Arm Exercise versus Pharmacologic Stress Testing for Clinical Outcome Prediction

手臂锻炼与药物压力测试的临床结果预测

基本信息

  • 批准号:
    9546164
  • 负责人:
  • 金额:
    --
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2018
  • 资助国家:
    美国
  • 起止时间:
    2018-07-01 至 2023-06-30
  • 项目状态:
    已结题

项目摘要

Treadmill exercise capacity and other physiologic responses to leg exercise are powerful predictors of mortality and provide important clinical and diagnostic information. However, many Veterans cannot perform treadmill exercise because of lower extremity or other disabilities. For many years, pharmacologic myocardial perfusion imaging (MPI) has been the standard of care for their evaluation but fails to provide powerful prognostic and clinically relevant information of exercise testing, requires exposure to ionizing radiation, and is several times more expensive than exercise electrocardiography (ECG). With a recently completed Merit Review award, we obtained substantial retrospective observational evidence that arm exercise ECG stress testing scores are at least equivalent to pharmacologic MPI for robust prediction of mortality and other measures of clinical outcome in Veterans who cannot perform leg exercise. Major hypotheses for the current proposal are: 1) arm exercise ECG stress testing scores or best fit models without or with coronary artery calcium scoring (-/+ CACS) are non-inferior to the Duke Treadmill Score -/+ CACS, best fit model treadmill ECG and regadenoson (r) MPI stress testing, all performed in the same Veterans in randomized order, as an initial evaluation for obstructive coronary artery disease (oCAD), and 2) arm exercise ECG stress testing scores or best fit models -/+ CACS are non-inferior to the Duke Treadmill Score -/+ CACS, best fit model treadmill ECG and rMPI stress testing in the same Veterans for predicting the primary clinical endpoint (composite of cardiovascular (CV) mortality, myocardial infarction, or 90-day post- stress test coronary revascularization) and secondary clinical endpoints of all-cause mortality and CV mortality. Our specific aim for all Veterans referred to the St. Louis Veterans Administration (VA) stress testing laboratory and are without exclusions for exercise or regadenoson stress testing or cardiac computed tomographic angiography (CTA), is to perform a single site prospective clinical trial comparing arm exercise ECG stress test scores and best models -/+ CACS with the Duke Treadmill Score -/+ CACS if able to perform treadmill exercise, and best fit treadmill ECG and rMPI models, all performed in the same Veterans, for identification of the diagnostic endpoint of oCAD, defined as a severely (≥70%) occluded epicardial, graft, or ≥50% left main coronary artery lumen, determined by cardiac CTA or invasive coronary arteriography, and prediction of the primary and secondary clinical endpoints described above. The arm exercise scoring system to be evaluated incorporates the variables arm exercise capacity in resting metabolic equivalents, 1-minute heart rate recovery and arm exercise-induced ST depression ≥1 mm. Regadenoson MPI variables to be evaluated include an abnormal MPI study and best fit models of summed stress and difference scores, transient ischemic dilatation, gated left ventricular ejection fraction, and the heart rate response. We plan to enroll 75 Veterans per year for 4 years and follow the entire cohort for an additional year. Statistical analyses will be performed with SAS using univariate and multivariate logistic and Cox regression models. We will evaluate non-inferiority of arm exercise scores -/+ CACS for their association with oCAD and prediction of clinical endpoints with a non-inferiority margin of 0.05. A long term goal is to develop a multi-site prospective randomized VA Cooperative Study to assess generalizability of arm exercise ECG stress testing -/+ CACS for diagnostic and prognostic evaluation in the VA and United States healthcare systems.
跑步机运动能力和对腿运动的其他生理反应是强大的 预测死亡率并提供重要的临床和诊断信息。但是,很多 由于下肢或其他疾病,退伍军人无法进行跑步机运动。为了 多年来,药理学心肌灌注成像(MPI)一直是护理标准 进行评估,但无法提供强大的预后和临床相关信息 运动测试,需要暴露于电离辐射,并且昂贵几倍 比运动心电图(ECG)。有了最近完成的功绩审查奖,我们 获得了大量的回顾性观察证据,表明手臂锻炼ECG压力测试 评分至少等同于药物MPI,以稳健地预测死亡率和其他 无法进行腿部运动的退伍军人中的临床结果度量。主要假设 对于当前的建议是:1)手臂运动ECG应力测试分数或最佳拟合模型 没有冠状动脉钙评分( - /+ CAC)不在杜克 跑步机评分 - /+ CAC,最佳拟合模型跑步机ECG和Regadenoson(R)MPI应力测试, 所有这些都按随机顺序在同一退伍军人中进行,作为阻塞性的初步评估 冠状动脉疾病(OCAD)和2)手臂运动ECG应力测试分数或最佳拟合 型号 - /+ CAC不属于杜克跑步机得分 - /+ CAC,最佳拟合模型 跑步机ECG和RMPI应力测试在同一退伍军人中预测主要临床 端点(心血管(CV)死亡率,心肌梗塞或90天后的复合物 压力测试冠状动脉血运重建)和全因死亡率的次要临床终点 和简历死亡率。我们对所有参考圣路易斯退伍军人的退伍军人的具体目标 管理(VA)应力测试实验室,没有锻炼或 Regadenoson应力测试或心脏计算机层析造影术(CTA)是要执行 比较手臂运动的单一站点前瞻性临床试验,ECG压力测试评分和最佳 型号 - /+ CAC,带有杜克跑步机得分 - /+ CAC,如果能够执行跑步机运动, 以及最适合的跑步机ECG和RMPI型号,均以同一退伍军人的形式执行 OCAD的诊断终点的识别,被定义为严重(≥70%)的闭塞 心外膜,移植物或≥50%的左主冠状动脉腔,由心脏CTA或 侵入性冠状动脉造影,以及原发性和次要临床终点的预测 上面描述。要评估的手臂运动评分系统包括变量 静止代谢当量,1分钟的心率恢复和手臂的手臂运动能力 运动引起的ST抑郁≥1mm。要评估的Regadenoson MPI变量包括 MPI的异常研究和夏季应力和差异评分的最佳拟合模型,瞬态 缺血性扩张,门控左心室射血分数和心率反应。我们计划 每年招募75名退伍军人4年,并遵循整个队列的额外一年。 统计分析将使用单变量和多元物流和 Cox回归模型。我们将评估ARM运动得分的不效率 - /+ CACS 他们与OCAD的关联以及对临床终点的预测 0.05。一个长期目标是开发多站点的前瞻性随机VA合作研究 评估手臂锻炼的概括性ECG应力测试 - /+ CAC进行诊断和 VA和美国医疗保健系统中的预后评估。

