跳至主要内容
临床试验/NCT03657199
NCT03657199已完成不适用

Early Silent Graft Failure in Off-pump Coronary Artery Bypass Grafting: A Computed Tomography Analysis

Triemli Hospital0 个研究点目标入组 192 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
192
主要终点
Early postoperative graft failure

研究概览

简要总结

Aortocoronary bypass surgery is one of the most common operations in the western world. The goal of the surgeon is to perform a complete revascularization of the coronary arteries with the best, available bypass material.

Aortocoronary bypass surgery can be performed with (on-pump) or without (off-pump) the heart lung machine. If the operation is performed without the heart lung machine, the heart is continuously beating while the surgeon sews the bypass to the diseased coronary artery. In randomized trials, the benefits of the off-pump technique in the hands of experienced surgeons in terms of shorter operating times, less transfusions and less pulmonary and renal complications were proven. A criticism of the off-pump technique is the reduced number of distal anastomoses, which means that fewer coronary arteries may be connected with bypass grafts because of the technically sophisticated situation. A worse quality of the connection (anastomosis) between coronary artery and bypass is often discussed, leading to a bypass occlusion already in the early stage after surgery resulting in more re-interventions on the coronary vessels. So-called silent bypass failure without clinical correlation has been examined in three relevant studies including both, the on- and the off-pump technique, with inhomogenous results. In addition to the technique, other parameters such as the degree of narrowing (stenosis) of the diseased coronary artery and collateralization of a closed coronary artery may play a role in early occlusion.

All bypass patients after off-pump surgery receive routinely a computed tomographic examination of the heart. With this method, silent bypass occlusions without clinical correlation, i.e. cardiac infarction, elevated cardiac laboratory parameters or ECG changes, can be detected easily. In case of an occlusion of a relevant bypass, an intervention before discharge can be planned and performed.

We would like to investigate the occlusion rate of this retrospective patient cohort after off-pump surgery and the potential risk factors, that may influence on early graft failure. We hypothesize, that early graft failure depends not only on the choice of the graft material, but also on the local grade of coronary stenosis, the collateralisation of occluded coronary vessels and the intraoperative flow results, as well as on the region of the target vessel.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • patients after off-pump coronary artery bypass grafting
  • postoperative computed tomography for the evaluation of the bypass patency before discharge

排除标准

  • Operation with a heart-lung machine
  • Combined interventions
  • Postoperative emergency coronary angiography
  • There is a documented rejection

结局指标

主要结局

Early postoperative graft failure

时间窗: first week after aortocoronary bypass grafting

Assessment of graft failure by computed tomography in all patients after isolated off-pump surgery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alicja Zientara

resident for cardiac surgery

Triemli Hospital

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