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临床试验/NCT03292497
NCT03292497进行中(未招募)不适用

Prospective Treatment Algorithm Guiding Repair of Severe Ischemic Mitral Regurgitation: Canadian Mitral Research Alliance (CAMRA) 2 Trial

Ottawa Heart Institute Research Corporation2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2018年1月16日最近更新:
适应症
干预措施

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

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

Experimental

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

Active Comparator

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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