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临床试验/NCT00385242
NCT00385242已完成3 期

PET and Recovery Following Revascularization: Outcome and Cost-effectiveness of FDG PET in Left Ventricular Dysfunction (PARR 2)

Ottawa Heart Institute Research Corporation2 个研究点 分布在 1 个国家目标入组 430 人开始时间: 2000年6月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
430
试验地点
2
主要终点
time to occurence of the composite clinical endpoint of cardiac death,myocardial infarction, transplantation, or re-hospitalization for unstable angina or heart failure.

研究概览

简要总结

Rationale: Patients with severe ventricular dysfunction and coronary disease have high morbidity and mortality. They may benefit from revascularization, but have significant peri-operative morbidity and mortality. Positron emission tomography (PET) imaging with F-18-fluorodeoxyglucose (FDG) can detect viable myocardium that may recover from revascularization in such patients. It is unclear whether use of FDG PET in this population is improves outcome or is cost-effective.

Objectives: The principal aim is to determine whether FDG PET-guided therapy is effective versus standard care. Secondary objectives are to determine whether FDG PET-guided therapy improves LV function, quality of life and is good value for money versus standard care.

详细描述

Patients with severe ventricular dysfunction and coronary artery disease have high morbidity and mortality but may benefit from revascularization. However, there is also significant peri-operative morbidity and mortality among these patients. This accounts for the variable approach to these patients in different cardiac centres. Clearly this patient group has the most to gain when coronary revascularization is beneficial, but also the most to lose when it is not helpful. There is a need for an approach that can better define patients with severe ventricular dysfunction due to ischemia, who will be more likely to benefit from revascularization. Positron emission tomography (PET) imaging with F-18-Fluorodeoxyglucose (FDG) has been used to evaluate patients with ventricular dysfunction, to detect ischemic but viable myocardium more likely to recover from revascularization. Recently retrospective studies have shown that FDG PET can identify patients at high risk for cardiac events if they do not undergo revascularization. However, these studies did not evaluate whether FDG PET actually directed therapy decisions and because of their study design, could not determine whether FDG PET altered patient outcome. Our recent studies have shown that FDG PET can have important impact on therapy decisions and that patients with ischemic but viable myocardium are at increased risk. However it remains unclear whether an approach which utilizes FDG PET to define ischemic but viable myocardium can have a beneficial effect on patient outcome. It is also important to consider the potential clinical impact of FDG PET balanced against its limited availability. In addition, despite the cost of the technology, preliminary data from our group and others suggest a potential cost savings. Accordingly, a prospective randomized study is needed to evaluate whether FDG PET directed therapy has a beneficial effect on patient outcome and is cost-effective.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
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

入选标准

  • Patient is > 18 years of age.
  • Documented ejection fraction of <35% attributable to CAD.
  • Documented CAD
  • Any patient being considered for revascularization, transplant/heart failure work up or where, in the opinion of the attending physician or surgeon, viability imaging would be considered useful in ongoing clinical management decisions.

排除标准

  • Other co-morbid conditions making survival unlikely
  • < 6 weeks post myocardial infarction
  • CAD unsuitable for revascularization
  • emergency revascularization is required.
  • severe valvular disease that requires surgery.
  • Geographically inaccessible
  • Lack of informed consent.

结局指标

主要结局

time to occurence of the composite clinical endpoint of cardiac death,myocardial infarction, transplantation, or re-hospitalization for unstable angina or heart failure.

时间窗: 5 years

次要结局

  • occurrence of the composite endpoint; individual components of the composite endpoint; quality of life, costs, and cost-effectiveness of PET-guided therapy versus control.(5 years)

研究者

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

Rob Beanlands

Rob S. Beanlands, MD, FRCPC, Chief of Cardiology

Ottawa Heart Institute Research Corporation

研究点 (2)

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