ISCHEMIA-CKD SDCC

缺血性CKD SDCC

• 批准号: 8738708
• 负责人: Sean M O'Brien
• 金额: $ 18.81万
• 依托单位: DUKE UNIVERSITY
• 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 2019-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8738708
• 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

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：拟议试验的目的是医学和侵入性方法比较健康有效性的国际研究-慢性肾脏疾病（ischemia -CKD）辅助研究，旨在确定稳定性缺血性心脏病（SIHD）合并晚期慢性肾脏疾病（CKD）（定义为估计肾小球滤过率(eGFR) <30 mL/min/1.73m2）或透析的患者和中重度缺血的最佳管理策略。缺血-CKD将是一项前瞻性、多中心、国际、随机、对照试验，作为主要缺血试验的一项试验，通过应激成像和射血分数为35%，招募1000名SIHD合并中重度缺血的晚期CKD患者。本试验假设，对于应激成像显示的中重度缺血患者，常规有创策略（INV）心导管置入术(cath) +血运重建术+最佳药物治疗（OMT）优于保守策略（CON） OMT，对于OMT失败的患者保留导管和血运重建术。主要终点是任何原因导致的死亡时间或心肌梗死（MI）。还将比较两种战略之间的生活质量和成本效益。CKD患者比终末期肾病（ESRD）更容易死亡，因此被认为是冠状动脉疾病（CAD）的同等风险。晚期CKD患者的预后很差，4年死亡率高达50-70%，比患有癌症、心力衰竭、中风或急性心肌梗死的患者更糟。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CKD事件的治疗都是从无CKD的队列中推断出来的。晚期CKD患者在比较SIHD患者血运重建术与药物治疗的当代试验中代表性不足，如旁路血管成形术血运重建术调查2糖尿病（BARI 2D）试验，或利用血运重建术和积极药物评估（COURAGE）试验，这使得在该队列中对血运重建术加药物治疗与初始药物治疗的有效性的任何评估都存在问题。有限的观察性研究表明，血运重建术可能对生存有好处，但由于担心急性并发症，很少（10-45%）进行