Ultra Low Iodine Loaded Spectral CT Angiography (CTA) of the Aorta and Lower Limb: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Mean arterial attenuation
研究概览
简要总结
The objectives of this study are:
Evaluation of ultra-low iodine load CTA protocols of the aorta and lower extremities.
To investigate whether dual-layer in combination with with virtual monoenergetic imaging (VMI) allows for reduction of contrast medium (CM) in CTA of the aorta and lower limbs i with sustained objective and subjective image quality parameters.
详细描述
CT angiography (CTA) of the aorta and the lower limb is one of the most important tools for diagnostic, evaluation of the severity of the peripheral arterial disease, decision making, treatment planning and follow-up; but usually requires the use of iodine contrast medium.
Due to the high prevalence of renal impairment (eGFR < 90 ml/min/1.73m) in the elderly hospitalized population (more than 90% among inpatients aged over 60 years) contrast-medium-induced nephropathy is a major concern in this population.
The recently introduced spectral CT technique utilizes x-rays covering a spectrum of energy-levels as opposed to conventional CT in which x-rays are set to one specific energy level.
This technology offers many possibilities, such as "boosting" the x-ray contrast effect of iodine. This improves the vascular enhancement of the contrast medium using low-energy, virtual monoenergetic imaging (VNI).
The objectives of this study are:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
盲法说明
Participants are not informed of which arm they are assigned to.
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
- •Inpatients and outpatients with kidney function (eGFR) allowing for safe administration of standard contrast dose (as calculated with the OmniVis calculator).
- •Patients with clinical suspicion of disease of the aorta and/or arteries in the lower limb.
- •Referral to CTA diagnosis, treatment planning or follow-up.
排除标准
- •Iodine contrast medium allergy
- •Age < 18 years
- •Lack of informed consent
- •Critical ischemia of the lower extremities
研究组 & 干预措施
Half iodine - Spectral CT group
Patients receive half dosage of iodine contrast agent, and Spectral CT acquisition with Virtual Monoenergetic Images at 40 and 50 kiloelectronVolts (keV).
干预措施: Half iodine Spectral CT (Diagnostic Test)
Standard iodine - Conventional CT
Patients receive standard dosage of iodine contrast agent, and conventional 120 kiloVolts (kV) polychromatic CT images
干预措施: Standard iodine conventional CT (Diagnostic Test)
结局指标
主要结局
Mean arterial attenuation
时间窗: Measured on CT images acquired at time of inclusion
Attenuation (x-ray density) is measured in Hounsfield units (HU) digitally by placing a "region of interest" (ROI) circle in the Aorta, common iliac-, femoral- and popliteal arteries on the CT images acquired at the time of inclusion.
次要结局
- Subjective examination quality(Rated on CT images acquired at time of inclusion)
- Rate of diagnostic quality angiography(Measured on images acquired at time of inclusion)
研究者
Peter Maehre Lauritzen
Researcher, Radiologist, PhD
University Hospital, Akershus