Ontario Provincial Registry Project for Cardiac Viability Assessment Using FDG PET
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,000
- 试验地点
- 4
- 主要终点
- The primary outcome is 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
Positron Emission Tomography (PET) is a non-invasive, unique nuclear imaging technique that allows the evaluation of blood flow in the heart and provides information about the cell activity of specific organs such as the heart and brain. It also provides useful information for the management of patients with poor pumping function of the heart, heart failure, and coronary artery disease. A cardiac viability imaging looks at how the heart uses glucose (sugar) The imaging process determines areas of the heart that are alive (viable - using sugar) versus areas of the heart that are scar tissue (non-viable). F-18 fluorodeoxyglucose (FDG) is the radioactive substance used to determine myocardial viability. This nuclear imaging technique has been shown to be useful in directing management for patient care.
The Ministry of Health recognizes the clinical utility of FDG PET imaging for myocardial viability assessment and other cancer indications. Optimizing the potential advantages of FDG PET in Ontario, will require characterization of the patient population, referral patterns, upstream and downstream resource utilization and patient outcomes. Therefore, registry studies are being undertaken to provide specific information about the utility of PET in these clinical situations in Ontario. The proposed registry will facilitate monitoring of the implementation of this limited technology and allow continued evaluation of practice patterns and outcomes. The University of Ottawa Heart Institute is the coordinating centre for this project with PET centres in London, Hamilton and Toronto also participating.
The purpose of this study is to evaluate the utility of FDG PET viability imaging in the decision making process for patients with poor left ventricular function who may be candidates for revascularization and to study the downstream effect of the clinical management decisions. Patients meeting specific inclusion criteria will be eligible for this study.
详细描述
Heart failure from reduced left ventricular function is associated with significant morbidity and mortality and although there have been multiple trials involving medical and devices therapies that have shown improved survival, the overall mortality remains high. Therapeutic intervention studies involving transplantation and revascularization concluded that patients with viable myocardium can be revascularized but this approach is often not adopted because of high peri-operative morbidity and mortality.
Due to these factors there is a need for a better approach to define and select patients with severe ventricular dysfunction. FDG PET studies to date have consistently shown that patients with viable myocardium on FDG PET are at high risk for other cardiac events and death if they do not undergo timely revascularization. FDG PET viability data has had an impact on decision making in patients with severe left ventricular (LV) dysfunction and the benefits of early revascularization have been seen in patients with ischemic viable myocardium.
The accuracy of FDG PET to predict regional and global LV function recovery, its utility in decision making and ability to identify high risk patients have all been demonstrated. These findings all support a clinical role for FDG PET in assessing select patients with CAD and severe LV function. The Cardiac FDG PET Registry (CADRE) will provide specific information about the utility of PET in clinical situations. To our knowledge this is the largest multi-centre FDG PET myocardial viability registry. The registry will facilitate monitoring of and evaluation of practise patterns, upstream and downstream resource utilization (diagnostic imaging and revascularization) and outcomes as they relate to the severity of the abnormalities detected. The impact of FDG PET parameters on outcome measures will be compared to other clinical parameters. These findings will optimize the implementation of this technology in clinical practise in Ontario and further identify parameters that with FDG PET predict adverse outcomes for specific patient populations. The results of this registry will impact clinical practise and health care for patients in Ontario and internationally.
- Research Plan
Objectives:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ischemic left ventricular dysfunction in the moderate to severe range (previous assessment of ventricular function with left ventricular ejection fraction (LVEF) approximately 35%
- •Patients will be possible candidates for revascularization if sufficient viable myocardium is identified or considered for heart transplantation if there is no viable myocardium
- •Patients with New York Heart Association (NYHA) or Canadian Cardiovascular Society (CCS) Class II - IV symptoms despite maximal medical therapy.
排除标准
- •Under 18 years of age
- •Pregnant or lactating females
- •Already known to be ineligible for further revascularization or cardiac transplantation
- •Unable to lie supine for imaging with PET
- •Unable to take insulin (eg. severe hypokalemia)
- •Failure to obtain informed consent
- •Claustrophobia.
结局指标
主要结局
The primary outcome is the composite clinical endpoint of cardiac death, myocardial infarction, transplantation, or re-hospitalization for unstable angina or heart failure.
时间窗: 1 year
次要结局
- Other outcomes will include death from any cause, revascularization, and downstream diagnostic utilization.(1 year)
研究者
Rob Beanlands
Robert S. Beanlands, MD, FRCPC, Chief of Cardiology
Ottawa Heart Institute Research Corporation