Coral: Central GFR and Biochemistry Laboratory

珊瑚：中央 GFR 和生物化学实验室

• 批准号: 6772270
• 负责人: MICHAEL W. STEFFES
• 金额: $ 15.41万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-04-15 至 2010-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6772270
• 关键词: artery stenosis; atherosclerosis; biochemistry; blood pressure; blood vessel prosthesis; cardiovascular disorder therapy; clinical research; cooperative study; cost effectiveness; creatinine; hemodynamics; high performance liquid chromatography; human subject; human therapy evaluation; kidney surgery; mass spectrometry; outcomes research; patient oriented research; quality of life; renal artery; renal ischemia /hypoxia

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 Clinical Coordinating Center describes the main study hypotheses and overall trial conduct.

描述（由申请人提供）： 健康相关性和长期目标：动脉粥样硬化性肾动脉狭窄是一个常见问题，其诊断或治疗尚无明确的共识。可能存在一种进展，其中肾缺血导致神经内分泌激活、高血压和肾功能不全，可能导致动脉粥样硬化的加速、进一步的肾功能障碍、心肌梗塞、中风和死亡。目前的提案测试了与单独的最佳药物治疗相比，狭窄肾动脉血运重建加上最佳药物治疗是否与改善临床结果相关。 具体目标、设计和方法：肾动脉粥样硬化病变的心血管结局 (CORAL) 是一项随机临床试验，将对比单独最佳药物治疗与支架置入最佳药物治疗对心血管和肾脏复合终点（心血管或肾脏死亡）的影响、心肌梗塞、因充血性心力衰竭住院、中风、血清肌酐水平加倍以及需要肾脏替代治疗。该终点将由不了解治疗分配的临床事件委员会裁决。次要终点 1) 评估与临床事件相关的机制； 2) 描述关键终末器官的差异有效性； 3) 从患者和健康政策的角度确定支架置入术的价值，以生活质量和成本效益来衡量； 4) 评估主要终点内治疗效果的临床相关差异。主要入选标准是动脉粥样硬化性肾狭窄 >60%，收缩压梯度为 20 mmHg，并且使用 2 种或多种抗高血压药物时收缩压高血压 >155 mmHg。预计女性将略占多数，并且将高度优先考虑少数族裔的招聘。大约 2200 名患者将接受基线评估，并在 1080 年进行随机化。该研究有 90% 的功效检测到主要终点危险率降低了 28%。临床协调中心的 R01 描述了主要研究假设和总体试验实施情况。