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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03919370
Recruitment Status : Recruiting
First Posted : April 18, 2019
Last Update Posted : January 25, 2022
Sponsor:
Collaborator:
Göteborg University
Information provided by (Responsible Party):
Linda Block, Göteborg University

Study Description
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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
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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 2025
Estimated Study Completion Date : December 2026
Groups and Cohorts
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03919370


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

Locations
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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
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Principal Investigator: Linda Block, PhD Inst Clin Sciences
More Information
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Publications:

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Responsible Party: Linda Block, Doctor, MD, PhD, Göteborg University
ClinicalTrials.gov Identifier: NCT03919370    
Other Study ID Numbers: CIDAI-BAS
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: January 25, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ischemic Stroke
Brain Ischemia
Cerebral Infarction
Carotid Stenosis
Ischemia
Pathologic Processes
Stroke
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Infarction
Necrosis
Carotid Artery Diseases
Arterial Occlusive Diseases