CIDAI-BAS: Detection of Cerebral Ischemia With Artificial Intelligence.

Sponsor

Linda Block (Other)

Overall Status

Recruiting

CT.gov ID

NCT03919370

Collaborator

Göteborg University (Other)

Enrollment

Location

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

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	Phase
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

Study Type:

Observational

Anticipated 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 :

Oct 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2026

Arms and Interventions

Arm	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

Arm

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

Heart Rate variability [2020-2022]
Changes in Heart Rate Variability from baseline.
Near infrared spectroscopy [2020-2022]
Changes in Near Infrared spectroscopy from baseline.
Electroencephalography [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 [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 [2020-2022]
Changes in levels of biomarkers in blood from baseline. Troponin T

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Sahlgrenska University hospital	Gothenburg		Sweden	41345

Sponsors and Collaborators

Linda Block
Göteborg University

Investigators

Principal Investigator: Linda Block, PhD, Inst Clin Sciences

Study Documents (Full-Text)

None provided.

More Information

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.

Responsible Party:

Linda Block, Doctor, MD, PhD, Göteborg University

ClinicalTrials.gov Identifier:

NCT03919370

Other Study ID Numbers:

CIDAI-BAS

First Posted:

Apr 18, 2019

Last Update Posted:

Jan 25, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 25, 2022