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Detection of Cerebral Ischemia With Artificial Intelligence. (CIDAI-BAS)

L

Linda Block

Status

Completed

Conditions

Ischemic Stroke
Artery Carotid Stenosi
Artery Occlusion
Ischemia, Cerebral
Surgery
Anesthesia

Treatments

Other: No intervention

Study type

Observational

Funder types

Other

Identifiers

NCT03919370
CIDAI-BAS

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients planned for carotid surgery or trombectomy
  • Giving informed consent to participate

Exclusion criteria

  • Patients that do not consent Patients with arrythmia or pacemaker

Trial design

60 participants in 3 patient groups

Cerebral ischemia
Description:
Patients undergoing planned surgery for carotid stenosis
Treatment:
Other: No intervention
Reperfusion
Description:
Patients undergoing cerebral trombectomy.
Treatment:
Other: No intervention
Anaesthesia and surgery
Description:
Patients without preexisting cerebral injury undergoing abdominal surgery and anaesthesia
Treatment:
Other: No intervention

Trial contacts and locations

2

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Central trial contact

Linda Block, PhD

Data sourced from clinicaltrials.gov

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