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

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.