ISCHEMIA-CKD SDCC

缺血性CKD SDCC

• 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
• 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

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.

简介(由申请人提供)：项目摘要/摘要拟议试验的目的是确定对患有晚期慢性肾脏疾病(CKD)的稳定型缺血性心脏病(SIHD)患者[定义为估计肾小球滤过率(EGFR)和30毫升/分钟/1.73m2)或进行透析]和中-重度缺血的最佳治疗策略。缺血-CKD将是一项前瞻性、多中心、国际化、随机对照试验，作为主要缺血试验的一项试验进行，该试验将纳入1000名患有负荷成像和射血分数为35%的中-重度缺血的晚期CKD患者。试验假设是，对于负荷显像中重度缺血的患者，常规介入策略(INV)+心导管置入(CATH)后血运重建加最佳药物治疗(OMT)优于OMT的保守策略(CON)，将CAT和血运重建保留给OMT失败的患者。主要终点将是死于任何原因或心肌梗死(MI)的时间。生活质量和成本效益也将在这两种策略之间进行比较。CKD患者死亡的可能性比达到终末期肾病(ESRD)的可能性更大，因此被认为是冠心病(CAD)的风险等价物。晚期CKD患者预后较差，4年死亡率高达50-70%，且较癌症、心力衰竭、中风或急性心肌梗死患者差。尽管死亡风险很高，但最近的CAD试验中约80%排除了CKD受试者，因此大多数旨在减少他们事件的治疗是从没有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患者的代表性不足，例如Bypass血管成形术重新血运重建调查2糖尿病(BARI 2D)试验，或在队列中对血运重建加药物治疗与单纯初始药物治疗的有效性进行任何评估的临床结果利用血管重建和侵袭性药物评估(COURAGE)试验。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，很少进行(10-45%)。 造影剂诱导的急性肾损伤，表明在当前的临床实践中，随着人口老龄化和糖尿病和肥胖症发病率的增加，我们为慢性肾脏病的繁荣做准备，如果要实现健康人2020年设定的主要目标之一(改善慢性肾脏病患者的生存和生活质量)，治疗策略试验 例如，迫切需要进行缺血性CKD试验，以减少这一高危人群的死亡率和心血管事件。这一问题将由缺血-CKD解决的重要性是它被医学研究所列为美国比较有效性研究的前100个优先事项之一的原因。