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Long Term Follow-up of Robotic Assisted Surgical Revascularization (ZEUSFUPCTA)

2018年11月2日 更新者:Lawson Health Research Institute

Long Term Follow-up of Robotic Assisted Surgical Revascularization With CT Angiography

The objectives of the 2-year study are two-fold:

  1. To determine the 5-7 year patency rate (rate of open bypass grafts) of the LITA graft of patients who have already had robotically-assisted CABG surgery using CTA and MPS-MIBI
  2. To determine patient quality of life at 5-7 years after robotically-assisted CABG surgery

研究概览

地位

完全的

详细说明

New techniques such as robotically-assisted CABG surgery need proper evaluation to ensure potential benefits gained are not harmful to that which we know to be of significant benefit to the patients, that being the left internal thoracic artery (LITA) graft (one of the main coronary arteries supplying your heart with blood). We are therefore proposing a 5-7 year CT-Angiography (CTA) and Myocardial Perfusion Scintigraphy (MPS-MIBI) to assess the patency rate of the LITA graft in patients that have already undergone robotically assisted CABG.

Between September 1999 and December 2001, a single surgeon performed robotically-assisted CABG surgery with LITA-to-LAD anastomosis on 151 patients with single vessel coronary artery disease at the London Health Sciences Centre, University Hospital. Patient consent and Research Ethics approval from The University of Western Ontario was acquired prior to each procedure. Sixty-one patients had robotically-assisted CABG surgery using the Automated Endoscopic Stabilizer for Optimal Positioning (AESOP) 3000 (Computer Motion, Goleta, CA), while 90 patients had robotically-assisted CABG surgery using the Zeus telemanipulation surgical system (Computer Motion, Goleta, CA). The AESOP 3000 is a single-arm robot that facilitates video thoracoscopic LITA dissection by providing steady images and voice-activated camera control. The Zeus telemanipulation surgical system is a multi-arm robotic telemanipulator that incorporates AESOP and allows control of surgical instruments within the thorax from a distant console.

Postoperative angiography was completed prior to discharge whenever possible. Patients continue to be followed on an annual basis. Our intent to perform follow-up angiography and MPS-MIBI at 5 and 10 years duration to assess LITA graft performance was discussed with each patient at the time of the original surgery. Two late deaths unrelated to surgery have been recorded in this cohort.

The 2-year study will be divided into three phases: Phase I - Patient Recruitment (4 months), Phase II - Patient Assessment with CTA, MPS-MIBI and Questionnaires (16 months) and Phase III - Data Analysis and Conclusions (4 months).

Phase I - Chart Review and Patient Recruitment (4 Months) Upon receiving approval from the Research Ethics Board at The University of Western Ontario, charts will be reviewed on all 151 robotically-assisted CABG surgery patients. Data on these patients is currently stored in a regularly updated database at our institution; however, a thorough review of all charts will be performed. Patient demographics and operative notes, as well as perioperative and postoperative complications will be reviewed. Hospital admissions, documented cardiac events and any subsequent deaths not previously documented will be recorded. Any additional pertinent data from the chart review will be entered into a study specific Microsoft Excel file maintained by a single qualified research assistant.

All 149 living robotically-assisted CABG surgery patients will be contacted and their participation in the study requested. Patients will receive an initial request by mail, with an informative letter signed by the principal investigator outlining the purpose of the study, what participation in the study involves, and the specific aims of the cardiac team at the conclusion of the study. A follow-up phone call will be done within 3-weeks of mailing the letter to go over the content and answer any questions that patients may have.

Phase II - Patient Assessment via CTA, MPS-MIBI and Questionnaires (16 Months)

Robotically-assisted CABG surgery patients that agree to be a part of the study will have arrangements made for them to travel to LHSC. Patients will undergo a structured half-day (approximately 4-6 hours) at the hospital consisting of the following:

  1. Selective coronary artery and LITA graft check via CTA with a 64 slice CT scanner + Rest MPS-MIBI then Stress MPS-MIBI (4-6hrs)
  2. Completion of two validated health related quality of life questionnaires

    1. Seattle Angina Questionnaire
    2. 36-Item Short Form Health Survey

研究类型

观察性的

注册 (实际的)

150

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Ontario
      • London、Ontario、加拿大、N6A 5A5
        • London Health Sciences Centre

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

30年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

All 150 living robotically-assisted CABG surgery patients will be contacted and their participation in the study requested. Patients will receive an initial request by mail, with an informative letter signed by the principal investigator outlining the purpose of the study, what participation in the study involves, and the specific aims of the cardiac team at the conclusion of the study. A follow-up phone call will be done within 3-weeks of mailing the letter to go over the content and answer any questions that patients may have.

描述

Inclusion Criteria:

  1. Have had previous robotically-assisted CABG surgery with a LITA to LAD anastomosis with either AESOP or Zeus performed between September 1999 and December 2001 at the London Health Sciences Centre
  2. Willing to give informed consent to participate in the study

Exclusion Criteria:

  1. Expired
  2. Unable or unwilling to give informed consent
  3. History of allergic reaction to contrast material used in CTA or severe adverse reactions to medications used in MPS-MIBI procedures

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Surgical
Patients who have previously undergone robotic bypass surgery
Rest and Stress MIBI and CT Angiography

研究衡量的是什么?

主要结果指标

结果测量
大体时间
To determine the 5-7 year patency rate of the LITA graft of patients who have already had robotically-assisted CABG surgery using CTA and MPS-MIBI
大体时间:5-7 years post robotic assisted CABG
5-7 years post robotic assisted CABG

次要结果测量

结果测量
大体时间
To determine patient quality of life at 5-7 years after robotically-assisted CABG surgery
大体时间:5-7 years post robotic assisted CABG
5-7 years post robotic assisted CABG

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Bob Kiaii, MD, FRCSC、London Health Sciences Centre

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2008年6月1日

初级完成 (实际的)

2012年6月1日

研究完成 (实际的)

2017年12月1日

研究注册日期

首次提交

2008年10月15日

首先提交符合 QC 标准的

2008年10月15日

首次发布 (估计)

2008年10月17日

研究记录更新

最后更新发布 (实际的)

2018年11月6日

上次提交的符合 QC 标准的更新

2018年11月2日

最后验证

2018年11月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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