Randomized comparison of the clinical Outcome of single versus Multiple Arterial grafts: Cognition (ROMA:Cog)

单动脉移植物与多动脉移植物临床结果的随机比较：认知 (ROMA:Cog)

• 批准号: 10279790
• 负责人: Mario FL Gaudino
• 金额: $ 83.51万
• 依托单位: WEILL MEDICAL COLL OF CORNELL UNIV
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-15 至 2022-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10279790
• 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; 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.

冠心病影响着超过1820万美国人，而冠状动脉旁路手术(CABG)是 成人最常见的心脏手术。不幸的是，CABG与中风、认知障碍、 和痴呆症，特别是在妇女和糖尿病患者中。多达25%的临床上患有 不复杂的术后病程有CABG后脑血栓的证据，即使是小的梗塞也可以。 揭露潜伏性神经变性，增加术后认知功能障碍。术中 血栓栓塞症是主动脉外科手术导致认知功能障碍的机制之一 操纵。较少的主动脉操作与较少的斑块移位相关，从而导致较少的血栓形成。 心脏手术期间发生的事件。单项治疗与单纯治疗临床结局的随机对照研究 多动脉移植物：认知(ROMA：COG)研究将确定CABG手术的全球影响 以及急性脑梗塞对认知功能的影响。第一个目标是解决冠状动脉旁路移植术的影响 一项关于长期认知功能的技术在2000名国际队列参与者中进行 随机分为多动脉移植物组或单动脉移植物组以及按重要的子组， 包括妇女和糖尿病患者。结果要么显示认知功能的差异，要么显示 向心脏外科医生保证，认知障碍患者的比例没有差异 外科技术造成的损害。在第二和第三个目标中，冠状动脉旁路移植术的短期影响 技术将根据认知表现领域和冠脉搭桥术之间的关联来确定 手术技术、认知功能、脑梗塞和脑健康的新血清生物标记物 280名参与者组成的队列。结果将为我们提供外科手术之间关系的机制细节 技术，详细的认知表现，急性核磁共振显示脑梗塞，以及新的脑生物标记物 健康。利用国际罗姆试验基础设施，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 可以通过特定的外科手术技术来缓解。罗姆：COG研究将有助于确定哪些人可能 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 可在未来的研究中用作预防血管认知障碍的新的替代终点。