Alternative Imaging Modalities in Ischemic Heart Failure (AIMI-HF) Project I-A of Imaging Modalities to Assist With Guiding Therapy and the Evaluation of Patients With Heart Failure (IMAGE-HF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,390
- 试验地点
- 21
- 主要终点
- The time to event of the composite clinical endpoint.
研究概览
简要总结
Medical imaging is one of the fastest growing sectors in health care and increases in utilization underscore the need to ensure imaging technology is developed and used effectively. Evaluation of the clinical and economic impact of such imaging lags behind the technology development. Heart failure (HF) represents the final common pathway for most forms of heart disease and morbidity and mortality remain high. There is a need to identify imaging approaches that have a positive impact on therapy decisions, patient outcomes and costs. As well as standard methods to evaluate new and emerging techniques to better test their potential in a clinical management setting.
PRIMARY OBJECTIVES: to compare the effect of HF imaging strategies on the composite clinical endpoint of cardiac death, MI, resuscitated cardiac arrest and cardiac re-hospitalization (WHF, ACS, arrhythmia). Patients with an ischemic heart disease (IHD) etiology will follow HF imaging strategy algorithms according to the question(s) asked by the physicians (is there ischemia and/or viability), in agreement with their local practices for standard and alternative imaging.
SECONDARY OBJECTIVES:
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To evaluate the effect of imaging modalities within and between the imaging subgroups (advanced (CMR and PET), PET, MRI and standard (SPECT)) on the primary and secondary outcomes in patients being evaluated either for viability and/or ischemia.
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To evaluate the impact of adherence to recommendations between modalities on outcomes in patients being evaluated for either viability or ischemia.
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To compare the effect of HF imaging strategies on:
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The incidence of revascularization procedures (PCI, CABG, none) and the interaction of the imaging strategy and types of revascularization on outcomes
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LV remodeling: LV volumes, LVEF,
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HF symptoms, NYHA class
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QOL (MLHFQ, the EQ5D)
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The evolution of serum prognostic markers in HF (e.g. BNP, RDW, hs-cTnT, hs-CRP, ST2)
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Health economics: Costs estimated through regression analysis and cost effectiveness assessed through decision modeling.
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The safety of imaging tests measured by cumulative radiation, adverse reactions to imaging contrast agents and stress testing agents will also be determined.
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The evolution of renal function (eGFR) and LV remodeling-associated biomarkers (e.g. PIIINP, OPN).
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Event rates of each component of the composite endpoint as well as the combined endpoint of CV death and HF hospitalization
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All-cause mortality
详细描述
Among patients with coronary artery disease and HF, mortality rates range from 10-60% at 1 year. Many trials have demonstrated benefit of revascularization in patients with ischemic heart disease (IHD) and LV dysfunction. Some criteria, such as severe angina or left main coronary artery stenosis may indicate the need for surgical therapy for HF patients; however, a large number of patients fall into a gray zone without clear evidence for benefit from surgical intervention. The need remains for approaches that can help better define and select the HF patients most likely to benefit from revascularization; which could be either surgical or percutaneous intervention.
Increasingly over the past three decades, information describing cardiac structure, perfusion, hemodynamics, and metabolism obtained from noninvasive cardiac imaging studies has been used to guide management decisions for patients with HF.
AIMI-HF is part of a large international team grant IMAGE-HF (Imaging Modalities to Assist with Guiding therapy and the Evaluation of patients with Heart Failure) involving 3 parallel trials addressing the role of imaging in HF patients according to HF etiology.
Primary Hypothesis of AIMI-HF:
In patients with HF due to IHD with LVEF less than or equal to 45%, a management algorithm that applies alternative advanced imaging strategies (PET or CMR) achieves a better clinical outcome measured as the composite clinical endpoint (CCE) of cardiac death, MI, resuscitated cardiac arrest and cardiac re-hospitalization (WHF, ACS, arrhythmia) than an approach with "standard care".
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
The time to event of the composite clinical endpoint.
时间窗: From enrolment until date of death or up to 60 months
Primary analysis, the time-to-event of the composite clinical endpoint of cardiac death, MI, arrest and cardiac re-hospitalization (WHF, ACS, arrhythmia) will be compared between advanced (PET or CMR) vs standard care (SPECT). A competing risk analysis will be performed using non-cardiac death. Cumulative incidence function will be used in estimating the probability of the composite endpoints in each of advanced and standard groups. The sub-distribution hazard model (Fine and Gray) will be used to compare the cumulative incidence curves. The hazard ratio and associated 95 percent confidence interval will be calculated. To adjust for possible effects of confounding variables on survival between advanced and standard, the propensity scores generated on baseline patient factors (e.g. in/outpatient, NYHA class, HF, diabetes, atrial fibrillation, renal function, obesity), site factor and status of randomized versus registry will be also included in the competing risk multivariable model.
次要结局
- LVEF change over time(3, 12 and 24 months)
- The time to event of the composite clinical endpoint viability cohort.(From enrolment until date of death or up to 60 months)
- The time to event of the composite clinical endpoint ischemia cohort.(From enrolment until date of death or up to 60 months)
- Imaging modalities: Comparing PET vs SPECT modalities and for the components of the composite(From enrolment until date of death or up to 60 months)
- The time to event of the composite clinical endpoint (PET vs MRI).(From enrolment until date of death or up to 60 months)
- Imaging modalities: Comparing PET and MRI vs SPECT modalities and for the components of the composite(From enrolment until date of death or up to 60 months)
- Imaging modalities: Comparing MRI vs SPECT modalities for the components of the composite(From enrolment until date of death or up to 60 months)
- Imaging modalities: Comparing PET vs CMR for the components of the composite(From enrolment until date of death or up to 60 months)
- Cardiac biomarkers change over time(3, 12, 24 months)
- Quality of Life assessment change over time(3, 12, 24 months)
- Revascularization rates between advanced and standard modalities(3, 12 and 24 months)
- HF symptoms between advanced and standard modalities(3, 12 and 24 months)
- Event rates between advanced and standard modalities(3, 12 and 24 months)
- LV volumes change over time(3, 12, 24 months)
研究者
Rob Beanlands
Rob S. Beanlands, MD, FRCPC, Chief of Cardiology
Ottawa Heart Institute Research Corporation