Novel BIochemical Markers for Predicting Type 2 NEurological Complications of Surgical Coronary Revascularization (BINER)

Collegium Medicum w Bydgoszczy100 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Neurological Complication of Procedure (Disorder)

Interventions

exposure to type 2 neurological complicationsOTHER

exposure to postoperative cognitive dysfunction (POCD) or postoperative delirium (POD), or both concurrently.

Medical Language ↔ Plain English

Inclusion Criteria: * patients scheduled for elective off-pump Coronary Artery Bypass Grafting (CABG) Exclusion Criteria: * 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)

Outcomes

Primary Outcomes

Assessment of serum GFAP concentration (ng/ml) changes.

Comparison of patients with and without type 2 neurological complications in respect to changes from baseline concentration of glial fibrillary acidic protein (GFAP).

Time frame: 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).

Assessment of serum NSP concentration (ng/ml) changes.

Comparison of patients with and without type 2 neurological complications in respect to changes from baseline concentration of neuroserpin (NSP).

Time frame: 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).

Assessment of serum pNfH concentration (ng/ml) changes.

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).

Time frame: 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).

Assessment of serum VILIP-1 concentration (ng/ml) changes.

Comparison of patients with and without type 2 neurological complications in respect to changes from baseline concentration of visinin-like protein 1 (VILIP-1).

Time frame: 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).