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

NCT03493256 | Completed

• 1 other identifier: KB 776/2017
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurological Complication of Procedure (Disorder)

Outcome Measures

Primary Outcomes (4)

• 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).

Study Arms (2)

type 2 neurological complications present

The group of patients diagnosed with postoperative cognitive dysfunction (POCD) or postoperative delirium (POD), or both concurrently.

Other: exposure to type 2 neurological complications

type 2 neurological complications absent

The group of patients without neurological complications.

Interventions

exposure to type 2 neurological complications OTHER

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

type 2 neurological complications present

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• patients scheduled for elective off-pump Coronary Artery Bypass Grafting (CABG)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Collegium Medicum w Bydgoszczy: lead

Study Sites (1)

Department of Cardiac Surgery, Dr Antoni Jurasz Memorial University Hospital

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

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum

Study Officials

• Krzysztof Szwed, Dr

  Department of Clinical Neuropsychology, Nicolaus Copernicus University, Collegium Medicum.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: April 10, 2018
• Study Start: April 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Available without time limits.
• Access Criteria: The data that support the findings of this study are available from the corresponding author upon reasonable request.

Locations

PL (1)