NCT03919370

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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 18, 2019

Completed
1.5 years until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

4.3 years

First QC Date

April 5, 2019

Last Update Submit

February 4, 2026

Conditions

Ischemic StrokeArtery OcclusionArtery Carotid StenosiIschemia, CerebralAnesthesiaSurgery

Outcome Measures

Primary Outcomes (5)

  • Heart Rate variability

    Changes in Heart Rate Variability from baseline.

    2020-2030

  • Near infrared spectroscopy

    Changes in Near Infrared spectroscopy from baseline.

    2020-2030

  • Electroencephalography

    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

    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

    Changes in levels of biomarkers in blood from baseline. Troponin T

    2020-2030

Study Arms (3)

Cerebral ischemia

Patients undergoing planned surgery for carotid stenosis

Other: No intervention

Reperfusion

Patients undergoing cerebral trombectomy.

Other: No intervention

Anaesthesia and surgery

Patients without preexisting cerebral injury undergoing abdominal surgery and anaesthesia

Other: No intervention

Interventions

No interventionOTHER

there will be NO intervention

Anaesthesia and surgeryCerebral ischemiaReperfusion

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

See above

You may qualify if:

  • Patients planned for carotid surgery or trombectomy
  • Giving informed consent to participate

You may not qualify if:

  • Patients that do not consent Patients with arrythmia or pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University hospital

Gothenburg, Sweden, 41345, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 32533722BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Brain IschemiaIschemic StrokeArterial Occlusive DiseasesCarotid Stenosis

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesStrokeCarotid Artery Diseases

Study Officials

  • Linda Block, PhD

    Inst Clin Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctor, MD, PhD

Study Record Dates

First Submitted

April 5, 2019

First Posted

April 18, 2019

Study Start

October 1, 2020

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

February 6, 2026

Record last verified: 2026-02

Locations

SE(1)