Assessment With Cardiac Computed Tomography Angiography (CCTA) and Magnetic Resonance Imaging (MRI) in Asymptomatic Patients With Type 2 Diabetes for Detection of Unrecognized Myocardial Scar in Subclinical Coronary Atherosclerosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Guerbet
- 入组人数
- 351
- 试验地点
- 1
- 主要终点
- Prevalence of Occult Myocardial Scar on Delayed-enhanced MRI in Asymptomatic Patients With Type 2 Diabetes Mellitus
研究概览
简要总结
The study aimed to prospectively investigate the prevalence of myocardial scar on Dotarem-enhanced Cardiovascular Magnetic Resonance Imaging (MRI) in asymptomatic patients with type-2 Diabetes Mellitus and to assess its correlation with subclinical coronary artery disease on Cardiac Computed Tomography Angiography (CCTA).
详细描述
Patients underwent a cardiac MRI examination with Dotarem within 60 days after screening visit. The myocardial CCTA examination with Xenetix 350 was performed within 1 to 30 days (but no sooner than 24 hours) after the MRI examination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with onset of type 2 diabetes occurred at age 30 years or older
- •Patient between the ages of 50 and 75 years at enrolment time
- •Patient with at least two identified cardiac risk factors who will undergo a CMR and a CCTA examinations to evaluate his/her coronary and cardiac status
排除标准
- •Patient with angina pectoris or chest discomfort
- •Patient with stress test or invasive coronary angiography within the prior 3 years
- •Patient with history of myocardial infarction, overt non compensated heart failure, or coronary revascularization
- •Patient with hemodynamic instability.
- •Patient with a contraindication or intolerance to Beta-Blocker administration
研究组 & 干预措施
Dotarem and Xenetix 350
干预措施: iobitridol (Drug)
Dotarem and Xenetix 350
干预措施: gadoterate meglumine (Drug)
结局指标
主要结局
Prevalence of Occult Myocardial Scar on Delayed-enhanced MRI in Asymptomatic Patients With Type 2 Diabetes Mellitus
时间窗: From 1 week to 2 months (after the collection of data corresponding to cardiac MRI and CCTA examinations)
次要结局
- Number of Patients With and Without Occult Myocardial Scar on Cardiac MRI According to the Degree of Stenosis(From 1 week to 2 months (after the collection of data corresponding to cardiac MRI and CCTA examinations))