跳至主要内容
临床试验/NCT04023058
NCT04023058暂停不适用

Stress Echo for Ischemic Mitral Valve Surgery

Saint Petersburg State University, Russia1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2020年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
暂停
发起方
入组人数
400
试验地点
1
主要终点
cardiac death

研究概览

简要总结

Comparison patients with CABG alone vs. CABG+mitral surgery with non-massive ischaemic mitral regurgitation (IMR) depending on stress echo data.

详细描述

Chronic ischaemic mitral regurgitation (IMR) is a frequent complication of coronary artery disease (CAD), and is associated with a poor prognosis and outcome. The role of concomitant mitral valve surgery for IMR in patients undergoing coronary artery bypass grafting (CABG) remains controversial. After myocardial infarction IMR is associated with poor outcome and prognosis with double mortality rates, it reduces survival following surgical or percutaneous revascularization. However, there is no consensus on the cut-off value of IMR. The thresholds to define severe secondary mitral regurgitation are need to be evaluated with regards to their impact on prognosis after mitral valve intervention. The European guidelines is defined effective regurgitant orifice (ERO)-0.2 cm2 and regurgitant volume (RV)-30ml, as the threshold for severe IMR, because of severe prognosis of this group. Whereas American guidelines are defined it as ERO-0.4 cm2 and RV-60ml, as it was no evidence to impact intervention on the IMR with ERO-0.2 cm2 and RV-30ml. Partly it's explained by the dynamic nature of the secondary MR. About 30% of patients from the group with non-massive regurgitation at rest, have dramatically increasing it during exercise. However, some patient have not changes or decreasing IMR during exercise and, probably, they have not such a negative impact on the hemodynamic by IMR. The pervious comparative studies, that were the base for recommendations did not differ the patients with and without changes IMR during exercise. The current guidelines doesn't support the stress echo (SE) exams before operation for assessing necessity in mitral valve operation. It's due to lack of information that prove of influence for survival after surgery depending on IMR dynamic parameters.

IMR study hypothesis: Stress echocardiography data, including ERO, RV, pulmonary pressure (PA) pressure, beta-lines - B-lines, contractile reserve, could be indications for mitral valve intervention in patient with CAD and chronic secondary mitral regurgitation, undergoing CABG. The patients of the group with non-massive (ERO-0.2 cm2 and RV-30ml) IMR have positive effect by mitral surgery if they have increasing IMR during exercise test. The group with massive IMR (ERO≥0.4 cm2 and RV≥60 ml) will be better according clinic, echo, stress echo results in comparison with non-massive non-operated subgroup.

Aim: To assess the value of stress echo testing for ischemic mitral surgery indication in patients undergoing CABG.

Inclusion criteria for all projects are:

  1. Age > 18 years
  2. IMR, ERO≥0.2 cm2 and RV≥30 ml.
  3. Indication for CABG

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
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

  • •Ischemic MR, ERO≥0.2 cm2 and RV≥30 ml.
  • •Indication for CABG

排除标准

  • •Unwillingness to give informed consent and to enter a regular follow-up program.
  • •Contraindications for SE.

研究组 & 干预措施

CABG/increasing MR

No Intervention

non-massive IMR with increasing IMR during exercise - CABG only

CABG+mitral surgery (MS)/increasing MR

Experimental

non-massive IMR with increasing IMR during exercise - CABG+ mitral surgery

干预措施: Mitral surgery (Procedure)

CABG/non-increasing MR

No Intervention

non-massive IMR non-increasing IMR during exercise - CABG only

CABG+MS/non-increasing MR

Experimental

non-massive IMR non-increasing IMR - CABG+ mitral surgery

干预措施: Mitral surgery (Procedure)

Control 1

Other

massive IMR at rest without increasing during exercise - CABG+ mitral surgery

干预措施: Mitral surgery (Procedure)

Control 2

Other

massive IMR at rest with increasing during exercise - CABG+ mitral surgery

干预措施: Mitral surgery (Procedure)

结局指标

主要结局

cardiac death

时间窗: during 3 year

cardiac death

new hospital readmission

时间窗: during 3 year from including

new hospitalization

myocardial infarction

时间窗: during 3 year

myocardial infarction

all-cause death

时间窗: during 3 year

all-cause death

re-operation

时间窗: during 3 year

percutaneous coronary intervention, coronary bypass surgery, heart transplant

次要结局

  • B-lines(Change from Baseline at 12 months, at 3 years)
  • Contractile reserve(Change from Baseline at 12 months, at 3 years)
  • effective regurgitant orifice(Change from Baseline at 12 months, at 3 years)
  • physical capacity(Change from Baseline of physical capacity in Watts at 12 months, at 3 years)
  • left atrium volume(Change from Baseline of left atrium volume at 12 months, at 3 years)
  • end diastolic volume of left ventricle(Change from Baseline of end diastolic volume of left ventricle at 12 months, at 3 years)
  • ejection fraction at rest and during stress echo(Change from Baseline of ejection fraction at 12 months, at 3 years)
  • right ventricle size(Change from Baseline at 12 months, at 3 years)
  • pulmonary artery pressure pressure(Change from Baseline at 12 months, at 3 years)

研究者

发起方
Saint Petersburg State University, Russia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Efremov Sergey

Deputy director for science

Saint Petersburg State University, Russia

研究点 (1)

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