Redefining cardiovascular risk assessment in dialysis patients (ROCK-D) study

重新定义透析患者心血管风险评估（ROCK-D）研究

• 批准号: 10564245
• 负责人: Kenneth Lim
• 金额: $ 75.94万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-04-01 至 2028-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10564245
• 关键词: Activities of Daily Living; Address; American; American Heart Association; Arteriosclerosis; Blood Vessels; Cardiac; Cardiology; Cardiopulmonary; Cardiovascular Diseases; Cardiovascular alteration; Cardiovascular system; Cause of Death; Cessation of life; Chronic Kidney Failure; Clinical; Coronary Angiography; Data; Diagnostic tests; Dialysis patients; Dialysis procedure; Discrimination; Disease Progression; Echocardiography; Equipoise; Evaluation; Event; Exercise; Exercise Test; Fibrosis; Future; Geometry; Head; Heart; Heart failure; Hemodialysis; Hypertrophy; Impairment; Kidney Diseases; Kidney Transplantation; Left; Left Ventricular Mass; Link; Magnetic Resonance Imaging; Measurement; Measures; Medical; Modeling; Molecular; Operative Surgical Procedures; Outcome; Oxygen; Patient Selection; Patients; Physical Function; Population; Predictive Value; Prospective Studies; Provider; Publishing; Recommendation; Rest; Risk; Risk Assessment; Skeletal Muscle; Stress; Structure; System; Technology; Testing; Uncertainty; Ventricular; Work; calcification; cardiovascular risk factor; clinical practice; college; coronary artery calcification; coronary fibrosis; diagnostic tool; ethnic diversity; exercise capacity; improved; indexing; novel; patient stratification; predictive modeling; predictive tools; premature; prognostic value; prognostication; prospective; pulmonary function; racial diversity; recruit; respiratory; response; risk prediction; risk prediction model; risk stratification; sarcopenia; tool; uptake

PROJECT SUMMARY/ABSTRACT There are currently no cardiovascular (CV) risk prediction tools for patients with Chronic Kidney Disease (CKD) in clinical practice today. In fact, the optimal approach to CV risk stratification in patients with CKD is uncertain, highly contested and confounded by a paucity of published data. Furthermore, traditional risk prediction models fail in their predictive accuracy for CV events in patients with CKD, underestimating risk by up to 50%. This is exceedingly problematic, given that CVD is the leading cause of death in CKD. This has forced clinicians to consider alternative approaches such as the assessment of coronary artery calcification (CAC) score (by cardiac CT) or myocardial fibrosis (by native T1 MRI) as risk stratification tools, however there remains considerable clinical equipoise regarding their prognostic utility in CKD. Moreover, emerging evidence suggests that evaluation of CV structure at rest rather than ascertainment of function under the stress of exercise, may be insufficiently sensitive to accurately reflect the risk of premature CV death in CKD. Although exercise has been shown to be among the most potent predictors of future CV evens, it is rarely assessed in patients with CKD. Recent work by our group suggests that global indices of CV functional capacity (as assessed by oxygen uptake (VO2) at peak exercise) using cardiopulmonary exercise testing (CPET) may offer a potential solution for accurately prognosticating CV risk in CKD. If CPET could be used to accurately predict future CV events and risk stratify CKD patients, this could have practice changing implications. Potential applications include the identification of patients for earlier or more intensive medical or dialytic therapies, in the selection and prioritization of patients for timely kidney transplantation, in pre-operative risk assessment for major surgery and to help guide the selection of patients for coronary angiography. The overall aim of the proposed study is therefore to define the optimal diagnostic test and CV functional index for CV risk discrimination and prognostication. The central hypothesis of this proposal is that measurement of VO2Peak by CPET will be superior to other diagnostic tests for predicting future CV events in patients with advanced CKD. The present study is a proof-of-concept single-center prospective study that will recruit a total of n=140 racially and ethnically diverse advanced CKD stage 5D (hemodialysis) patients. All patients will undergo functional (physical function testing and CPET) and structural (cardiac CT and T1 MRI) assessments at baseline and repeat functional testing at 1-year. CV outcomes will be assessed prospectively at 3-years. AIM 1 (A) will determine the predictive value of VO2Peak compared to other clinically used tests (cardiac CT, T1 MRI, physical function testing) for predicting CV outcomes at 3-years; and (B) determine if changes in VO2Peak is superior to single baseline VO2Peak for predicting cardiovascular outcomes at 3-years. AIM 2 will develop a new risk stratification model and assess whether the inclusion of functional indices can better prognosticate future cardiovascular outcomes in CKD compared to traditional risk scores.

项目摘要/摘要 目前尚无针对慢性肾脏疾病（CKD）患者的心血管（CV）风险预测工具 今天的临床实践。实际上，CKD患者的CV风险分层的最佳方法尚不确定， 由于缺乏公开的数据而引起了极大的争议和困惑。此外，传统的风险预测模型 CKD患者对CV事件的预测准确性失败，低估了多达50％的风险。这是 鉴于CVD是CKD死亡的主要原因，因此非常有问题。这迫使临床医生 考虑替代方法，例如评估冠状动脉钙化（CAC）评分（通过 心脏CT）或心肌纤维化（通过本地T1 MRI）作为风险分层工具，但是仍然存在 关于其在CKD中的预后效用，相当大的临床设备。而且，新兴的证据 表明评估在休息时的简历结构，而不是确定功能在应力下 锻炼可能不足以准确反映CKD过早CV死亡的风险。虽然 运动已被证明是未来简历Evens的最有效的预测指标之一，很少对其进行评估 CKD患者。我们小组的最新工作表明，CV功能能力的全球指数（作为 使用心肺运动测试（CPET）通过氧气吸收（VO2）评估（VO2）可能会提供 准确预测CKD中CV风险的潜在解决方案。如果可以使用CPET准确预测 未来的简历事件和风险将CKD患者分层，这可能会有改变的影响。潜在的 申请包括在早期或更强化的医学或透析疗法中鉴定患者 在术前的风险评估中，选择和优先级及时肾脏移植 大手术并帮助指导患者的冠状动脉血管造影。总体目的 因此，拟议的研究是为了定义最佳诊断测试和简历功能指数的CV风险 歧视和预后。该提议的中心假设是vo2peak的测量 通过CPET将优于其他诊断测试，用于预测晚期患者的未来简历事件 CKD。本研究是概念验证单中心的前瞻性研究，将招募n = 140 种族和种族多样的晚期CKD期5D（血液透析）患者。所有患者都会经历 功能性（身体功能测试和CPET）以及结构性（心脏CT和T1 MRI）评估 基线和重复功能测试在1年。简历结果将在3年期间前瞻性评估。 与其他临床使用的测试相比，AIM 1（a）将确定VO2PEAK的预测值（心脏CT， T1 MRI，身体功能测试），用于预测3年的CV结果； （b）确定是否发生变化 VO2PEAK优于单基线VO2PEAK，可以预测3年的心血管结局。 AIM 2将开发新的风险分层模型，并评估包含功能指数是否可以 与传统的风险评分相比，CKD的未来心血管结局更好。