Evaluation the Diagnostic Efficacy of a Low-dose Radiation and Contrast Agent Exposure Protocol for Coronary Computed Tomography Angiography(CTA)on Coronary Artery Disease in Diabetic Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- diagnosis accuracy (including sensitivity,specificity of the low-dose radiation and contrast agent exposure protocol for coronary CTA)
研究概览
简要总结
To assess diagnostic accuracy,image quality and renal safety of a double low-dose coronary CTA protocol at coronary artery evaluation in patients with diabetes by using invasive coronary angiography(ICA) as the reference method and to compare the results with those obtained traditional dose protocol. The study will randomly include about 400 consecutive participants aged 18 to 80 years old who had been diagnosed with diabetes and suspected coronary artery disease.All participants undergo ICA and coronary CT angiography performed with a whole-heart CT scan.Coronary segment interpretability,image quality based on a four-point Likert scale,blood indicators of renal function will be accessed between double low-dose CTA protocol and traditional CTA protocol. Investigators hypothesize that an individualized coronary CTA protocol that appropriately reduces radiation dose and contrast dose does not affect image quality and diagnostic accuracy, and can reduce the risk of kidney damage in high-risk patients.
详细描述
The study has been approved by the local ethics committee and allparticipants will be provided written informed consent. Iodixanol 320 mg/ml is injected followed by 30 ml of saline solution.In the test group,the tube voltage,contrast agent volume and flow rate are adapted to cardiac ejection fraction(EF) and body mass index(BMI)according to the pretest. participants in the contract group are injected 50 ml contrast agent with the flow rate of 5 ml/s in tube voltage of 120 kVp. All participants are scanned in automatic tube current.
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
- Double (Participant, Outcomes Assessor)
盲法说明
This study belongs to a diagnostic test of CT angiography . All participants use the same contrast agent. The interventions on the two groups are different in scanning protocol of CTA. The examinees and image readers are blind, and the scanning technician is unblinded.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 18 years old and ≤ 80 years old;
- •patients who have previously diagnosed diabetes;
- •patients with suspected coronary artery disease and undergoing coronary CT angiography (CTA);
- •Subjects are fully informed and provided written informed consent.
排除标准
- •The exclusion criteria are pregnancy and lactation women or recent birth planners
- •patients with Iodine contrast agent contraindications (such as a history of severe allergy history with iodine contrast agents, hyperthyroidism, etc.)
- •patients with chronic kidney disease (Phase 4-5, eGFR <30 ml/min/1.73 m2)
- •patients who have undergone coronary stent implantation or coronary artery bypass surgery
- •patients who have received iodine contrast-related tests within 24 hours
- •participated in other clinical trials within 3 months
- •other circumstances that the investigator believes are not suitable for participation in the trial
结局指标
主要结局
diagnosis accuracy (including sensitivity,specificity of the low-dose radiation and contrast agent exposure protocol for coronary CTA)
时间窗: three years
Comparing with invasive coronary angiography,if the low-dose radiation and contrast agent exposure protocol for coronary CTA can detect significant（\>50%）stenosis.
次要结局
- kidney function(three years)
- image quality(three years)