Skip to main content
OpenTrials
Completed

NCT Number: NCT03919370

Detection of Cerebral Ischemia With Artificial Intelligence.

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ischemia, Cerebral Anesthesia Arterial Occlusive Diseases Artery Carotid Stenosi Artery Occlusion Brain Diseases Brain Ischemia Cardiovascular Diseases Carotid Artery Diseases Carotid Stenosis Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Surgery Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sahlgrenska University hospital

Gothenburg, Sweden, 41345

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

there will be NO intervention

Primary outcomes

  1. Heart Rate variability

    Time frame: 2020-2030

    Changes in Heart Rate Variability from baseline.

  2. Near infrared spectroscopy

    Time frame: 2020-2030

    Changes in Near Infrared spectroscopy from baseline.

  3. Electroencephalography

    Time frame: 2020-2030

    Changes in electroencephalography from baseline, more precisely the Power in alpha bands, beta band, delta bands and quotas between these.

  4. Biomarkers indicating cerebral ischemia in blood

    Time frame: 2020-2030

    Changes in levels of biomarkers in blood from baseline. Total tau, neurofilament light chains, glial fibrillary acidic protein, S-100, neuron specific endolas.

  5. Biomarkers indicating cardiac ischemia in blood

    Time frame: 2020-2030

    Changes in levels of biomarkers in blood from baseline. Troponin T

Sponsors and collaborators

Lead sponsor

Linda Block

Other

Collaborators

  • Göteborg University

Registry information

Official study title

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

Acronym: CIDAI-BAS

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Apr 18, 2019
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.