Detection of Cerebral Ischemia With Artificial Intelligence.

NCT ID: NCT03919370

Last Updated: 2026-02-06

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

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-01

Study Completion Date

2024-12-31

Brief Summary

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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

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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

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cerebral ischemia

Patients undergoing planned surgery for carotid stenosis

No intervention

Intervention Type OTHER

there will be NO intervention

Reperfusion

Patients undergoing cerebral trombectomy.

No intervention

Intervention Type OTHER

there will be NO intervention

Anaesthesia and surgery

Patients without preexisting cerebral injury undergoing abdominal surgery and anaesthesia

No intervention

Intervention Type OTHER

there will be NO intervention

Interventions

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No intervention

there will be NO intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Göteborg University

OTHER

Sponsor Role collaborator

Linda Block

OTHER

Sponsor Role lead

Responsible Party

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Linda Block

Doctor, MD, PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Linda Block, PhD

Role: PRINCIPAL_INVESTIGATOR

Inst Clin Sciences

Locations

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Sahlgrenska University hospital

Gothenburg, Sweden, Sweden

Site Status

Countries

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Sweden

References

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Block L, El-Merhi A, Liljencrantz J, Naredi S, Staron M, Odenstedt Herges H. Cerebral ischemia detection using artificial intelligence (CIDAI)-A study protocol. Acta Anaesthesiol Scand. 2020 Oct;64(9):1335-1342. doi: 10.1111/aas.13657. Epub 2020 Jul 2.

Reference Type BACKGROUND
PMID: 32533722 (View on PubMed)

Other Identifiers

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CIDAI-BAS

Identifier Type: -

Identifier Source: org_study_id

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