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出境医 / 临床实验 / Detection of Cerebral Ischemia With Artificial Intelligence. (CIDAI-BAS)

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

Study Description
Brief 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.


Condition or disease Intervention/treatment
Ischemia, Cerebral Ischemic Stroke Artery Occlusion Artery Carotid Stenosi Other: No intervention

Detailed Description:

Please see the published study protocol for details.

The neurobiomarkers that will be analyzed for detection of cerebral ischemia is Glial Fibrillary Acidic Protein, Neurofilament light chains, S-100, 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 hours after plausible ischemia for patients undergoung surgery for carotid endarterectomy. for patients undergoing acute thrombectomy blood sampling will be performed as soon as possible after patient has arrived to the hospital.

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detection of Cerebral Ischemia With Artificial Intelligence- Biomarkers as Indicators in Controlled Cerebral Ischemia and Reperfusion.
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022
Arms and Interventions
Group/Cohort Intervention/treatment
Cerebral ischemia
Patients undergoing planned surgery for carotid stenosis
 Other: No intervention
there will be NO intervention
Reperfusion
Patients undergoing cerebral trombectomy.
 Other: No intervention
there will be NO intervention
Outcome Measures
Primary Outcome Measures :
  1. Heart Rate variability [ Time Frame: 2020-2022 ]
    Changes in Heart Rate Variability from baseline.

  2. Near infrared spectroscopy [ Time Frame: 2020-2022 ]
    Changes in Near Infrared spectroscopy from baseline.

  3. Electroencephalography [ Time Frame: 2020-2022 ]
    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: 2020-2022 ]
    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: 2020-2022 ]
    Changes in levels of biomarkers in blood from baseline. Troponin T


Biospecimen Retention:   Samples Without DNA
Blood

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
See above
Criteria

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
Contacts and Locations

Contacts
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Contact: Linda Block, PhD +46313428173 linda.block@vgregion.se

Locations
Layout table for location information
Sweden
Sahlgrenska University hospital Recruiting
Gothenburg, Sweden, 41345
Contact: Linda Block, PhD    +46313428173    linda.block@vgregion.se   
Sponsors and Collaborators
Linda Block
Göteborg University
Investigators
Layout table for investigator information
Principal Investigator: Linda Block, PhD Inst Clin Sciences
Tracking Information
First Submitted Date April 5, 2019
First Posted Date April 18, 2019
Last Update Posted Date November 16, 2020
Actual Study Start Date October 1, 2020
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 13, 2020)
  • Heart Rate variability [ Time Frame: 2020-2022 ]
    Changes in Heart Rate Variability from baseline.
  • Near infrared spectroscopy [ Time Frame: 2020-2022 ]
    Changes in Near Infrared spectroscopy from baseline.
  • Electroencephalography [ Time Frame: 2020-2022 ]
    Changes in electroencephalography from baseline, more precisely the Power in alpha bands, beta band, delta bands and quotas between these.
  • Biomarkers indicating cerebral ischemia in blood [ Time Frame: 2020-2022 ]
    Changes in levels of biomarkers in blood from baseline. Total tau, neurofilament light chains, glial fibrillary acidic protein, S-100, neuron specific endolas.
  • Biomarkers indicating cardiac ischemia in blood [ Time Frame: 2020-2022 ]
    Changes in levels of biomarkers in blood from baseline. Troponin T
Original Primary Outcome Measures
 (submitted: April 15, 2019)
  • Heart Rate variability [ Time Frame: 2019-2021 ]
    The aim of the study is to investigate if Heart Rate Variability can be processed with artificial intelligence to predict imminent cerebral ischemia.
  • Near infrared spectroscopy [ Time Frame: 2019-2021 ]
    The aim of the study is to investigate if signals from Near Infrared spectroscopy can be processed with artificial intelligence to predict imminent cerebral ischemia.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Detection of Cerebral Ischemia With Artificial Intelligence.
Official Title Detection of Cerebral Ischemia With Artificial Intelligence- Biomarkers as Indicators in Controlled Cerebral Ischemia and Reperfusion.
Brief 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.
Detailed Description

Please see the published study protocol for details.

The neurobiomarkers that will be analyzed for detection of cerebral ischemia is Glial Fibrillary Acidic Protein, Neurofilament light chains, S-100, 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 hours after plausible ischemia for patients undergoung surgery for carotid endarterectomy. for patients undergoing acute thrombectomy blood sampling will be performed as soon as possible after patient has arrived to the hospital.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Blood
Sampling Method Probability Sample
Study Population See above
Condition
  • Ischemia, Cerebral
  • Ischemic Stroke
  • Artery Occlusion
  • Artery Carotid Stenosi
Intervention Other: No intervention
there will be NO intervention
Study Groups/Cohorts
  • Cerebral ischemia
    Patients undergoing planned surgery for carotid stenosis
    Intervention: Other: No intervention
  • Reperfusion
    Patients undergoing cerebral trombectomy.
    Intervention: Other: No intervention
Publications * Block L, El-Merhi A, Liljencrantz J, Naredi S, Staron M, Odenstedt Hergès 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 13, 2020) 		20
Original Estimated Enrollment
 (submitted: April 15, 2019) 		10
Estimated Study Completion Date December 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Linda Block, PhD +46313428173 linda.block@vgregion.se
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT03919370
Other Study ID Numbers CIDAI-BAS
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Linda Block, Göteborg University
Study Sponsor Linda Block
Collaborators Göteborg University
Investigators
Principal Investigator: Linda Block, PhD Inst Clin Sciences
PRS Account Göteborg University
Verification Date November 2020

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