Continuation of the NuMoM2b Heart Health Study

NuMoM2b 心脏健康研究的延续

• 批准号: 10338143
• 负责人: Philip Greenland
• 金额: $ 280.04万
• 依托单位: RESEARCH TRIANGLE INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-02-15 至 2027-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10338143
• 关键词: Address; Age; Ancillary Study; Behavioral; Biometry; Birth; Cardiac health; Cardiology; Cardiovascular Diseases; Cardiovascular system; Cerebrovascular Disorders; Cessation of life; Clinical; Clinical Data; Cohort Studies; Data; Data Collection; Development; Diabetes Mellitus; Enrollment; Environment; Foundations; Future; Geography; Gestational Diabetes; Goals; Grant; Hypertension; Incidence; Incidence Study; Infrastructure; Investigation; Kidney Diseases; Knowledge; Leadership; Link; Maternal-fetal medicine; Mediating; Metabolic syndrome; Morbidity - disease rate; Obesity; Observational Study; Pattern; Persons; Phenotype; Physical activity; Pregnancy; Premature Birth; Prevention; Prevention strategy; Process; Recurrence; Resource Sharing; Resources; Risk Factors; Schedule; Scientist; Sleep Apnea Syndromes; Small for Gestational Age Infant; Smoking; Structure; Time; United States; United States National Institutes of Health; Vision; Visit; Woman; adverse pregnancy outcome; cardiovascular disorder risk; cohort; ethnic diversity; experience; follow-up; indexing; infrastructure development; mortality; multimodality; nutrition; patient engagement; pregnancy hypertension; prospective; reproductive; risk prediction; stillbirth; success; treatment strategy

PROJECT SUMMARY/ABSTRACT Cardiovascular disease (CVD) is the leading cause of mortality and morbidity in U.S. women at all ages, and large knowledge gaps exist in CVD predictive and preventive strategies for women. The nuMoM2b Heart Health Study (nuMoM2b-HHS) has followed a demographically diverse cohort of 4,475 women enrolled and richly phenotyped during their first pregnancy, with data and biospecimens prospectively collected for up to 7 years thereafter. The overarching scientific goal of the nuMoM2b-HHS is to define the relationship between adverse pregnancy outcomes (APOs) and CVD to optimize CVD prediction, prevention, and treatment strategies for women. Continued follow-up of this cohort, building on a foundation of existing high-quality data, biospecimens, and administrative structures with a robust framework for ancillary study development and implementation, provides a unique opportunity to address knowledge gaps regarding the early mechanisms and trajectory of CVD in women. We propose to continue nuMoM2b-HHS follow-up through semiannual contacts and an in-person visit to assess CVD risk factors during grant years 3-5 (Aim 1). Accumulated longitudinal data and biospecimens will serve as a broadly accessible platform for ancillary studies to identify early mechanisms of CVD and to address additional NIH priority domains including early manifestations of cerebrovascular and renal disease in reproductive-age women. Ancillary studies (Aim 2) will expand data collection during the follow-up contacts and in-person visit, and add to the planned contact schedule, to permit the effective targeting of knowledge gaps required to optimize predictive and preventive strategies. The Specific Aims reflect a multifaceted approach to the study of the incidence and mechanisms of CVD development in women of reproductive age, focusing on the incidence of CVD risk factors in women with and without APOs (Aim 3); the associations between atherogenic phenotypes and sleep-disordered breathing during and after pregnancy and estimated CVD risk 6-15 years later (Aims 4 and 5, respectively); and identification of modifiable factors that influence or moderate these associations (Aim 6). This application has several strengths that reflect the potential for long-term success of the cohort: (1) The nuMoM2b-HHS will be led by three deeply experienced PIs with complementary domains of expertise in cardiology, maternal-fetal medicine, and biostatistics. (2) The network has robust infrastructure in place to maintain long-term participant engagement and support rigorous data collection. (3) The cohort's high-quality data and biospecimens have been collected under regulatory frameworks that support resource sharing and use in future research. (4) The network has established processes for successfully proposing, reviewing, and implementing ancillary studies. This foundation of strong leadership, robust administrative and operational infrastructure, and actualized long-term vision will provide an ideal environment for the nuMoM2b-HHS to continue to address critical knowledge gaps concerning CVD development in women of reproductive age.

项目概要/摘要 心血管疾病 (CVD) 是美国各个年龄段女性死亡和发病的主要原因，并且 女性心血管疾病预测和预防策略方面存在巨大的知识差距。 nuMoM2b 心脏 健康研究 (nuMoM2b-HHS) 对 4,475 名女性进行了跟踪调查，并 在第一次怀孕期间具有丰富的表型，前瞻性地收集了多达 7 次的数据和生物样本 此后的几年。 nuMoM2b-HHS 的总体科学目标是定义之间的关系 不良妊娠结局 (APO) 和 CVD，以优化 CVD 预测、预防和治疗 女性战略。在现有高质量的基础上继续跟踪这一群体 数据、生物样本和管理结构，以及用于辅助研究开发的强大框架 和实施，提供了一个独特的机会来解决早期的知识差距 女性CVD的机制和轨迹。我们建议通过以下方式继续 nuMoM2b-HHS 后续行动： 在资助的第 3-5 年期间，每半年进行一次接触和亲自访问，以评估 CVD 风险因素（目标 1）。 积累的纵向数据和生物样本将作为辅助工具的广泛访问平台 研究旨在确定 CVD 的早期机制并解决其他 NIH 优先领域，包括早期 育龄妇女脑血管和肾脏疾病的表现。辅助研究（目标 2） 将在后续接触和亲自访问期间扩大数据收集，并添加到计划的接触中 时间表，以便有效地瞄准优化预测和预防所需的知识差距 策略。具体目标反映了研究发病率和机制的多方面方法 育龄妇女 CVD 发展情况，重点关注女性 CVD 危险因素的发生率 有和没有 APO（目标 3）；致动脉粥样硬化表型与睡眠障碍之间的关联 怀孕期间和怀孕后的呼吸情况以及 6-15 年后估计的 CVD 风险（分别为目标 4 和 5）； 并确定影响或调节这些关联的可改变因素（目标 6）。 该应用程序有几个优点，反映了该队列长期成功的潜力：(1) nuMoM2b-HHS 将由三位经验丰富的 PI 领导，他们在以下领域具有互补的专业知识领域： 心脏病学、母胎医学和生物统计学。 (2) 网络基础设施健全 保持参与者的长期参与并支持严格的数据收集。 （三）师资队伍素质高 数据和生物样本是在支持资源共享和支持的监管框架下收集的 在未来的研究中使用。 (4) 网络建立了成功提案、审查和批准的流程 实施辅助研究。这是强有力的领导、强有力的行政和运营的基础 基础设施和实现的长期愿景将为 nuMoM2b-HHS 提供理想的环境 继续解决有关育龄妇女 CVD 发展的关键知识差距。