Department of Radiology
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Vessel Attenuation
研究概览
简要总结
Extrinsic prewarming of iodinated CT contrast media (CM) to body temperature reduces viscosity and injection pressures. However, guideline recommendations on the necessity to prewarm iodinated CM are conflicting. And studies examining the effect of extrinsic warming CM for coronary CTA(CCTA) on clinical adverse events and image quality are lack.
Enrolled patients of chest pain or coronary artery disease screening were eligible for this a double-blinded, randomized noninferiority trial, and equally allocated into two group randomly: BBT-CM (basic body temperature) group received 37°C CM; RT-CM (room temperature) group received ~23°C CM. A state-of-the-art individualized CM (iopamidol at 370 mg I/mL) injection protocol was used, based on body weight.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Coronary symptomatic patients (i.e., chest pain).
- •Patients for Coronary artery disease screening
排除标准
- •Hemodynamic instability
- •Renal insufficiency (estimated glomerular filtration rate <30 mL/min per 1.73 m2)
- •Prior adverse reactions to iodinated CM
- •Age younger than 18 years
- •Inability to place an 18-gauge needle.
研究组 & 干预措施
BBT-CM (basic body temperature) group
BBT-CM (basic body temperature) group received contrast media warmed to body temperature (37°C[99°F]) before coronary CTA.
干预措施: Iopamidol (Drug)
RT-CM (room temperature) group
RT-CM (room temperature) group received contrast media at room temperature (~23°C [~73°F]) before coronary CTA.
干预措施: Iopamidol (Drug)
结局指标
主要结局
Vessel Attenuation
时间窗: Expected within one month after the coronary CTA is performed
Mean attenuation in Hounsfield Units (HU) is based on coronary bifurcation, preferably right coronary artery (RCA), left anterior descending artery (LAD), and left circumflex coronary artery (LCX)). Absolute difference in mean attenuation of coronary vessels between groups was calculated with a two-sided 95% confidence interval of the difference.
次要结局
- Allergic or allergiclike reaction(30 minutes after coronary CTA)
- Extravasations(Expected during the coronary CTA scan.)
- Objective image quality - Signal-to-noise ratio(SNR)(Within one month after the CT is performed)
- Objective image quality -Contrast-to-noise ratio(CNR)(Within one month after the CT is performed)
- CT Dose Index (CTDI)vol(Expected during the coronary CTA is performed)
- Physiologic reactions-Urgency desire(Immediately after CT)
- Body Mass Index(Right before the scan is performed)
- Subjective image quality(Within one month after the CT is performed)
- Heart rate(During the coronary CTA.)
- Flow rate(Within one month after the CT is performed)
- Dose-length product (DLP)(Within one month after the CT is performed)
研究者
Hao Wu
Associate professor
Chongqing Emergency Medical Center