Prospective Registry of Patients Undergoing Cardiac CT With NAEOTOM Alpha Photon Counting-detector CT Before Transcatheter Aortic Valve Implantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 7
- 主要终点
- Diagnostic Accuracy of Ultra-High Resolution Photon-Counting Detector Coronary Computed Tomography Angiography (UHR PCD-CT CCTA)
研究概览
简要总结
The clinical and demographic characteristics of patients undergoing transcatheter aortic valve implantation (TAVI) pose unique challenges for coronary computed tomography (CT) imaging, as this patient population is mainly composed of elderly, frail individuals with severe aortic stenosis, multiple comorbidities, high prevalence of heavily calcified coronary artery disease (CAD) and revascularized coronary arteries. Such vulnerable patients could benefit from a more precise assessment and characterization of their CAD with ultra-high resolution (UHR) photon-counting detector (PCD) CT that would potentially avoid the need for pre-implantation invasive coronary angiography (ICA). This international multicenter prospective registry study aims to investigate the feasibility and diagnostic accuracy of PCD-CT in the assessment of CAD in the high-risk population of patients undergoing TAVI, as compared to ICA.
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
- •Clinically indicated TAVI
- •Clinically indicated CT and invasive coronary angiography
- •There are no contraindications to CT angiography.
- •Understanding and signing the consent form
排除标准
- •Pregnancy or breastfeeding
- •Chronic renal failure (eGFR <30 ml/m2)
- •Active oncological treatment
- •Any condition for which TAVI is contraindicated and therefore no prior radiological investigation of TAVI is indicated
结局指标
主要结局
Diagnostic Accuracy of Ultra-High Resolution Photon-Counting Detector Coronary Computed Tomography Angiography (UHR PCD-CT CCTA)
时间窗: through study completion, an average of 2 years
Assessment of the diagnostic accuracy (sensitivity, specificity, PPV, NPV) of UHR PCD-CT coronary angiography as compared to invasive coronary angiography (ICA) within three months of PCD-CT
次要结局
- Image Noise Analysis Across Reconstruction Parameters(through study completion, an average of 2 years)
- Correlation of Image Noise and Body Mass Index(through study completion, an average of 2 years)
- Correlation of Image Noise and Heart Rate(through study completion, an average of 2 years)
- Contrast-to-Noise Ratio (CNR) Analysis Across Reconstruction Parameters(through study completion, an average of 2 years)
- Vessel Sharpness Analysis Across Reconstruction Parameters(through study completion, an average of 2 years)
- Blooming Analysis Across Reconstruction Parameters(through study completion, an average of 2 years)
- Subjective Image Quality Analysis(through study completion, an average of 2 years)
- Correlation of Quantitative Coronary Artery Disease Assessment(through study completion, an average of 2 years)
- Correlation of Quantitative In-Stent Restenosis Assessment(through study completion, an average of 2 years)
- Correlation of Fractional Flow Reserve Measurement(through study completion, an average of 2 years)
- Quantitative Assessment of Plaque Composition(through study completion, an average of 2 years)
- Correlation of Plaque Composition(through study completion, an average of 2 years)
- Quantitative Assessment of Extracellular Volume Fraction(through study completion, an average of 2 years)
- Analysis of Structured Coronary Artery Disease Reporting in UHR PCD-CT(through study completion, an average of 2 years)
- Correlation of Quantitative UHR PCD-CT CCTA Parameters with Ischemia Imaging Tests(through study completion, an average of 2 years)
- Correlation of Quantitative UHR PCD-CT CCTA Parameters with Other Imaging Tests(through study completion, an average of 2 years)
- Correlation Between PCAT Attenuation and CT-derieved or Clinical Parameters(from inclusion up to a maximum follow-up period of 5 years)
- Correlation Between EAT Attenuation and CT-derieved or Clinical Parameters(from inclusion up to a maximum follow-up period of 5 years)
- Lung Water Density Quantification(through study completion, an average of 2 years)
- Assessment of Whole Body Extracellular Volume(through study completion, an average of 2 years)
- Major Adverse Cardiac Events(from inclusion up to a maximum follow-up period of 5 years)
- Extended Major Adverse Cardiovascular Events(from inclusion up to a maximum follow-up period of 5 years)
- Prosthesis Function Evaluation(from inclusion up to a maximum follow-up period of 5 years)
- Cost-effectiveness(from inclusion up to a maximum follow-up period of 5 years)
研究者
Prof. Maurovich-Horvat Pál
PhD, MPH, DSc, Director of Medical Imaging Centre, Chairman of Radiology
Semmelweis University