NeuroinflammationNEuOX-postSURgNCT06391866
Neuroinflammation/Oxidative Stress/Cardiac Surgery
An observational study of Neuroinflammation, run by EPC Education s.r.o. at 1 site in Slovakia.
Trial summary
The prospective observational study delves into the complex relationship between neuroinflammation and oxidative stress in post-cardiac surgery complications, focusing on postoperative cognitive dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Neuroinflammation
- What is being tested?
- extracorporeal circulation
- How many people
- 60 participants
- Where
- 1 siteSlovakia
- Study dates
- 30 Apr 2024to 31 Dec 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Adult
Study population: Patient undergoing cardiac surgery
Who may be able to join
- Undergoing cardiosurgical operation
- Absence of previous neurological disease
- Signed informed consent document
Who cannot join
- Presence of neoplasms
- Neurological Disease
- Refusal to participate in the clinical trial
Trial locations and contacts
1 site in 1 country.
Janka Vašková, prof. Dr. PhD. contact
Slovakia1 site, 1 recruiting
- Recruiting
Europainclinics
Košice, 04011
Ladislav Kočan, MD PhD
About this study
Official title: Assessing Neuroinflammation and Oxidative Stress After Cardiac Surgery: Unveiling Molecular Dynamics and Clinical Outcomes
The prospective observational study delves into the complex relationship between neuroinflammation and oxidative stress in post-cardiac surgery complications, focusing on postoperative cognitive dysfunction.
Read the detailed description
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
- Neuroinflammation
- Being tested
- extracorporeal circulation
- Medical subject headings
- Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extracorporeal circulationOther
extracorporeal circulation during cardiosurgical operation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: extracorporeal circulation | |
| 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. Receives: Other: extracorporeal circulation | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and type of early complications after surgery
Estimating of postoperative complications
Measured: 1 month
Number and type of postoperative complications
Estimating of postoperative complications
Measured: 6 months
Secondary outcomes (4)
Estimating biochemical parameters
Pro-inflammatory interleukins parameters (e.g. IL-8, IL-6, MIP-1a, MMP-2, MMP-9, SIRT 1, SIRT 2)
Measured: 1 hour
Estimating biochemical parameters
Pro-inflammatory interleukins
Measured: 6 hours
Estimating biochemical parameters Third biochemical examination
Antioxidative enzymes
Measured: 1 hour
Estimating biochemical parameters
Antioxidative enzymes
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start30 Apr 2024 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeuroinflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- EPC Education s.r.o.
- Sponsor type
- University, hospital or other
- Collaborators
- East Slovak Institute for Cardiovascular Diseases
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391866
- Sponsor's protocol ID
- NeuOX-postSurg Trial
- Acronym
- NEuOX-postSURg
- Status last verified
- Apr 2024
- First submitted
- 17 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After completing data collection, the data will be made available to the ethical committees of interested institutions
Publications
Kocan L, Sudzina R, Kocanova H, Zavacka M, Pobehova J, Rybar D, Dudova M, Ferencik M, Vaskova J. Early Cognitive Outcomes After Carotid Endarterectomy in Asymptomatic Stenosis: A Pilot Study. Cureus. 2025 Nov 11;17(11):e96559. doi: 10.7759/cureus.96559. eCollection 2025 Nov.
PubMed 41393743
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Neuroinflammation and Oxidative Stress After Cardiac Surgery: Unveiling Molecular Dynamics and Clinical Outcomes
- ClinicalTrials.gov ID
- NCT06391866
- Acronym / sponsor ID
- NEuOX-postSURg / NeuOX-postSurg Trial
- Conditions
- Neuroinflammation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- EPC Education s.r.o.University, hospital or other
- Collaborators
- East Slovak Institute for Cardiovascular Diseases
- Study start
- 30 Apr 2024 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental group 1 | – | Other: extracorporeal circulationPatients 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. |
| Experimental group 2 | – | Other: extracorporeal circulationPatients undergoing scheduled cardiac procedures, including coronary artery bypass grafting (CABG) or valve replacement, requiring extracorporeal circulation (ECC) for more than 60 minutes. |
| 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Patient undergoing cardiac surgery
Key inclusion criteria (3 listed)
- Undergoing cardiosurgical operation
- Absence of previous neurological disease
- Signed informed consent document
Key exclusion criteria (3 listed)
- Presence of neoplasms
- Neurological Disease
- Refusal to participate in the clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| extracorporeal circulationextracorporeal circulation during cardiosurgical operation | Other | Experimental group 1, Experimental group 2 |
Primary outcome
Number and type of early complications after surgery
Time frame: 1 month
Estimating of postoperative complications
Number and type of postoperative complications
Time frame: 6 months
Estimating of postoperative complications
4 secondary outcomes
Estimating biochemical parameters
Time frame: 1 hour
Estimating biochemical parameters
Time frame: 6 hours
Estimating biochemical parameters Third biochemical examination
Time frame: 1 hour
Estimating biochemical parameters
Time frame: 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Derived from this study: PubMed 41393743Kocan L, Sudzina R, Kocanova H, Zavacka M, Pobehova J, Rybar D, Dudova M, Ferencik M, Vaskova J. Early Cognitive Outcomes After Carotid Endarterectomy in Asymptomatic Stenosis: A Pilot Study. Cureus. 2025 Nov 11;17(11):e96559. doi: 10.7759/cureus.96559. eCollection 2025 Nov.
- Individual participant dataSharing planned: Undecided. After completing data collection, the data will be made available to the ethical committees of interested institutions
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janka Vašková, prof. Dr. PhD. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroinflammation, run by EPC Education s.r.o. at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ladislav Kočan, MD, PhD, FIPP (+421557891110, europainclinicsstudy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and type of early complications after surgery (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06391866, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.