuracy of CCTA, CCTA plus FFR-CT, and CCTA plus spectral stress CT perfusion in the detection of hemodynamically relevant coronary stenosis
时间窗: 36 months
CCTA-derived stenosis and plaque characterization; CT-FFR values from commercial and in-house solutions; CTP-derived iodine uptake measurement; invasive FFR as reference standard. Comparison of off-site versus on-site CT-FFR solutions determined against invasive FFR.
Evaluation of rest spectral CT perfusion for the assessment of haemodynamic significance of stenosis
时间窗: 36 months
Coronary stenosis severity at CCTA; myocardial iodine uptake at baseline, rest, and stress CTP; diagnostic performance of iodine uptake values against invasive FFR.
Identification of geometric features from PCD-CT ultra high resolution CCTA associated to plaque-specific ischemia at invasive FFR.
时间窗: 36 months
Blinded analysis of baseline CCTA for qualitative and quantitative plaque characteristics, with correlation to invasive FFR. Inter-rater agreement assessment between two expert readers. Deep learning-based radiomic feature extraction from plaques and vessel walls. Development of a data-driven feature selection pipeline to predict hemodynamically significant stenosis from CCTA data, using invasive FFR as reference.
次要结局
未报告次要终点
研究者
Anna Palmisano
MD, PhD
IRCCS San Raffaele