NCT05877768尚未招募不适用
PCD-CT Registry: Evaluation of Photon Counting Detector-CT Based Image Parameters in the Assessment and Quantification of Coronary Artery Disease (EPIPHANY)
University Medical Center Mainz1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2023年6月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Major Adverse Cardiac Events
研究概览
简要总结
The goal of this observational study is to learn about a new type of computed tomography (Photon-Counting Detector CT) in patients with coronary artery disease.
The main questions it aims to answer are:
- How good is the image quality for the new CT
- How accurate are measurements in the images of the new CT
- Is there a relationship between measurements in the images and the management of the disease (e.g. new medication or additional investigations)
- Is there a relationship between measurements in the images and the results of follow-up investigations
- Is there a relationship between measurements in the images and the patient outcome
Participants will undergo normal clinical assessment of coronary artery disease and all data from the CT scan and additional investigations will be collected. There will be no additional investigations for the purpose of the study. After 1, 2 and 5 years, participants will be asked to answer a health questionaire.
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
- •Clinical indication for a coronary computed tomography angiography (CCTA) for the suspicion of coronary artery disease or the progression thereof
- •Written informed consent
排除标准
- •Contraindications preventing the execution of the CCTA (e.g., pregnancy)
结局指标
主要结局
Major Adverse Cardiac Events
时间窗: From inclusion to a maximum follow-up of 5 years
Composite endpoint: major adverse cardiovascular event (MACE); defined as at least one of the following: cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke.
次要结局
- Subjective Image Noise of PCD-CCTA(during the PCD-CCTA examination)
- Objective Vessel sharpness in PCD-CCTA(during the PCD-CCTA examination)
- Subjective Image Quality in PCD-CCTA(during the PCD-CCTA examination)
- Quantitative analysis of Coronary Calcium Scoring from PCD-CCTA(during the PCD-CCTA examination)
- Subjective Vessel sharpness in PCD-CCTA(during the PCD-CCTA examination)
- Objective Image Quality in PCD-CCTA(during the PCD-CCTA examination)
- Influence of kernel sharpness level on quantitative parameters of the PCD-CCTA(during the PCD-CCTA examination)
- Correlation of quantitative PCD-CCTA parameters with the results of additional imaging ischemia tests(Imaging ischemia tests within 3 months of initial PCD-CCTA)
- Correlation of quantitative PCD-CCTA parameters with the results of additional other imaging tests(Imaging tests within 3 months of initial PCD-CCTA)
- Influence of slice thickness of reconstruction on image quality of the PCD-CCTA(during the PCD-CCTA examination)
- Influence of radiation dose on quantitative parameters of the PCD-CCTA(during the PCD-CCTA examination)
- Influence of the patients heart rate on quantitative parameters of the PCD-CCTA(during the PCD-CCTA examination)
- Influence of reconstruction kernel on image quality of the PCD-CCTA(during the PCD-CCTA examination)
- Influence of kernel sharpness level on image quality of the PCD-CCTA(during the PCD-CCTA examination)
- Influence of radiation dose on image quality of the PCD-CCTA(during the PCD-CCTA examination)
- Influence of the acquisition type on quantitative parameters of the PCD-CCTA(during the PCD-CCTA examination)
- Influence of the acquisition type on image quality of the PCD-CCTA(during the PCD-CCTA examination)
- Analysis of Stenosis Classification from PCD-CCTA(during the PCD-CCTA examination)
- Quantitative analysis of Coronary Diameter Stenoses from PCD-CCTA(during the PCD-CCTA examination)
- Quantitative analysis of Coronary Area Stenoses from PCD-CCTA(during the PCD-CCTA examination)
- Quantitative analysis of computed Fractional Flow Reserve from PCD-CCTA(during the PCD-CCTA examination)
- Rates of patients undergoing further cardiac diagnostics(2 weeks after initial PCD-CCTA, 1-year follow-up, 2-year follow-up and final follow-up up to a max of 5 years)
- Correlation and agreement of Percent diameter stenosis measurement from PCD-CCTA with Fractional Flow Reserve from ICA(ICA within 3 months of initial PCD-CCTA)
- Correlation and agreement of Plaque composition assessment from PCD-CCTA with intracoronary techniques(ICA within 3 months of initial PCD-CCTA)
- Quantitative analysis of myocardial density from PCD-CCTA(during the PCD-CCTA examination)
- Rates of patients undergoing cardiac interventions(2 weeks after initial PCD-CCTA, 1-year follow-up, 2-year follow-up and final follow-up up to a max of 5 years)
- Patient management(at baseline, 1-year follow-up, 2-year follow-up and final follow-up up to a max of 5 years)
- Correlation and agreement of quantitative measurements from PCD-CCTA with ICA(ICA within 3 months of initial PCD-CCTA)
- Correlation and agreement of non-invasive Fractional Flow Reserve from PCD-CCTA with invasive Fractional Flow Reserve from ICA(ICA within 3 months of initial PCD-CCTA)
- Quantitative analysis of myocardial iodine content from PCD-CCTA(during the PCD-CCTA examination)
- Quantitative analysis of extracellular volume fraction from PCD-CCTA(during the PCD-CCTA examination)
- Influence of BMI on quantitative parameters of the PCD-CCTA(during the PCD-CCTA examination)
- Influence of biological sex on quantitative parameters of the PCD-CCTA(during the PCD-CCTA examination)
- Influence of monoenergetic energy levels on quantitative parameters of the PCD-CCTA(during the PCD-CCTA examination)
- Analysis of occurrence in Major Adverse Cardiac Events in subgroups(at baseline, 1-year follow-up, 2-year follow-up and final follow-up up to a max of 5 years)
- Objective Assessment of Noise-Power Spectra of PCD-CCTA(during the PCD-CCTA examination)
- Influence of BMI on image quality of the PCD-CCTA(during the PCD-CCTA examination)
- Objective Image Noise of Photon-Counting Detector Coronary Computed Tomography Angiography (PCD-CCTA)(during the PCD-CCTA examination)
- Influence of biological sex on image quality of the PCD-CCTA(during the PCD-CCTA examination)
- Influence of monoenergetic energy levels on image quality of the PCD-CCTA(during the PCD-CCTA examination)
- Influence of the patients heart rate on image quality of the PCD-CCTA(during the PCD-CCTA examination)
- Influence of slice thickness of reconstruction on quantitative parameters of the PCD-CCTA(during the PCD-CCTA examination)
- Influence of reconstruction kernel on quantitative parameters of the PCD-CCTA(during the PCD-CCTA examination)
研究者
Tilman Emrich
Dr. med.
University Medical Center Mainz
研究点 (1)
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