Detection and Neurological Impact of Cerebrovascular Events in Cardiac Surgery Patients: A Cohort Evaluation Pilot (NeuroVISION Cardiac Pilot)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Lost to follow-up
研究概览
简要总结
The investigators conducted a prospective observational pilot study to explore the incidence of peri-operative covert strokes (detected by brain MRI) and the potential impact on delirium and cognitive decline in post-operative cardiac surgery patients at the Hamilton General Hospital. This pilot study assessed the feasibility of a larger prospective international cohort study exploring this objective.
详细描述
Delirium and cognitive decline are common following cardiac surgery and increase the burden on patients and health care resources. Covert (sub-clinical) strokes are associated with these complications. The investigators conducted a prospective cohort pilot study enrolling consecutive cardiac surgery patients to receive a post-operative brain MRI and a series of questionnaires to assess for changes in cognition, physical function and delirium. Regional cerebral oxygen saturation (rSO2) was recorded during surgery with the use of near-infrared spectroscopy (NIRS) sensors placed on the patients' forehead. The primary aim was to determine the feasibility of conducting a larger study to establish an association between covert stroke and long-term cognitive decline in cardiac surgery patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 21 years old
- •Provide written informed consent
- •Scheduled to undergo isolated CABG through a median sternotomy approach
- •Have at least one of the following risk factors:
- •Peripheral vascular disease (previous peripheral arterial bypass, amputation due to ischemia, ABPI <0.9, or previous AAA repair)
- •Cerebrovascular disease (history of stroke, TIA, or carotid stenosis >70%)
- •Renal insufficiency (eGFR <60 mL/min/1.73m2)
- •Diabetes mellitus (on oral hypoglycemic agent(s) and/or insulin replacement)
- •Urgent CABG (in-patient awaiting revascularization for ACS or MI)
- •Recent smoker (within the last year)
- •Left ventricular ejection fraction <35%
排除标准
- •Concomitant cardiac procedure with CABG Prior enrolment in this study
- •Emergency CABG surgery (immediate revascularization for hemodynamic instability)
- •Circulatory arrest planned during the cardiac operation
- •Diagnosed dementia of any types
- •Contra-indication for DW MRI e.g. claustrophobia, unable to lie flat for the duration of the study, pacemaker or ICD in-situ, or other metal implants
结局指标
主要结局
Lost to follow-up
时间窗: 3 months
Proportion of patients lost to follow-up at the end of the study
Recruitment rate
时间窗: 30 days
Average recruitment rate per week
MRI completion
时间窗: 30 days
Total number of patients completing the brain MRI study
次要结局
- Physical function(3 months)
- Covert stroke(30 days)
- Clinical stroke(30 days)
- Cognitive decline (MoCA)(30 days)
- Cognitive decline (DSST)(30 days)
- Delirium(day 2 to 30 day, whichever comes first)