Clinical trial NCT03493256: Novel BIochemical Markers for Predicting Type 2 NEurological Complications of Surgical Coronary Revascularization (BINER)
Official title: Novel BIochemical Markers for Predicting Type 2 NEurological Complications of Surgical Coronary Revascularization (BINER): a Prospective Cohort Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurological Complication of Procedure (Disorder)
Lead sponsor: Collegium Medicum w Bydgoszczy
Sponsor class: OTHER
First posted: 2018-04-10
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All participants will be recruited from patients scheduled for elective off-pump CABG at the Department of Cardiac Surgery, Dr Antoni Jurasz Memorial University Hospital, Bydgoszcz, Poland.

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Assessment of serum GFAP concentration (ng/ml) changes.
timeFrame: 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).
measure: Assessment of serum NSP concentration (ng/ml) changes.
timeFrame: 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).
measure: Assessment of serum pNfH concentration (ng/ml) changes.
timeFrame: 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).
measure: Assessment of serum VILIP-1 concentration (ng/ml) changes.
timeFrame: 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).
Secondary outcomes:
Other outcomes:
Locations:
city: Bydgoszcz
country: Poland
facility: Department of Cardiac Surgery, Dr Antoni Jurasz Memorial University Hospital
state: Kujawsko-Pomorskie
Study officials:
affiliation: Department of Clinical Neuropsychology, Nicolaus Copernicus University, Collegium Medicum.
name: Krzysztof Szwed, Dr
role: PRINCIPAL_INVESTIGATOR
References: