Early Imaging Detection of CV Injury after Cancer

描述(申请人提供)：心血管(CV)损伤导致心肌梗死(MI)、心源性死亡、中风和充血性心力衰竭(CHF)是基于蒽环类药物的化疗用于辅助乳腺癌、白血病和淋巴瘤治疗的主要障碍。对于需要这种疗法的儿童或成人，目前还没有临床上可以接受的替代疗法。聚集在一起的学术-产业团队将开发和优化一个具有成本效益的、自动化的、可重复使用的硬件/软件平台，该平台可以获取、分析和报告亚临床和临床心血管损伤，识别这种损伤的机制，并预测心血管事件风险。这一重要信息可用于临床前治疗。 当应用于其他心血管高危人群时，可降低不良心血管事件的发生率。这项设计良好、动力强大的关键临床研究将验证这些技术：“在接触蒽环类药物之前以及暴露后3个月和24个月收集人体内的纵向结果，以确定短期结果是否预示着预示不良预后的长期亚临床疾病……确定这一新平台在10至80岁的儿童和成人中的疗效~”派生人口(年龄、性别、种族、与现有的多种族动脉粥样硬化研究(MESA)中6,000名未发现冠状动脉疾病的患者相比，该平台的预测指标实现了标准化，从而使世界各地几乎没有MRI专业知识的医疗中心能够可靠且可重复地进行研究。这一平台创新基于强大的NCI资助的初步数据，为以前未解决的临床问题提供了一种非常重要的成本效益解决方案，该解决方案以非侵入性方式定义早期心血管风险，并使有针对性的治疗干预能够大幅降低这些风险。减少癌症幸存者的心血管事件将降低癌症患者的总体发病率 并提高与癌症相关的存活率。

DESCRIPTION (provided by applicant): Cardiovascular (CV) injury leading to myocardial infarction (MI), cardiac death, stroke, and congestive heart failure (CHF) is a major impediment to the curative use of anthracycline-based chemotherapy for the treatment of adjuvant breast cancer, leukemia, and lymphoma. No clinically acceptable alternatives exist for children or adults that require this therapy. The assembled academic-industrial team will develop and optimize a cost-effective, automated, reproducible hardware/software platform that acquires, analyzes, and reports subclinical and clinical CV injury, identifies the mechanisms of this injury and forecasts CV event risks. This important information can be utilized for preclinical treatment protocols that, when administered to other high CV risk populations, reduce the rates of adverse CV events. This well-designed and powered pivotal clinical study to validate these technologies will: " Collect within person longitudinal results before anthracycline exposure and at 3 and 24 months after exposure to determine if short-term results predict long-term subclinical disease that portends an adverse prognosis~ " Determine the efficacy of this new platform in children and adults aged 10 to 80 years~ " Derive population (age, gender, race, and cardiac risk factor-matched) predictive metrics for the platform compared against 6,000 individuals without known coronary artery disease from the existing Multi-Ethnic Study of Atherosclerosis (MESA)~ " Standardize the automated platform to enable medical centers throughout the world with little MRI expertise to reliably and reproducibly perform the studies. This platform innovation is based on strong NCI funded preliminary data and provides a highly significant cost effective solution for a previously unsolved clinical problem that noninvasively defines early CV risk and enables targeted therapeutic interventions to dramatically reduce these risks. Reducing CV events in cancer survivors will reduce overall morbidity in patients with cancer and improve cancer-related survival.