Clinical Trials Directory

Trials / Completed

CompletedNCT03919370

Detection of Cerebral Ischemia With Artificial Intelligence.

Detection of Cerebral Ischemia With Artificial Intelligence- Biomarkers as Indicators in Controlled Cerebral Ischemia and Reperfusion.

Status
Completed
Phase
Study type
Observational
Enrollment
60 (actual)
Sponsor
Linda Block · Academic / Other
Sex
All
Age
18 Years – 100 Years
Healthy volunteers
Not accepted

Summary

In patients undergoing planned surgery for carotid tromendarterendectomy, a non-invasive device that registers heart rate variability is attached. Furthermore a non-invasive device that monitors cerebral oxygenation- near infrared spectroscopy as well as electroencephalography is also attached. At times when surgeons clamps the carotid artery, there will be a moment with controlled cerebral ischemia. This will be registered by the devices. The information obtained will be used to teach artificial intelligence what patterns are related to cerebral ischemia. The same procedure will be performed in patients undergoing ocklusive cerebral trombectomy, so the artificial intelligence will learn to recognize cerebral reperfusion.Blood samples will be drawn before and after cerebral ischemia may occur and will be analyzed for neurobiomarkers and cardiac biomarkers. To teach the algorithm patterns from anaesthesia and surgery in patients without pre existing neuronal injury, the same method will be applied to patients undergoing mixed abdominal surgery. This group will provide a better knowledge of neuro biomarker patterns during anesthesia and surgery.

Detailed description

The neurobiomarkers that will be analyzed for detection of cerebral ischemia is Glial Fibrillary Acidic Protein, Neurofilament light chains, S-100B, Neuron specific endolas, Total-tau. Cardiac biomarkers are troponin-t and NT-pro brain natriuretic peptide. Blood sampling will occur before anesthesia induction and 2 and 24 hours after surgery or plausible ischemia for patients undergoing surgery for carotid endarterectomy. For patients undergoing acute thrombectomy blood sampling will be performed as soon as possible after the patient has arrived to the hospital as well as 2 hours and 24 hours later. For patients undergoing mixed abdominal surgery, sampling will be done before anesthesia induction and 2 hours and 24 hours after surgery. Additionally, blood from the thrombectomy cohort and the control cohort will be analyzed by an external party OLIMK, Uppsala. This is an explorative study aiming to find new biomarkers for detection of cerebral ischemia. Blood from both cohorts will be analyzed for 384 neurology biomarkers.

Conditions

Interventions

TypeNameDescription
OTHERNo interventionthere will be NO intervention

Timeline

Start date
2020-10-01
Primary completion
2024-12-31
Completion
2024-12-31
First posted
2019-04-18
Last updated
2026-02-06

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT03919370. Inclusion in this directory is not an endorsement.