Bicuspid Valve Aortopathy: Feasibility of a Comparative Effectiveness Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 6
- 主要终点
- Change in aortic area measured by MRI
研究概览
简要总结
In order to determine the effectiveness of medical therapy options to prevent enlargement of the aorta in patients with a bicuspid aortic valve, a randomized study will be planned. This feasibility study will gather accurate data on number needed to screen, changes in medication use over time, and variance of the intended study endpoint.
详细描述
The study will consider all patients with a bicuspid aortic valve and 1) determine the number of patients needed to be screened for a clinical trial, based on patient eligibility percentages applying specific inclusion and exclusion criteria, 2) for those meeting these criteria, follow changes in and compliance with medical therapy over two years, and 3) in a limited subset of eligible patients, perform MRI at baseline and after 2 years to measure the change in aortic area over time.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Bicuspid aortic valve
- •Aortic measurement of 35 - 49 mm on prior imaging study
排除标准
- •Prior aortic valve or thoracic aortic surgery
- •Prior aortic dissection
- •Other condition associated with enlarged aorta including Coarctation, Marfans, Turner syndrome, Loeys-Dietz, etc.
- •Severe aortic stenosis or regurgitation
- •Contraindication to MRI such as claustrophobia or implanted pacer/defibrillator
- •Anticipated pregnancy, surgery, or move outside the area within 2 years
结局指标
主要结局
Change in aortic area measured by MRI
时间窗: 24 months
Patients will have a baseline and follow up MRI per a specific protocol to measure area of the ascending thoracic aorta. All measurements will be performed by a core imaging lab
次要结局
- Clinical events involving the aorta, including change in medical therapy(24 months)
研究者
Craig Broberg
Associate Professor
Oregon Health and Science University