CHANGE-MRI (CTEPH DIAGNOSIS Europe - MRI)
试验速览
- 阶段
- 3 期
- 入组人数
- 1,080
- 试验地点
- 2
- 主要终点
- The proportion of patients with positive MRI in the group of patients with negative VQ-SPECT who are negative in the gold standard
研究概览
简要总结
Phase III diagnostic trial to demonstrate that functional lung MRI can replace VQ-SPECT in a diagnostic strategy for patients with suspected CTEPH where positive findings are verified with catheter pulmonary angiography (CPA), or computed tomography pulmonary angiography (CTPA)
详细描述
CHANGE-MRI is a prospective, multicentre, comparative phase III diagnostic study. The study aims to show via an in-place validation that MRI can replace VQ-SPECT as a screening test for chronic pulmonary embolism in the diagnostic algorithm for CTEPH. The diagnostic gold standard is catheter pulmonary angiography (CPA) or computed tomography pulmonary angiography (CTPA) with correction from the clinical outcome after 6-12 months.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Transthoracic echocardiography indicates pulmonary hypertension
- •Patients with clinical suspicion for CTEPH, scheduled for SPECT
- •Provided informed consent for the study
- •Age >18y
排除标准
- •Patient unable to undergo MRI (e.g. due to claustrophobia, cardiac pacemaker, hypersensitivity to MR i.v. contrast imaging agents)
- •Women who are pregnant or breast feeding
结局指标
主要结局
The proportion of patients with positive MRI in the group of patients with negative VQ-SPECT who are negative in the gold standard
时间窗: 6 months
The proportion of patients with positive MRI in the group of patients who have a positive VQ-SPECT diagnosis for chronic pulmonary embolism and who are positive in the gold standard
时间窗: 6 months
次要结局
未报告次要终点