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

Study Overview
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Brief Summary
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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.

Official Title
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Novel BIochemical Markers for Predicting Type 2 NEurological Complications of Surgical Coronary Revascularization (BINER): a Prospective Cohort Study.

Conditions
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Neurological Complication of Procedure (Disorder)

Intervention / Treatment
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* Other: exposure to type 2 neurological complications


Participation Criteria
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Eligibility Criteria
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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)
Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| type 2 neurological complications present<br>The group of patients diagnosed with postoperative cognitive dysfunction (POCD) or postoperative delirium (POD), or both concurrently. | Other: exposure to type 2 neurological complications<br>* exposure to postoperative cognitive dysfunction (POCD) or postoperative delirium (POD), or both concurrently.<br>|
| type 2 neurological complications absent<br>The group of patients without neurological complications. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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). | 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). | 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). |