Randomized Comparison of the Clinical Outcome of Single Versus Multiple Arterial Grafts: Cognition (ROMA:Cog)

单动脉移植与多动脉移植临床结果的随机比较：认知 (ROMA:Cog)

• 批准号: 10689518
• 负责人: Mario FL Gaudino
• 金额: $ 83.99万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-06-15 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10689518
• 关键词: Acute; Address; Adult; Affect; Age; Alleles; American; Apolipoprotein E; Biological Markers; Brain; Brain Embolism; Brain Infarction; Cardiac; Cardiac Surgery procedures; Cerebrum; Clinical; Cognition; Cognitive; Coronary Artery Bypass; Coronary heart disease; Country; Data; Day Surgery; Dementia; Diabetes Mellitus; Diffusion Magnetic Resonance Imaging; Early Intervention; Evaluation; Event; Future; Genotype; Glial Fibrillary Acidic Protein; Goals; Impaired cognition; Impairment; Infarction; Inflammation; Infrastructure; International; Intervention; Language; Light; Magnetic Resonance Imaging; Measures; Multilingualism; Nerve Degeneration; Neuron-Specific Enolase; Neuronal Injury; Operative Surgical Procedures; Outcome; Participant; Patient Care; Patients; Persons; Postoperative Period; Public Health; Randomized; Representational Oligonucleotide Microarray Analysis; Research; Risk; Risk Factors; Sampling; Science; Screening procedure; Serum; Short-Term Memory; Site; Specific qualifier value; Stroke; Subgroup; Surgeon; Surrogate Endpoint; Techniques; Thromboembolism; Time; Vascular Cognitive Impairment; Woman; acute stroke; base; brain health; cognitive function; cognitive performance; cognitive testing; cohort; comorbidity; computerized; follow-up; men; mild cognitive impairment; neurofilament; novel; novel marker; prevent; programs; recruit; sex; tau Proteins; tau-1

Coronary heart disease affects over 18.2 million Americans and coronary artery bypass surgery (CABG) is the most common cardiac surgery in adults. Unfortunately, CABG is associated with stroke, cognitive impairment, and dementia, especially among women and patients with diabetes. As many as 25% of patients with a clinically uncomplicated postoperative course have evidence of brain emboli after CABG, and even small infarcts can unmask latent neurodegeneration and increase postoperative cognitive impairment. Intraoperative thromboembolism is one of the mechanisms contributing to cognitive impairment, due to surgical aortic manipulation. Less aortic manipulation is associated with less plaque dislodgement, resulting in fewer embolic events during cardiac surgery. The Randomized comparison of the clinical Outcome of single versus Multiple Arterial grafts: Cognition (ROMA:Cog) study will identify both the global impact of CABG surgery and the impact of acute infarction on cognitive function. The first aim addresses the impact of CABG surgical technique on long-term cognitive function in an international cohort of 2,000 participants who have been randomized to either a multiple arterial grafts or single arterial grafts groups and by important subgroups, including women and patients with diabetes. Results will either demonstrate differences in cognitive function or provide reassurance to cardiac surgeons that there are no differences in the proportion of patients with cognitive impairment by surgical technique. In the second and third aims, the short-term impact of CABG surgical technique will be determined based on domains of cognitive performance, and the associations among CABG surgical technique, cognitive performance, brain infarction and novel serum biomarkers of brain health in a cohort of 280 participants. Results will provide us with mechanistic details on the relationships between surgical technique, detailed cognitive performance, acute MRI indicated brain infarction, and novel biomarkers of brain health. Leveraging the international ROMA trial infrastructure, one of the largest cardiac surgery trials to date, we have an unprecedented opportunity to clarify the impact of CABG surgical technique on short and long-term cognitive function. Preventing postoperative cognitive impairment is an important public health concern that could be mitigated with specific surgical techniques. The ROMA:Cog study will help to identify people who could benefit from detailed cognitive evaluation and early interventions, and will establish whether serum biomarkers can be used as novel surrogate end-points in future studies to prevent vascular cognitive impairment.

冠心病影响超过1820万美国人，冠状动脉旁路手术（CABG）是治疗冠心病的最佳方法。 最常见的成人心脏手术不幸的是，冠状动脉旁路移植术与中风，认知障碍， 和痴呆症，尤其是女性和糖尿病患者。多达25%的患者在临床上 无并发症的术后病程有证据表明CABG术后存在脑栓塞，即使是小的梗死也可能 暴露潜在的神经变性并增加术后认知障碍。术中 血栓栓塞是主动脉手术导致认知障碍的机制之一 操纵较少的主动脉操作与较少的斑块移位相关，导致较少的栓塞 心脏手术期间发生的事件。单次与单次化疗临床疗效的随机比较 多动脉移植物：认知（ROMA：Cog）研究将确定CABG手术的全球影响 以及急性梗死对认知功能的影响。第一个目的是解决冠状动脉旁路移植术的影响， 长期认知功能的技术，在一个国际队列的2,000名参与者， 根据重要亚组随机分配到多动脉移植物组或单动脉移植物组， 包括女性和糖尿病患者。结果将显示认知功能的差异， 为心脏外科医生提供保证，在患有认知障碍的患者比例方面没有差异， 外科技术损伤。在第二和第三个目标中，CABG手术的短期影响 技术将根据认知表现的领域以及CABG之间的关联来确定 脑梗死患者的手术技术、认知能力、脑梗死和脑健康的新血清生物标志物 280名参与者。结果将为我们提供关于外科手术之间关系的机制细节。 技术，详细的认知表现，急性MRI显示脑梗死，以及脑的新生物标志物 健康利用国际ROMA试验基础设施，这是迄今为止最大的心脏手术试验之一， 我们有一个前所未有的机会来阐明CABG手术技术对短期和长期的影响， 认知功能预防术后认知障碍是一个重要的公共卫生问题， 可以通过特定的手术技术缓解。罗马：Cog研究将有助于确定那些可以 受益于详细的认知评估和早期干预，并将确定血清生物标志物是否 可以在未来的研究中用作新的替代终点，以预防血管性认知障碍。