High efficiency Hyper/Hypothermia

高效高/低温

• 批准号: 7537882
• 负责人: William J. Ohley
• 金额: $ 70.78万
• 依托单位: LIFE RECOVERY SYSTEM, INC.
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-02-01 至 2012-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7537882
• 关键词: Accident and Emergency department; Acute; Adult; Affect; Animal Experiments; Animals; Clinical; Clinical Trials; Condition; Coronary; Data; Devices; Drops; Generations; Heart; Hour; Human; Infarction; Injury; Institutes; Intervention; Invasive; Investigation; Label; Life; Methods; Myocardial; Myocardial Infarction; Numbers; Patients; Phase; Physiological reperfusion; Population; Preparation; Public Health; Rate; Recovery; Reperfusion Therapy; Safety; Series; Speed; System; Temperature; Therapeutic; Time; United States Food and Drug Administration; United States National Institutes of Health; interest; natural hypothermia; size; success

DESCRIPTION (provided by applicant): Myocardial infarct continues to be a major problem affecting a large number of adults. In a series of small animal experiments, it has been shown that application of hypothermia to the compromised heart is beneficial in reducing infarct size. If the heart is made hypothermic before reperfusion, hypothermia is capable of reducing infarct size by more than 50%. Unfortunately, when treatment of hypothermia was initially examined in human trials, results were not as positive. However, post-analysis of the clinical results showed that a subset of patients who were cooled prior to reperfusion demonstrated a reduction in infarct size; those cooled after reperfusion did not show such a benefit. Thus, approaches for faster, earlier cooling are of great interest in the setting of AMI treatment. During the past several years Life Recovery Systems HD, LLC, has been developing a device (the ThermoSuit. System) that can produce hypothermia much more rapidly than has been possible before with a noninvasive approach. It can potentially cool the entire body of an adult human at a rate of more than 8C0/hour. Because it is non-invasive it is also capable of being instituted rapidly in the Emergency Department, during the typical period of delay associated with preparations for PCI (Percutaneous Coronary Intervention). Furthermore it has the potential to be made into a portable system for even earlier application. In this application we propose to clinically evaluate the use of the ThermoSuit System to cool AMI patients prior to reperfusion. This 20-patient pilot clinical trial should demonstrate the speed and ease with which therapeutic hypothermia (32 to 340C) can be reached, whether this treatment delays door-to-balloon time, and how easily the target temperature is maintained after the patients are removed from the suit. The results will also enable a preliminary assessment of whether the ThermoSuit cooling treatment introduces any additional safety issues compared to historical treatment methods. This proposed study, in addition to a co-pending animal study of infarct size vs. reperfusion temperature, will support the approval of an FDA sanctioned pivotal trial in humans for the condition of myocardial infarct. PUBLIC HEALTH RELEVANCE The use of mild hypothermia to reduce the infarct size in animals subsequent to injury has been examined by a number of recent investigations. However, despite success in small animals, the clinical results have not been positive. It is hypothesized that the timing and speed with which temperature can be lowered is a key factor. The present proposal will apply a device which can drop the temperature in a rapid but controlled fashion. This will be examined in a clinical population of 20 patients. This should provide initial data proving safety and will pave the way for a pivotal trial required by the FDA for this device.

描述（由申请人提供）：心肌梗死仍然是影响大量成年人的主要问题。在一系列的小动物实验中，已经表明，体温过低对损害的心脏的应用有益于降低梗塞大小。如果在再灌注前使心脏体温过低，则体温过低能够将梗塞大小降低超过50％。不幸的是，当最初在人类试验中检查了体温过低的治疗时，结果并不那么积极。然而，临床结果的分析表明，在再灌注前冷却的患者的一部分表明梗塞大小降低。再灌注后冷却的人没有显示出如此好处。因此，在AMI治疗的情况下，更快，更快的冷却方法引起了极大的兴趣。在过去的几年中，Life Recovery Systems HD，LLC一直在开发一种设备（Thremosuit。System），该设备可以比以前的非侵入性方法更快地产生体温过低。它可能以每小时超过8c0的速度以超过8c0的速度冷却成年人的整个身体。由于它是无创的，因此在与PCI的准备工作相关的典型延迟期（经皮冠状动脉介入式干预）的典型延迟期间，它也能够在急诊室迅速建立。此外，它有可能将其制造到便携式系统中，即使是早期的应用程序。在此应用中，我们建议在再灌注之前临床评估热诉系统在冷却AMI患者中的使用。这项20名患者的试验临床试验应证明可以达到治疗性低温（32至340C）的速度和易度性，无论该治疗是否会延迟挨家挨户的时间，以及在去除患者后保持目标温度的容易程度从西装。结果还将对与历史治疗方法相比是否引入任何其他安全性问题，对是否引入任何其他安全问题进行初步评估。这项提出的研究除了对梗塞大小与再灌注温度的共同申请动物研究外，还将支持人类对心肌梗死的状况的FDA认可的关键试验的批准。公共卫生相关性使用轻度体温过低以减少受伤后动物的梗塞大小，已有许多最近的调查检查。然而，尽管在小动物方面取得了成功，但临床结果并非阳性。假设可以降低温度的时间和速度是关键因素。本提案将应用一种可以快速但控制方式下降温度的设备。这将在20名患者的临床人群中进行检查。这应该提供最初的数据证明安全性，并将为FDA对该设备进行关键试验铺平道路。