Novel BIochemical Markers for Predicting Type 2 NEurological Complications of Surgical Coronary Revascularization (BINER): a Prospective Cohort Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Assessment of serum GFAP concentration (ng/ml) changes.
研究概览
简要总结
In this single center prospective cohort study a total of 100 patients scheduled for elective off-pump CABG will be recruited. They will be allocated to one study and one control group according to the presence or absence of postoperative type 2 neurological complications. The two groups will be compared in terms of serum concentrations of glial fibrillary acidic protein (GFAP), neuroserpin (NSP), phosphorylated axonal neurofilament subunit H (pNfH) and visinin-like protein 1 (VILIP-1) at the time of skin incision and closure as well as 24 hours and 7 days following surgery. Diagnostic performance of these markers for predicting type 2 neurological complications of off-pump CABG will be assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients scheduled for elective off-pump Coronary Artery Bypass Grafting (CABG)
排除标准
- •neurological or psychiatric disorders
- •alcohol or drug abuse
- •preoperative left ventricular ejection fraction of less than 30%
- •extracranial carotid artery stenosis of more than 70%
- •scoring below age- and education-adjusted cut-off values in Mini-Mental State Examination (MMSE)
- •scoring over seven points on the subscales of the Hospital Anxiety and Depression Scale (HADS)
结局指标
主要结局
Assessment of serum GFAP concentration (ng/ml) changes.
时间窗: GFAP concentrations will be measured preoperatively (at the time of initial skin incision), at the completion of surgery (at the time of skin closure) as well as 24 hours and 7 days following off-pump Coronary Artery Bypass Grafting (CABG).
Comparison of patients with and without type 2 neurological complications in respect to changes from baseline concentration of glial fibrillary acidic protein (GFAP).
Assessment of serum pNfH concentration (ng/ml) changes.
时间窗: pNfH concentrations will be measured preoperatively (at the time of initial skin incision), at the completion of surgery (at the time of skin closure) as well as 24 hours and 7 days following off-pump Coronary Artery Bypass Grafting (CABG).
Comparison of patients with and without type 2 neurological complications in respect to changes from baseline concentration of neuroserpin phosphorylated axonal neurofilament subunit H (pNfH).
Assessment of serum NSP concentration (ng/ml) changes.
时间窗: NSP concentrations will be measured preoperatively (at the time of initial skin incision), at the completion of surgery (at the time of skin closure) as well as 24 hours and 7 days following off-pump Coronary Artery Bypass Grafting (CABG).
Comparison of patients with and without type 2 neurological complications in respect to changes from baseline concentration of neuroserpin (NSP).
Assessment of serum VILIP-1 concentration (ng/ml) changes.
时间窗: VILIP-1 concentrations will be measured preoperatively (at the time of initial skin incision), at the completion of surgery (at the time of skin closure) as well as 24 hours and 7 days following off-pump Coronary Artery Bypass Grafting (CABG).
Comparison of patients with and without type 2 neurological complications in respect to changes from baseline concentration of visinin-like protein 1 (VILIP-1).
次要结局
未报告次要终点
研究者
Krzysztof Szwed
Principal Investigator
Collegium Medicum w Bydgoszczy