Remote monitoring of cardiac function in childhood cancer survivors

远程监测儿童癌症幸存者的心脏功能

• 批准号: 10456314
• 负责人: Saro Armenian
• 金额: $ 17.44万
• 依托单位: BECKMAN RESEARCH INSTITUTE/CITY OF HOPE
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10456314
• 关键词: Acoustics; Address; Adult; Age; Anthracycline; Biometry; Bluetooth; Breast Cancer survivor; COVID-19 pandemic; Cancer Center; Cancer Survivor; Cancer Survivorship; Cardiac; Cardiology; Cardiotoxicity; Cardiovascular system; Caring; Cellular Phone; Chest; Chronic Disease; Clinic; Clinical; Development; Devices; Diagnosis; Diagnostic; Diagnostic Imaging; Disease; Disease Management; Dose; EFRAC; Early Diagnosis; Echocardiography; Enrollment; Ensure; Face; Freedom; Guidelines; Healthcare; Heart Diseases; Heart Transplantation; Heart failure; High-Risk Cancer; Home; Immunotherapy; Knowledge; Left Ventricular Ejection Fraction; Long Term Survivorship; Long-Term Survivors; Longterm Follow-up; Lymphoma; Magnetic Resonance; Malignant Childhood Neoplasm; Measures; Medical; Monitor; Morbidity - disease rate; Myocardial dysfunction; Oncology; Outcome; Patients; Penetration; Periodicity; Persons; Pharmacology; Population; Prevention strategy; Prior Therapy; Radiation therapy; Reporting; Reproducibility; Research; Research Priority; Risk; Schools; Self Administration; Survivors; Technology; Testing; Time; Trastuzumab; Treatment-Related Cancer; Ventricular Remodeling; Visit; Work; base; biomechanical engineering; cancer risk; cancer therapy; cardiac magnetic resonance imaging; cardiovascular disorder risk; cardiovascular risk factor; childhood cancer survivor; clinical care; clinical development; clinically relevant; community setting; cost; cost effective; cost effectiveness; early screening; follow-up; health economics; heart function; heart imaging; imaging approach; mHealth; markov model; mobile computing; mortality; multidisciplinary; point of care; primary care setting; prospective; remote monitoring; response; routine screening; screening; standard of care; survivorship; wireless electronic

Abstract Cardiovascular complications are a leading cause of morbidity and mortality in survivors of childhood cancer. These survivors have a greater than four-fold risk of developing heart failure (HF) when compared to age- matched controls, and there is a strong dose-dependent association between anthracycline exposure and the risk of heart failure. Outcome following HF is poor, emphasizing the importance of early detection of cardiac dysfunction (e.g. abnormal left ventricular ejection fraction [EF]) with cardiac imaging and initiation of pharmacologic therapy prior to the development of clinically overt disease. Unfortunately, the period in time when survivors are at the greatest risk of HF also corresponds to the time when they are least engaged in risk- based survivorship care. New paradigms in clinical care and chronic disease management are needed for these survivors. Recent advances in mobile technology have facilitated the development of a new sector of mobile healthcare diagnostics (mHealth) that has the potential to combine the utility of standard of care cardiac monitoring by echocardiography with the accuracy of more advanced diagnostic imaging (cardiac magnetic resonance [CMR]). However, neither the reproducibility nor the cost-effectiveness of this mHealth technology for prospective clinic- or home-based cardiac monitoring in cancer survivors is known. To address these knowledge gaps, we will enroll 200 long-term childhood cancer survivors who previously underwent a one-time assessment of cardiac EF by echocardiography, CMR, and a handheld Bluetooth-enabled device (Vivio) to validate the accuracy of Vivio EF in the clinic setting, and to determine its reproducibility at home (Aim 1). We will also leverage the expertise of our investigative team to determine the cost-effectiveness of Vivio-based screening using Markov modeling (Aim 2). This study will: 1) provide an important follow-up timepoint that will confirm the accuracy of EF, as measured using Vivio, in anthracycline-exposed survivors; 2) demonstrate the reproducibility of self-administered home-based measures of cardiac function in survivors who may no longer be able to maintain survivorship-focused care at the cancer center; and 3) establish whether Vivio-based screening is a cost-effective alternative to current standard of care cardiac imaging approaches. Information obtained from the current study can be used to develop strategies that facilitate screening and management of cardiac dysfunction during cancer treatment, or after completion of therapy in other at-risk cancer populations (e.g. adult survivors of lymphoma treated with known cardiotoxic [anthracyclines, chest radiation] therapies or newer immunotherapies, adult survivors of breast cancer treated with anthracyclines and/or trastuzumab) who face similar challenges in long-term follow-up. The growing population of long-term cancer survivors at risk for cardiovascular disease makes development of screening and prevention strategies imperative, to ensure that these survivors live long and healthy lives well after completion of their cancer treatment.

抽象的 心血管并发症是儿童癌症幸存者发病和死亡率的主要原因。 与年龄相比 匹配的控件，蒽环类暴露与剂量依赖性关联 心力衰竭的风险。 HF之后的结果很差，强调了早期发现心脏的重要性 功能障碍（例如异常的左心室射血分数[EF]），并具有心脏成像和启动 在发展临床明显疾病之前，药理治疗。不幸的是，时间段 当幸存者处于最大的HF风险时，也对应于他们从事风险最小的时间 - 基于生存护理。需要新的临床护理和慢性疾病管理范式 这些幸存者。移动技术的最新进展有助于发展 移动医疗诊断（MHealth）有可能结合护理标准心脏的实用性 通过超声心动图进行监测，具有更先进的诊断成像的准确性（心脏磁性 共振[CMR]）。但是，这种MHealth技术的可重复性和成本效益既不 对于癌症幸存者中的前瞻性诊所或家庭心脏监测，众所周知。解决这些 知识差距，我们将招募200个长期儿童癌症幸存者 通过超声心动图，CMR和手持蓝牙设备（Vivio）评估心脏EF的评估 验证Vivio EF在临床环境中的准确性，并确定其在家中的可重复性（AIM 1）。我们 还将利用我们的调查团队的专业知识来确定基于Vivio的成本效益 使用马尔可夫建模进行筛选（AIM 2）。这项研究将：1）提供重要的后续时间点 确认使用Vivio测量的EF的准确性，在暴露于蒽环类的幸存者中； 2）演示 自我管理的家庭功能的可重复性在幸存者中可能不再 能够在癌症中心维持以生存为重点的护理； 3）确定是否基于Vivio 筛选是当前护理标准心脏成像方法的经济高效替代方法。信息 从当前研究获得的可用于制定促进筛查和管理的策略 癌症治疗期间的心脏功能障碍，或在其他高危癌症种群中完成治疗后 （例如，已知心脏毒性[蒽环类药物，胸部辐射]疗法治疗的淋巴瘤成年幸存者或 较新的免疫疗法，接受蒽环类药物和/或曲妥珠单抗治疗的乳腺癌的成年幸存者） 在长期随访中面临类似的挑战。长期癌症幸存者的人口不断增长 心血管疾病使得必须制定筛查和预防策略，以确保 这些幸存者在完成癌症治疗后悠久而健康。