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

基本信息

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
项目类别：
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

项目摘要

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.

项目概要/摘要目前尚无针对慢性肾病 (CKD) 患者的心血管 (CV) 风险预测工具在今天的临床实践中。事实上，CKD 患者心血管风险分层的最佳方法尚不确定，由于公开数据的缺乏，引起了激烈的争议和困惑。此外，传统的风险预测模型对 CKD 患者心血管事件的预测准确性不佳，低估风险高达 50%。这是鉴于 CVD 是 CKD 死亡的主要原因，这是非常有问题的。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（通过原生 T1 MRI）作为风险分层工具，但是仍然存在关于它们在 CKD 中的预后效用，临床上存在相当大的平衡。此外，新出现的证据表明评估静息状态下的 CV 结构而不是确定压力下的功能锻炼可能不够敏感，无法准确反映 CKD 中心血管疾病过早死亡的风险。虽然运动已被证明是未来心血管事件最有效的预测因素之一，但很少对其进行评估慢性肾病患者。我们小组最近的工作表明，CV 功能能力的全球指数（如使用心肺运动测试 (CPET) 通过峰值运动时的摄氧量 (VO2) 进行评估可能会提供准确预测 CKD 心血管风险的潜在解决方案。如果CPET可以用来准确预测未来的心血管事件和风险分层 CKD 患者，这可能会产生改变实践的影响。潜在的应用包括识别患者是否需要进行早期或更深入的医疗或透析治疗，在术前风险评估中，及时选择肾移植患者并确定其优先顺序重大手术并帮助指导选择进行冠状动脉造影的患者。该计划的总体目标是因此，拟议的研究是为了确定 CV 风险的最佳诊断测试和 CV 功能指数辨别和预测。该提案的中心假设是 VO2Peak 的测量对于预测晚期晚期患者未来的心血管事件，CPET 进行的诊断测试将优于其他诊断测试慢性肾病。本研究是一项概念验证单中心前瞻性研究，总共招募 n=140 种族和民族多样化的晚期 CKD 5D 期（血液透析）患者。所有患者都将接受功能（身体功能测试和 CPET）和结构（心脏 CT 和 T1 MRI）评估一年后进行基线和重复功能测试。简历结果将在三年内进行前瞻性评估。 AIM 1 (A) 将确定 VO2Peak 与其他临床使用的测试（心脏 CT、 T1 MRI（身体功能测试），用于预测 3 年心血管结果； (B) 确定是否发生变化在预测 3 年心血管结局方面，VO2Peak 优于单基线 VO2Peak。 AIM 2将开发新的风险分层模型，并评估纳入功能指数是否可以与传统风险评分相比，可以更好地预测 CKD 未来心血管结局。