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

Neurological Complication of Procedure (Disorder) Clinical Trial

— BINER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03493256
• Other study ID #: KB 776/2017
• Status: Completed
• Start date: April 1, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: February 2020
• Source: Collegium Medicum w Bydgoszczy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Neurological Complication of Procedure (Disorder)

Intervention

Other:
• exposure to type 2 neurological complications
exposure to postoperative cognitive dysfunction (POCD) or postoperative delirium (POD), or both concurrently.

Locations

Country	Name	City	State
Poland	Department of Cardiac Surgery, Dr Antoni Jurasz Memorial University Hospital	Bydgoszcz	Kujawsko-Pomorskie

Sponsors (1)

Lead Sponsor	Collaborator
Collegium Medicum w Bydgoszczy

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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).
Primary	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).
Primary	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).