Detection of Cerebral Ischemia With Artificial Intelligence. (CIDAI-BAS)
Detection of Cerebral Ischemia With Artificial Intelligence- Biomarkers as Indicators in Controlled Cerebral Ischemia and Reperfusion.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Sweden
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Gothenburg, Sweden, Sweden, 41345
- Sahlgrenska University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Cerebral ischemia
Patients undergoing planned surgery for carotid stenosis
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there will be NO intervention
|
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Reperfusion
Patients undergoing cerebral trombectomy.
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there will be NO intervention
|
|
Anaesthesia and surgery
Patients without preexisting cerebral injury undergoing abdominal surgery and anaesthesia
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there will be NO intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart Rate variability
Time Frame: 2020-2030
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Changes in Heart Rate Variability from baseline.
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2020-2030
|
|
Near infrared spectroscopy
Time Frame: 2020-2030
|
Changes in Near Infrared spectroscopy from baseline.
|
2020-2030
|
|
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.
|
2020-2030
|
|
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.
|
2020-2030
|
|
Biomarkers indicating cardiac ischemia in blood
Time Frame: 2020-2030
|
Changes in levels of biomarkers in blood from baseline.
Troponin T
|
2020-2030
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Linda Block, PhD, Inst Clin Sciences
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIDAI-BAS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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