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

NCT ID: NCT03493256

Last Updated: 2020-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-01

Study Completion Date

2019-03-01

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.

Detailed Description

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Conditions

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Neurological Complication of Procedure (Disorder)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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type 2 neurological complications present

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

exposure to type 2 neurological complications

Intervention Type OTHER

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

type 2 neurological complications absent

The group of patients without neurological complications.

No interventions assigned to this group

Interventions

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exposure to type 2 neurological complications

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

Intervention Type OTHER

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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Collegium Medicum w Bydgoszczy

OTHER

Sponsor Role lead

Responsible Party

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Krzysztof Szwed

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Krzysztof Szwed, Dr

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Department of Cardiac Surgery, Dr Antoni Jurasz Memorial University Hospital

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Site Status

Countries

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Poland

Other Identifiers

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KB 776/2017

Identifier Type: -

Identifier Source: org_study_id

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