The ISCHEMIA-CKD Trial-CCC-Lead Application

ISCHEMIA-CKD 试验 CCC 主导应用

• 批准号: 9397556
• 负责人: Sripal Bangalore
• 金额: $ 117.02万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-20 至 2019-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9397556
• 关键词: Acute; Acute Renal Failure with Renal Papillary Necrosis; Acute myocardial infarction; Address; Adult; Ancillary Study; Angiography; Angioplasty; Awareness; Bypass; Cardiac Catheterization Procedures; Cardiopulmonary Resuscitation; Cardiovascular Diseases; Cardiovascular system; Caring; Catheterization; Cessation of life; Chronic Kidney Failure; Clinical; Comparative Study; Coronary Arteriosclerosis; Coronary Artery Bypass; Coronary artery; Diabetes Mellitus; Dialysis procedure; Disease; Drug Evaluation; EFRAC; Effectiveness; Elderly; End stage renal failure; Enrollment; Equipoise; Event; Frequencies; Fright; General Population; Glomerular Filtration Rate; Goals; Health; Health Policy; Health Resources; Healthcare Systems; Healthy People 2020; Heart Abnormalities; Heart Arrest; Heart failure; Hospitalization; Image; Incidence; Institute of Medicine (U.S.); Intention; International; Investigation; Ischemia; Lead; Life Style; Malignant Neoplasms; Medical; Morbidity - disease rate; Myocardial Infarction; Myocardial Ischemia; Obesity; Observational Study; Operative Surgical Procedures; Outcome; Patients; Pharmaceutical Preparations; Population; Prevalence; Quality of life; Questionnaires; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Renal function; Risk; Stents; Stress; Stroke; Symptoms; Testing; Thallium Myocardial Perfusion Imaging Stress Test; Time; Treatment Failure; United States; Unstable angina; aging population; clinical practice; cohort; comparative effectiveness; cost; cost effectiveness; disorder risk; effectiveness research; high risk; high risk population; improved; improved outcome; individual patient; mortality; optimal treatments; outcome forecast; percutaneous coronary intervention; prevent; primary endpoint; prospective; public health relevance; routine care; treatment strategy; trial comparing

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.

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）或透析]和中等重度缺血。缺血CKD将是一名前瞻性，多中心，国际，随机，对照试验，在主要缺血试验中作为试验进行，该试验将通过压力成像和射血分数E35％招募1000名具有中度严重缺血的晚期CKD的SIHD患者。试验假设是，对于应激成像中中期缺血的患者，一种常规的侵入性策略（INV），具有心脏导管插入术（CATH），然后是血运重建加上最佳药物治疗（OMT），优于OMT的保守策略（CON），与OMT保留了CATH和反射性OMT的患者。主要终点将是任何原因或心肌梗塞（MI）死亡的时间。两种策略之间还将比较生活质量和成本效益。 CKD患者比到达终阶段肾脏疾病（ESRD）更可能死亡，因此被认为是冠状动脉疾病（CAD）风险等效物。晚期CKD患者的预后较差，死亡率在4年时高达50-70％，并且比患有癌症，心力衰竭，中风或急性MI的患者要差。尽管死亡风险很高，但最近约有80％的CAD试验排除了CKD受试者，因此旨在减少其事件的大多数治疗方法都从没有CKD的同队中推断出来。在当代试验中，先进的CKD受试者的人数不足，在SIHD患者中比较血运重建与药物治疗，例如旁路血管成形术的血管成形术2糖尿病（BARI 2D）试验，或使用临床结果进行临床结果，或利用了任何使用的评估疗法的临床疗法，使得对IT的IT IT IT IT IT IT IT IT ITIS IT ITIS IT ITIS IT ITIS IN队列问题。有限的观察性研究表明，血运重建的可能生存优势，但由于担心包括急性并发症（包括10-45％） 对比诱发的急性肾脏损伤，在当前的临床实践中表明，当我们为人口老龄化和糖尿病和肥胖症患病率提高的CKD繁荣时期做准备，以及健康人2020设定的主要目标之一（改善患者的生活质量和CKD的生活质量） 迫切需要进行诸如缺血性CKD试验，以针对这种高危人群的死亡和心血管事件的减少。缺血-CKD要解决的这个问题的重要性是医学研究所将其对比较有效性研究的美国100个优先事项进行排名。