CORAL: Data Coordinating Center

CORAL：数据协调中心

• 批准号: 7062435
• 负责人: Donald Cutlip
• 金额: $ 94万
• 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: 2004-04-15 至 2010-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7062435
• 关键词: blood vessel prosthesis; cardiovascular disorder; clinical research; clinical trials; cooperative study; data collection methodology /evaluation; data quality /integrity; human therapy evaluation; kidney surgery; renal artery; statistics /biometry

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）： 与健康相关性和长期目标：动脉粥样硬化肾动脉狭窄是一个常见的问题，在诊断或治疗上没有明确的共识。可能存在一种进展，其中肾脏缺血导致神经内聚类，高血压和肾功能不全可能导致治疗加速，进一步的肾功能障碍，心肌梗塞，中风和死亡。当前的建议测试狭窄肾动脉的血运重建以及与仅最佳药物治疗相比，临床结局的改善是否与改善的临床治疗有关。 具体目的，设计和方法：肾动脉粥样硬化病变（珊瑚）的心血管结局是一项随机临床试验，它将形成对比最佳药物治疗与最佳药物治疗，对心血管造成的综合终点和肾脏终点的构成的影响：心血管或肾脏死亡，心脏疾病，心脏病，病因，构造，构造，促进，构造，构造，构造，构成，构成，构成，构成，构成，构成成群的成群，累积的成群成标，累积的成群，累积的成群，累积的成群，累积的成群，累积的促进性。水平和肾脏替代疗法的需求。临床事件委员会将裁定该终点以掩盖治疗作业。次要终点1）评估与临床事件相关的机制； 2）描述关键端孔中的差异效果； 3）从患者和健康政策的角度确定支架的价值，以生活质量和成本效益衡量； 4）评估主要终点内治疗有效性的临床相关差异。主要进入标准是动脉粥样硬化的肾脏狭窄> 60％，具有20 mmHg收缩压梯度，而收缩压高血压> 155 mmHg> 155 mmHg，可在2个或更多的抗高血压药物上进行。预计妇女会有少量的优势，并且将在少数族裔招募方面被放在很高的优先级。大约2200名患者将接受基线评估，随机分组在1080年。该研究具有90％的功率，可检测一级终点危险率降低28％。临床协调中心的R01描述了主要的研究假设和整体试验行为。