跳至主要内容
临床试验/NCT04014140
NCT04014140招募中不适用

Long-term Graft Patency Outcomes of LIMA-LAD Post-CABG Surgery Based on iFR Measurements.

Prakash Punjabi1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年4月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Graft patency

研究概览

简要总结

The expected outcome of better and improved patency of bypass grafts and its direct relation to pre-operative iFR measurements of stenosis as compared to direct visual physiology of stenosis in the coronary angiogram.

To establish the correlation between the use of intracoronary physiology and improved graft patency at 12 months for patients undergoing CABG surgery.

It is a minimum of 28 and a maximum of 100 patients single-centre proof or concept/ observational study/ pilot study.

详细描述

Patients suffering from coronary artery disease undergo coronary artery bypass grafting surgery (CABG) as the standard of care. The selection of which vessels to bypass is usually at the discretion of the surgeon forming an opinion based on the pre-operative angiographic imaging. Intra-coronary physiology (iFR measurements) is more accurate to determine the level of damage to the coronary arteries; however, currently it is not used for CABG pre-assessment, but only for percutaneous intervention also known as stenting as it has been shown to improve outcomes. Although, the use of intracoronary physiology has not been extensively studied or validated in patients undergoing CABG.

Patients with multi-vessel coronary artery disease (CAD) who are planned for surgical revascularization with coronary artery bypass grafting (CABG), will have iFR measurement taken during invasive coronary angiography as part of standard care, they will undergo CABG and will have echocardiography at 3 months and computed tomography coronary angiography (CTCA) at 12 months.

Early graft failure will be assessed by the presentation of any clinical symptoms, major adverse cardiovascular and cerebrovascular events (MACCE) and echocardiography at 3 months. The endpoint will be graft patency as assessed by CT coronary angiography at 12 months.

Anticipated recruitment is 12-24 months. Follow-up with echocardiography at 3 months and a CTCA at 12 months. Quality of Life questionnaire will be completed by the patient at 3 and 12 months during the follow-up appointment.

Patients will continue on optimal medical therapy. Clinic visit and quality of life scale questionnaires will be recorded at 3 and 12 months and echocardiography will be assessed at 3 months. Graft patency at 12 months will be assessed with a CT coronary angiography.

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
25 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Graft patency

时间窗: 12 months

The primary endpoint will be graft patency as assessed by CT coronary angiography at 12 months.

次要结局

  • Incident of Death (cardiovascular)(12 months)
  • Composite of MACE (MI, Death, stroke, repeat revascularisation)(12 months)
  • Incidence of Myocardial infarction(12 months)
  • Incidence of Stroke(12 months)
  • Left ventricular function at 3 months with an echocardiography(3 months)
  • Quality of Life Questionnaire(3 and 12 months)
  • Any episode of reintervention(12 months)
  • Incidence of Death (all-cause)(12 months)

研究者

发起方
Prakash Punjabi
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Prakash Punjabi

Consultant Cardiothoracic Surgeon

Imperial College Healthcare NHS Trust

研究点 (1)

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