Prospective Treatment Algorithm Guiding Repair of Severe Ischemic Mitral Regurgitation: Canadian Mitral Research Alliance (CAMRA) 2 Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Left ventricle end-systolic volume indexed to body surface area
研究概览
简要总结
Ischemic mitral regurgitation is a disease where the mitral valve is regurgitant, or leaking, as a result of changes in the muscle of the heart caused by coronary artery disease Ischemic mitral regurgitation, or IMR, is normally treated by repairing or replacing the mitral valve. Currently, we don't have very strong evidence showing which patients might benefit from mitral valve repair and which might benefit from replacement, and surgeons tend to repair or replace valves based on their preference or experience. Some surgeons, including Dr. Vincent Chan, the Principal Investigator, believe that the decision to repair or replace the valve should be based on specific measurements of the mitral valve. This study will randomly assign patients to receive either the current standard of care for ischemic mitral regurgitation, which is valve repair or replacement based on the surgeon's preference, or to have their treatment decided by a set of criteria called an algorithm. This algorithm will assign patients with certain mitral valve measurements to repair, and others to replacement. Patients will be followed for 12 months after surgery, to compare whether patients whose treatment was decided by the algorithm did better than patients whose treatment was decided by surgeon preference.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Echocardiographic outcome assessment will be blinded.
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
- •Severe ischemic mitral valve regurgitation
- •18 years of age, and able to provide informed consent.
排除标准
- •Mixed mitral valve pathology
- •Acute ischemic mitral regurgitation
研究组 & 干预措施
Treatment algorithm
Mitral valve will be replaced if posterior leaflet tethering angle >=25 degrees.
Mitral valve will be repaired if posterior leaflet tethering angle <25 degrees
干预措施: Treatment Algorithm (Procedure)
No treatment algorithm
Mitral valve will be repaired or replaced at surgeon's discretion.
干预措施: No Treatment Algorithm (Procedure)
结局指标
主要结局
Left ventricle end-systolic volume indexed to body surface area
时间窗: 12 months after surgery
Comparison of changes in the indexed volume of the left ventricle.
次要结局
- Change in right ventricle systolic pressure(Up to 12 months after surgery)
- Major adverse events(Up to 12 months after surgery)
- Change in indexed left atrial volume(Up to 12 months after surgery)
