ISCHEMIA-CKD SDCC

缺血性CKD SDCC

基本信息

批准号：
8480722
负责人：
Sean M O'Brien
金额：
$ 35.1万
依托单位：
DUKE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-09-20 至 2019-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8480722
关键词：
Acute Acute Renal Failure with Renal Papillary Necrosis Acute myocardial infarction Address Ancillary Study Angiography Angioplasty Bypass Cardiac Cardiac Catheterization Procedures Cardiovascular system Caring Catheterization Cessation of life Chronic Kidney Failure Clinical Clinical Data Clinical Trials Data Monitoring Committees Clinical Trials Design Companions Comparative Study Coronary Arteriosclerosis Coronary artery Data Data Collection Data Coordinating Center Diabetes Mellitus Dialysis procedure Disease Drug Evaluation EFRAC Economics Effectiveness End stage renal failure Enrollment Equipoise Event Failure Frequencies Fright Funding Glomerular Filtration Rate Goals Health Health Resources Healthy People 2020 Heart Arrest Heart failure Hospitalization Image Incidence Information Systems Institute of Medicine (U.S.)Intention International Investigation Ischemia Leadership Life Life Style Living Costs Malignant Neoplasms Medical Myocardial Infarction Myocardial Ischemia National Heart, Lung, and Blood Institute Obesity Observational Study Operative Surgical Procedures Outcome Participant Patient-Focused Outcomes Patients Pharmaceutical Preparations Phase Policies Population Preparation Prevalence Process Publications Qualifying Quality of life Questionnaires Randomized Randomized Controlled Trials Refractory Reporting Research Design Risk Stents Stress Stress Tests Stroke Summary Reports Symptoms System Testing Time Unstable angina Visit acute coronary syndrome aging population clinical practice cohort comparative effectiveness cost cost effectiveness data integrity data management data sharing disorder risk effectiveness research electronic data follow-up health economics high risk improved international center mortality outcome forecast prevent prospective protocol development public health relevance screening surveillance data tool treatment strategy trial comparing

项目摘要

DESCRIPTION (provided by applicant): PROJECT SUMMARY/ABSTRACT The objective of the proposed trial, International Study of Comparative Health Effectiveness with Medical and Invasive Approaches-Chronic Kidney Disease (ISCHEMIA-CKD) Ancillary Study, is to determine the best management strategy for stable ischemic heart disease (SIHD) patients with advanced chronic kidney disease (CKD) [defined as estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2) or on dialysis] and moderate-severe ischemia. ISCHEMIA-CKD will be a prospective, multicenter, international, randomized, controlled trial, conducted as a trial within the main ISCHEMIA trial that will enroll 1,000 SIHD patients with advanced CKD with moderate-severe ischemia by stress imaging and ejection fraction e35%. The trial hypothesis is that for patients with moderate-severe ischemia on stress imaging, a routine invasive strategy (INV) with cardiac catheterization (cath) followed by revascularization plus optimal medical therapy (OMT) is superior to a conservative strategy (CON) of OMT, with cath and revascularization reserved for patients who fail OMT. The primary endpoint will be time to death from any cause or myocardial infarction (MI). Quality of life and cost-effectiveness will also be compared between the two strategies. Patients with CKD are more likely to die than reach end stage renal disease (ESRD) and are therefore considered coronary artery disease (CAD) risk equivalents. The prognosis of patients with advanced CKD is poor with a mortality rate as high as 50-70% at 4-years and is worse than that for patients who have cancers, heart failure, stroke or acute MI. Despite this high risk of death, ~80% of recent CAD trials exclude CKD subjects and most of the treatments aimed at reducing their events are therefore extrapolated from cohorts without CKD. Advanced CKD subjects are underrepresented in contemporary trials comparing revascularization with medical therapy in SIHD patients such as the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial, or the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial, making any assessment about the utility of revascularization plus medical therapy vs. initial medical therapy alone in ths cohort problematic. Limited observational studies have suggested a possible survival benefit of revascularization but yet it is rarely (10-45%) performed for fear of acute complications including contrast induced acute kidney injury, indicating substantial equipoise in current clinical practice As we prepare for the CKD boom with an aging population and increasing prevalence of diabetes and obesity, and if one of the major goals as set by Healthy People 2020 (improving survival and quality of life for people with CKD) is to be accomplished, a treatment strategy trial such as the ISCHEMIA- CKD trial is urgently needed to target a reduction in death and cardiovascular events in this high-risk population. The importance of this question to be addressed by ISCHEMIA-CKD is the reason it was ranked by the Institute of Medicine among the top 100 US priorities for comparative effectiveness research.

描述（由申请人提供）：项目摘要/摘要拟议试验“药物和侵入性方法的比较健康有效性国际研究 - 慢性肾病 (ISCHEMIA-CKD) 辅助研究”的目的是确定稳定的最佳管理策略缺血性心脏病 (SIHD) 合并晚期慢性肾病 (CKD) 患者 [定义为估计肾小球滤过率 (eGFR) <30 mL/min/1.73m2）或透析]和中重度缺血。 ISCHEMIA-CKD 将是一项前瞻性、多中心、国际、随机、对照试验，作为主要 ISCHEMIA 试验中的一项试验进行，该试验将招募 1,000 名患有晚期 CKD 的 SIHD 患者，经应力成像和射血分数 e35% 诊断为中重度缺血。试验假设是，对于应力成像中重度缺血的患者，常规侵入性策略（INV）加心导管插入术（cath）然后血运重建加最佳药物治疗（OMT）优于保守策略（CON）OMT ，导管和血运重建保留给 OMT 失败的患者。主要终点是全因死亡或心肌梗死 (MI) 的时间。还将比较两种策略之间的生活质量和成本效益。 CKD 患者比达到终末期肾病 (ESRD) 的患者更有可能死亡，因此被视为冠状动脉疾病 (CAD) 的风险相当者。晚期CKD患者的预后较差，4年死亡率高达50-70%，比癌症、心力衰竭、中风或急性心肌梗死患者的预后更差。尽管死亡风险很高，但最近约 80% 的 CAD 试验排除了 CKD 受试者，因此大多数旨在减少其事件的治疗都是从无 CKD 的队列中推断出来的。在比较 SIHD 患者血运重建与药物治疗的当代试验中，晚期 CKD 受试者的代表性不足，例如旁路血管成形术血运重建调查 2 糖尿病 (BARI 2D) 试验或利用血运重建和积极药物评估的临床结果 (COURAGE) 试验，对以下方面进行任何评估在该队列中，血运重建加药物治疗与单独初始药物治疗的效用存在问题。有限的观察性研究表明血运重建可能带来生存获益，但由于担心出现急性并发症，很少（10-45%）进行，包括对比剂引起的急性肾损伤，表明当前临床实践中的基本平衡当我们为人口老龄化以及糖尿病和肥胖症患病率不断增加的 CKD 热潮做准备时，如果“健康人 2020”设定的主要目标之一（提高生存率和质量） CKD 患者的生活目标）是一项治疗策略试验迫切需要诸如 ISCHEMIA-CKD 试验之类的试验来减少这一高危人群的死亡和心血管事件。 ISCHEMIA-CKD 所要解决的这个问题非常重要，因此它被医学研究所列为美国比较有效性研究的 100 项优先事项之一。