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临床试验/NCT05497466
NCT05497466Unknown不适用

PUMCH Study Into Individualized Scanning for Coronary Artery Disease

Peking Union Medical College Hospital0 个研究点目标入组 300 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
主要终点
The diagnostic quality produced by individualized scan and injection protocol.

研究概览

简要总结

Cardiac computed tomographic angiography (CCTA) is a non-invasive diagnostic imaging technique for visualization of the coronary arteries and thus, frequently used in the evaluation of coronary artery disease (CAD). CT technology is improving continuously, and various technological advances not only increase diagnostic accuracy, but also provide a substantial reduction in radiation dose and scan acquisition time. These modifications challenge optimal synchronization and timing of scan protocols in CM administration due to a shorter data acquisition window, hereby creating opportunities for injection strategies with a decrease in total amount of contrast media (CM). [4-6] Reducing the radiation dose of CT angiography and injected CM dose have become a routine need and trend in clinical practice. In addition to this, physical factors such as cardiac output and body weight are considered important factors with regard to variability in vascular enhancement. A standard 'one size fits all' protocol with a standard injected CM volume, independent of weight and length of the patient has proven to be outdated and precision medicine in the future should be based on individually tailored scan and CM injection protocols that are more scientific and involve various parameters such as individual tube voltage, patients weight and heart rate to benefit patients by reducing radiation exposure and CM dose while fulfilling the diagnostic purpose.

Prospective studies focused on modifying both scan and injection parameters were completed in the Dutch (representing European) patient population with body weight varying between 40 and 130kg by Maastricht University Medical Center (MUMC) and have shown very promising results in Dutch population. In theory, these scan and injection protocols should be applicable to both average Dutch population (e.g. European population) and other heterogeneous patient populations, i.e. world-wide patient populations with any BMI category. However, so far, the effectiveness of this approach has not been deliberately discussed in the (on average) heavier North American population or the lighter Asian population. So, prior to promotion of the individually tailored CT scan protocols for global use, we need to obtain enough evidence in terms of the diagnostic confidence from those protocols in Chinese patients who could represent Asian population.

详细描述

Primary objective: To prospectively evaluate the diagnostic quality (including the intravascular attenuation of the coronary arteries and image quality) in a previously validated individualized scan and CM injection CCTA protocol whereas both scan and injection parameters are tailored to the individual patient in Chinese population.

Secondary Objective(s):

  1. To evaluate the radiation dose and contrast media dose of this individualized approach for CCTA in a Chinese patient population.
  2. To evaluate the injection parameters required for the average patient population.

Subjects will be screened according to clinical data and enrolled in the study after providing informed consent. Patients will be scanned by Siemens Force CT scanner, prospective ECG gate-control and narrow window scanning technology, as well as intelligent KV (CARE-KV Tech) scanning technology. The CARE-kV software will determine optimal scan parameters for each patient, without any human intervention. By this means, each patient will be included in a specific tube-voltage arm based on in the condition of individual patient.

Care kV is a software that collects information about the patient's own attenuation values/ x-ray absorption during a so-called scout scan. Based on these parameters and taking into account the required scan quality (e.g. parenchymal, bone or vascular), the software determines the optimal scan settings for the patient. This includes both a variable tube current (in mAs) along the z-axis of the patient and an individual tube voltage (in kV). The tube voltage can be selected between 70 and 150kV in steps of 10kV. For this study, the scan quality slider will be set to 'vascular' or '11', which is commonly used in clinical studies and clinical practice for CCTA.

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

入选标准

  • Age: Patient aged older than 18;
  • Deny previous cardiovascular history;
  • Atypical or typical complaints of angina and referred for CCTA to rule out CAD with Iopromide 370 mgI/ml by clinicians
  • Possibility of 'flash' mode scan: patient heart rate below 70 beats per minute and regular rhythm;
  • Patients or families are able to understand the study protocol and willing to participate in the study and provide written informed consent.

排除标准

  • Any contraindications for prospective ECG gate-control CT coronary angiography, including:
  • Inability to perform a breath hold for at least the expected scan time;
  • Unstable angina;
  • Hemodynamic instability;
  • Pregnant or lactating women;
  • Renal insufficiency (defined as eGFR<30 ml/min/1.73m2);
  • Previous history of adverse reactions to iodinated contrast agents;
  • Confirmed or suspected hyperthyroidism or pheochromocytoma;
  • Atrial fibrillation or arrhythmia; severe congestive heart failure (class IV according to NYHA classification of cardiac function);
  • History of CAD
  • Patients undergoing PCI before coronary CTA examination, or patients with a previous history of heart bypass surgery
  • Insufficient cannula venous access (preferred 18G, minimal 20G cannula);
  • Patients who are participating other clinical studies。

结局指标

主要结局

The diagnostic quality produced by individualized scan and injection protocol.

时间窗: 48 hours post examination

When using an individualized scan and injection protocol, definition of diagnostic quality of the scan is the imaging result could satisfy the following two criteria: 1. Intravascular attenuation of the target coronary arteries should be over 325 Hounsfield Units (HU). 2. Subjective overall image quality should be diagnostic (image quality \> 2 of a 5-point Likert scale).

次要结局

  • Objective evaluation on image quality(48 hours post examination)
  • Subjective evaluation on image quality(48 hours post examination)
  • contrast media dose in ml(During Injection procedure)
  • iodine delivery rate (IDR) in mgI/s(During Injection procedure)
  • contrast media flow rate in ml/s(During Injection procedure)
  • contrast media peak flow rate [ml/s](During Injection procedure)
  • Time-to-peak of contrast media [s](During Injection procedure)
  • Patient radiation dose:volume CT dose index (CTDIvol) in mGy(48 hours post examination)
  • Patient radiation dose: size-specific dose estimates (SSDEs) of chest in mGy(48 hours post examination)
  • Patient radiation dose: dose length product (DLP) in mGy*cm(48 hours post examination)
  • Patient radiation dose: effective dose (ED) in mSv(48 hours post examination)

研究者

申办方类型
Other
责任方
Sponsor

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