NCT02399852撤回不适用
Effects of Lomitapide on Carotid and Aortic Atherosclerosis in Patients Treated With Lomitapide in Usual Care (CAPTURE)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- The percent change from baseline in cartoid vessel wall area at the two-year evaluation
研究概览
简要总结
Study to assess changes in carotid and aortic atherosclerosis in patients being treated with lomitapide.
详细描述
This is a multi-center long-term open-label non-comparative study to assess changes in carotid and aortic atherosclerosis in patients being treated with lomitapide. Patients from countries in the EU, the US and Canada who are being treated with lomitapide and are enrolled in The Lomitapide Observational Worldwide Evaluation Registry (LOWER), will be invited by the LOWER enrolling physician to participate in this substudy.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Adult patients (age ≥18 years) who are enrolled in LOWER
排除标准
- •Patients with a prior history of carotid angioplasty, carotid stenting, or carotid atherectomy
- •Patients with a contraindication to MRI examination (i.e., brain aneurysm, implanted neural stimulator, implanted cardiac pacemaker, pacemaker wires or defibrillator, prosthetic heart valves, cochlear implant, ocular foreign body, or other implanted body)
- •Patients who have undergone a coronary stenting procedure in the preceding three weeks prior to enrollment
- •Patients prone to claustrophobia or known anxiety disorders that will interfere with the ability to acquire quality MRI scans
- •Patients with an implanted insulin pump
- •Patients with metal shrapnel or bullet wounds
- •Patients with a body mass index (BMI) > 40 kg/m2 (since it may be difficult to position comfortably with the MRI scanner)
- •Patients who work with metal lathes (unless an orbit x-ray performed prior to the enrollment MRI scan has been done to rule out metal fragments in the eye)
结局指标
主要结局
The percent change from baseline in cartoid vessel wall area at the two-year evaluation
时间窗: 2 years
次要结局
- The percent change from baseline to one and five years on therapy for carotid and aortic vessel wall area, and carotid and aortic vessel wall thickness.(5 Years)
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