CORAL: Economics and QOL Core Laboratory

CORAL：经济与生活质量核心实验室

• 批准号: 7045960
• 负责人: David J Cohen
• 金额: $ 26.5万
• 依托单位: BETH ISRAEL DEACONESS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-04-01 至 2006-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7045960
• 关键词: artery stenosis; atherosclerosis; cardiovascular disorder therapy; cardiovascular function; clinical research; clinical trials; combination therapy; congestive heart failure; cooperative study; cost effectiveness; creatinine; health care policy; hospital utilization; human subject; human therapy evaluation; intraluminal angioplasty; kidney function; longitudinal human study; myocardial infarction; patient oriented research; quality of life; questionnaires; renal artery obstruction; renal hypertension; stroke

DESCRIPTION (provided by applicant): Health-relatedness and Long-term Objectives: Atherosclerotic renal artery stenosis is a common problem for which there is no clear consensus on diagnosis or therapy. There likely exists a progression wherein renal ischemia leads to neuroendocdne activation, hypertension, and renal insufficiency potentially resulting in acceleration of therosclerosis, further renal dysfunction, myocardial infarction, stroke and death. The current proposal tests whether revascularization of a stenotic renal artery plus optimum medical therapy is associated with improved clinical outcomes when compared with optimum medical therapy alone. Specific Aims, Design and Methods: Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL) is a randomized clinical trial that will contrast the effect of optimum medical therapy alone to stenting with optimum medical therapy, on a composite cardiovascular and renal endpoint: cardiovascular or renal death, myocardial infarction, hospitalization for congestive heart failure, stroke, doubling of serum creatinine level, and need for renal replacement therapy. This endpoint will be adjudicated by a clinical events committee masked to treatment assignment. The secondary endpoints 1) evaluate the mechanisms linked to clinical events; 2) describe differential effectiveness in critical end-organs; 3) determine the value of stenting from the patient and the health policy perspectives, measured as quality of life and cost effectiveness; and 4) evaluate for clinically relevant differences in treatment effectiveness within the primary endpoint. The primary entry criteria are an atherosclerotic renal stenosis >=60% with a 20 mmHg systolic pressure gradient and systolic hypertension >155 mmHg on 2 or more anti-hypertensive medications. A slight predominance of women is expected, and high priority will be placed on minority recruitment. Approximately 2200 patients will undergo a baseline evaluation with randomization occurring in 1080. The study has 90% power to detect a 28% reduction in primary endpoint hazard rate. This R01, from the economics and quality of life core laboratory, describes the additional data collection and analyses that are proposed to determine the benefits of renal artery stenting on health-related quality of life and the cost-effectiveness of renal artery stenting in terms of a standard metric-cost per quality-adjusted year of life gained.

描述（由申请人提供）：