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Neuroinflammation/Oxidative Stress/Cardiac Surgery

NCT ID: NCT06391866

Last Updated: 2024-04-30

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

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-30

Study Completion Date

2025-12-31

Brief Summary

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The prospective observational study delves into the complex relationship between neuroinflammation and oxidative stress in post-cardiac surgery complications, focusing on postoperative cognitive dysfunction.

Detailed Description

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The prospective observational study meticulously examines the interplay between neuroinflammation and oxidative stress in the realm of post-cardiac surgery complications, specifically targeting postoperative cognitive dysfunction. Its primary objective is to comprehensively assess the sustained influence of these intricate processes on cognitive function and overall well-being, extending beyond the immediate aftermath of surgery. The research endeavors to probe deeply into the molecular mechanisms and clinical ramifications associated with neuroinflammation and oxidative stress, centering on their pivotal role in shaping the onset and trajectory of postoperative cognitive dysfunction.

Conditions

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Neuroinflammation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Experimental group 1

Patients scheduled for elective cardiac surgery, such as coronary artery bypass grafting (CABG) or valve replacement, involving extracorporeal circulation (ECC) with a duration less than 60 minutes.

extracorporeal circulation

Intervention Type OTHER

extracorporeal circulation during cardiosurgical operation

Experimental group 2

Patients undergoing scheduled cardiac procedures, including coronary artery bypass grafting (CABG) or valve replacement, requiring extracorporeal circulation (ECC) for more than 60 minutes.

extracorporeal circulation

Intervention Type OTHER

extracorporeal circulation during cardiosurgical operation

Control group:

Patients scheduled for cardiac surgical procedures such as coronary artery bypass grafting (CABG) without extracorporeal circulation, and for carotid endarterectomy in neurologically asymptomatic patients prior to the procedure.

No interventions assigned to this group

Interventions

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extracorporeal circulation

extracorporeal circulation during cardiosurgical operation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Undergoing cardiosurgical operation
* Absence of previous neurological disease
* Signed informed consent document

Exclusion Criteria

* Presence of neoplasms
* Neurological Disease
* Refusal to participate in the clinical trial
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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East Slovak Institute for Cardiovascular Diseases

OTHER

Sponsor Role collaborator

Europainclinics z.ú.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Europainclinics

Košice, , Slovakia

Site Status RECRUITING

Countries

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Slovakia

Central Contacts

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Ladislav Kočan, MD, PhD, FIPP

Role: CONTACT

Phone: +421557891110

Email: [email protected]

Janka Vašková, prof. Dr. PhD.

Role: CONTACT

Email: [email protected]

Facility Contacts

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Ladislav Kočan, MD PhD

Role: primary

Other Identifiers

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NeuOX-postSurg Trial

Identifier Type: -

Identifier Source: org_study_id