项目成果

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Wade Hampton Martin其他文献

Wade Hampton Martin的其他文献

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{{ truncateString('Wade Hampton Martin', 18)}}的其他基金

Arm Exercise versus Pharmacologic Stress Testing for Clinical Outcome Prediction
手臂锻炼与药物压力测试的临床结果预测
  • 批准号:
    9932925
  • 财政年份:
    2018
  • 资助金额:
    --
  • 项目类别:
Arm Exercise versus Other Stress Test Modalities for Clinical Outcome Prediction
手臂锻炼与其他压力测试方式的临床结果预测
  • 批准号:
    8245562
  • 财政年份:
    2010
  • 资助金额:
    --
  • 项目类别:
Arm Exercise versus Other Stress Test Modalities for Clinical Outcome Prediction
手臂锻炼与其他压力测试方式的临床结果预测
  • 批准号:
    8040623
  • 财政年份:
    2010
  • 资助金额:
    --
  • 项目类别:
Arm Exercise versus Other Stress Test Modalities for Clinical Outcome Prediction
手臂锻炼与其他压力测试方式的临床结果预测
  • 批准号:
    8391097
  • 财政年份:
    2010
  • 资助金额:
    --
  • 项目类别:
Arm Exercise versus Other Stress Test Modalities for Clinical Outcome Prediction
手臂锻炼与其他压力测试方式的临床结果预测
  • 批准号:
    8586876
  • 财政年份:
    2010
  • 资助金额:
    --
  • 项目类别:

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