Continuation of the NuMoM2b Heart Health Study

NuMoM2b 心脏健康研究的延续

• 批准号: 10200499
• 负责人: Philip Greenland
• 金额: $ 238.96万
• 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: 2020-05-15 至 2027-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10200499
• 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; Participant; 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; pregnancy hypertension; prospective; reproductive; 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.

项目总结/摘要 心血管疾病（CVD）是美国所有年龄段女性死亡和发病的主要原因， 妇女在心血管疾病预测和预防策略方面存在巨大的知识差距。nuMoM 2b心脏 健康研究（nuMoM 2b-HHS）跟踪了一个人口统计学上多样化的队列，共有4，475名女性入组， 在第一次怀孕期间进行了丰富的表型分析，前瞻性收集了多达7 几年后。nuMoM 2b-HHS的首要科学目标是定义以下之间的关系 不良妊娠结局（APO）和CVD，以优化CVD预测、预防和治疗 妇女战略。在现有的高质量的基础上，继续对这一组进行跟踪。 数据、生物标本和行政结构，以及用于辅助研究开发的强大框架 提供了一个独特的机会，以解决知识差距， 女性CVD的机制和轨迹。我们建议通过以下方式继续nuMoM 2b-HHS随访 每半年进行一次接触，并在第3-5年（目标1）期间进行一次面对面访问，以评估CVD风险因素。 积累的纵向数据和生物标本将作为一个广泛访问的平台， 研究以确定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临床表现。辅助研究（目标2） 将在随访联系和亲自访视期间扩大数据收集，并将其添加到计划联系中 时间表，以便能够有效地针对优化预测和预防所需的知识差距， 战略布局具体目标反映了研究发病率和机制的多方面方法 育龄妇女心血管疾病的发展，重点是妇女心血管疾病危险因素的发病率 有和没有载脂蛋白O（目的3）;动脉粥样硬化表型和睡眠障碍之间的关系 怀孕期间和怀孕后的呼吸以及6-15年后估计的心血管疾病风险（分别为目标4和5）; 并确定影响或缓和这些关联的可改变因素（目标6）。 该应用程序具有几个优势，反映了队列长期成功的潜力：（1） nuMoM 2b-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： 心脏病学、母胎医学和生物统计学。(2)该网络拥有强大的基础设施， 保持参与者的长期参与并支持严格的数据收集。(3)这群人的素质很高 在支持资源共享的监管框架下收集数据和生物标本， 用于未来的研究。(4)该网络建立了成功提出、审查和 进行辅助研究。这一强有力的领导、有力的行政和业务基础 基础设施和实现的长期愿景将为nuMoM 2b-HHS提供理想的环境， 继续解决有关育龄妇女心血管疾病发展的关键知识差距。