PREVENTING CONTRAST-INDUCED NEPHROPATHY

预防造影剂肾病

• 批准号: 7744739
• 负责人: Ali H Hassan
• 金额: $ 15.27万
• 依托单位: CATHAROS MEDICAL SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-01 至 2010-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7744739
• 关键词: Acute Kidney Failure; Affect; Angiography; Angioplasty; Animal Testing; Animals; Applications Grants; Arteriogram; Aspirate substance; Autologous Blood Transfusion; Back; Blood; Blood Circulation; Blood Vessels; Blood specimen; Case Management; Catheterization; Catheters; Cells; Chronic Kidney Failure; Clinic; Clinical; Clinical Trials; Complication; Contrast Media; Coronary Circulation; Data; Decision Making; Detection; Devices; Diabetes Mellitus; Diagnostic; Dialysis procedure; Distal; End stage renal failure; Evaluation; Excision; Feedback; Flow-It; General Population; Government; Healthcare Systems; Heart Diseases; Heart failure; Human; Hydration status; Image; Incidence; Injection of therapeutic agent; Intensive Care; Intensive Care Units; Kidney; Kidney Diseases; Kidney Failure; Kidney Transplantation; Lead; Left; Length of Stay; Life; Light; Measures; Medical; Modeling; Monitor; National Health and Nutrition Examination Survey; Outcome; Patients; Persons; Phase; Positioning Attribute; Procedures; Process; Pump; Recovery; Relative (related person); Reporting; Risk; Risk Factors; Screening procedure; Sentinel; Sheep; Site; Small Business Innovation Research Grant; Spectrum Analysis; Stents; System; Techniques; Testing; Time; Treatment Protocols; United States; Veins; Venous; absorption; base; blood vessel visualization; cost; design; implantation; minimally invasive; novel; optical sensor; percutaneous coronary intervention; performance tests; prevent; prophylactic; prototype; public health relevance; research clinical testing; sensor; Acute Kidney Failure; Affect; Angiography; Angioplasty; Animal Testing; Animals; Applications Grants; Arteriogram; Aspirate substance; Autologous Blood Transfusion; Back; Blood; Blood Circulation; Blood Vessels; Blood specimen; Case Management; Catheterization; Catheters; Cells; Chronic Kidney Failure; Clinic; Clinical; Clinical Trials; Complication; Contrast Media; Coronary Circulation; Data; Decision Making; Detection; Devices; Diabetes Mellitus; Diagnostic; Dialysis procedure; Distal; End stage renal failure; Evaluation; Excision; Feedback; Flow-It; General Population; Government; Healthcare Systems; Heart Diseases; Heart failure; Human; Hydration status; Image; Incidence; Injection of therapeutic agent; Intensive Care; Intensive Care Units; Kidney; Kidney Diseases; Kidney Failure; Kidney Transplantation; Lead; Left; Length of Stay; Life; Light; Measures; Medical; Modeling; Monitor; National Health and Nutrition Examination Survey; Outcome; Patients; Persons; Phase; Positioning Attribute; Procedures; Process; Pump; Recovery; Relative (related person); Reporting; Risk; Risk Factors; Screening procedure; Sentinel; Sheep; Site; Small Business Innovation Research Grant; Spectrum Analysis; Stents; System; Techniques; Testing; Time; Treatment Protocols; United States; Veins; Venous; absorption; base; blood vessel visualization; cost; design; implantation; minimally invasive; novel; optical sensor; percutaneous coronary intervention; performance tests; prevent; prophylactic; prototype; public health relevance; research clinical testing; sensor

