Completed

NCT Number: NCT03493256

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

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.

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Key information

Conditions

Neurological Complication of Procedure (Disorder)

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Cardiac Surgery, Dr Antoni Jurasz Memorial University Hospital

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-094, Poland

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

exposure to type 2 neurological complications

Other

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

Primary outcomes

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

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).

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 NSP concentration (ng/ml) changes.

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).

Comparison of patients with and without type 2 neurological complications in respect to changes from baseline concentration of neuroserpin (NSP).
Assessment of serum pNfH concentration (ng/ml) changes.

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).

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 VILIP-1 concentration (ng/ml) changes.

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).

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

Sponsors and collaborators

Lead sponsor

Collegium Medicum w Bydgoszczy

Other

Registry information

Official study title

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

Acronym: BINER

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Apr 10, 2018
Registry last updated: Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.