DESCRIPTION (provided by applicant): Life saving imaging-based percutaneous coronary intervention (PCI) catheterization procedures such as stent implantation, angioplasty, and diagnostic angiography require frequent and large injections of radiopaque contrast agents in order to visualize the blood vessels. These iodinated agents are toxic to the kidney, and exposure can lead to contrast induced nephropathy (CIN), a form of acute kidney failure, in patients with pre-existing renal insufficiency. There are 180,000 new cases of CIN every year in the United States that can lead to costly prolonged hospital stays and, at the extreme, end-stage kidney disease requiring permanent dialysis and kidney transplantation. Prophylactic procedures for preventing CIN are only marginally effective, and include curtailing interventional procedures that could otherwise benefit a patient. Using established screening criteria, about 100,000 heart disease patients currently are not eligible for PCI procedures due to concomitant chronic kidney disease, and this number is expected to increase due to a "ballooning" incidence of chronic kidney disease rates among the general population, with 25% of PCI candidates having chronic kidney disease. This incidence is expected to increase by 90% within a decade. Diabetes, a common risk factor to the use of contrast agents, currently affects approximately 20 million people in the United States, and the number is anticipated to increase by 75% by 2025. Catharos is preparing a novel contrast removal system, the SENTINEL System, for clinical trials in the United States. The SENTINEL System uses a venous catheter to detect and aspirate contrast-laden blood before it enters the general circulation. A commercially-available cell salvage system can be used to minimize the amount of blood lost due to the aspiration process. This SBIR project is aimed at developing a supporting subsystem, the Contrast Extraction Monitor (CEM), for the SENTINEL System that instantaneously monitors and reports the amount of contrast being removed from the patient by the SENTINEL System. The CEM is pivotal to cost-effectively testing the SENTINEL catheter system in humans, as it would provide a direct measure of efficacy that would not otherwise be available. When approved for clinical use, the CEM will provide real-time feedback to the cardiologist that can be used to: (1) confirm that the SENTINEL aspiration system is functioning, (2) contour the treatment protocol relative to the risk of CIN, and (3) provide contrast exposure data for post- procedure case management. PUBLIC HEALTH RELEVANCE: Visualization of the blood vessels for life saving minimally invasive catheterization procedures requires the use of radiopaque contrast agents that are toxic to the kidneys. The Contrast Extraction Monitor, which is the focus of this SBIR application, will support the clinical testing of a device for removing contrast-laden blood from the patient before the contrast agent can reach the kidneys. After the Contrast Extraction Monitor is approved for clinical use, it will provide essential information about the amount of contrast removed from the patient, which is pivotal to a successful outcome.

描述（由申请人提供）：基于救生的经皮冠状动脉干预（PCI）导管插入程序，例如支架植入，血管成形术和诊断血管造影，需要经常和大量注射放射性对比剂，以便可视化血管。这些碘化剂对肾脏有毒，暴露会导致对比肾病（CIN），这是一种急性肾衰竭的形式，患有肾脏不足的患者。在美国，每年有18万例CIN病例，可能导致昂贵的医院住院，并且在极端的末期肾脏疾病中，需要永久性透析和肾脏移植。预防CIN的预防程序仅略有效，包括削减可能使患者受益的介入程序。使用已建立的筛查标准，由于慢性肾脏疾病的伴随，目前约有100,000名心脏病患者不符合PCI手术的资格，并且由于普通人群中慢性肾脏疾病率的“激增”发病率，预计这一数字将增加，其中25％患有慢性肾脏疾病的PCI候选者。预计该发生率将在十年内增加90％。糖尿病是使用造影剂的常见危险因素，目前会影响美国约2000万人，预计到2025年，该数量预计将增加75％。卡特罗斯正在准备一种新型的对比度去除系统，即前哨系统，用于美国临床试验。哨兵系统使用静脉导管在进入一般循环之前检测和抽吸对比的血液。商业上可用的细胞打捞系统可用于最大程度地减少由于抽吸过程而损失的血液量。该SBIR项目旨在为前哨系统开发一个支持子系统的对比度提取监视器（CEM），该系统即时监视并报告了前哨系统从患者中删除的对比度。 CEM是对人类哨兵导管系统进行成本有效测试的关键，因为它可以直接衡量效力，否则将无法获得。当批准临床用途时，CEM将向心脏病专家提供实时反馈，该反馈可用于以下情况：（1）确认前哨抽吸系统在运行，（2）相对于CIN风险的治疗方案以及（3）为后程序案例管理提供了对比度暴露数据。公共卫生相关性：可视化血管以挽救生命的最低侵入性导管程序，需要使用对肾脏有毒的放射性对比剂。对比度提取监视器（这是本SBIR应用的重点）将支持对对比剂到达肾脏之前从患者中去除对比度的血液的临床测试。批准对比度提取监测仪供临床使用后，它将提供有关从患者中删除的对比度的基本信息，这对于成功结果至关重要。