Ischemia, CerebralCIDAI-BASNCT03919370
Detection of Cerebral Ischemia With Artificial Intelligence.
An observational study of Ischemia, Cerebral and Ischemic Stroke, run by Linda Block at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Ischemia, Cerebral, Ischemic Stroke, Artery Occlusion
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 1 Oct 2020to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: See above
Who may be able to join
- Patients planned for carotid surgery or trombectomy
- Giving informed consent to participate
Who cannot join
- Patients that do not consent Patients with arrythmia or pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Ischemia, Cerebral, Ischemic Stroke, Artery Occlusion, Artery Carotid Stenosi, Anesthesia, Surgery
- Being tested
- No intervention
- Medical subject headings
- Brain Ischemia, Ischemic Stroke, Arterial Occlusive Diseases, Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
there will be NO intervention
| Study group | Role | What they receive |
|---|---|---|
| Cerebral ischemia | Patients undergoing planned surgery for carotid stenosis Receives: Other: No intervention | |
| Reperfusion | Patients undergoing cerebral trombectomy. Receives: Other: No intervention | |
| Anaesthesia and surgery | Patients without preexisting cerebral injury undergoing abdominal surgery and anaesthesia Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate variability
Changes in Heart Rate Variability from baseline.
Measured: 2020-2030
Near infrared spectroscopy
Changes in Near Infrared spectroscopy from baseline.
Measured: 2020-2030
Electroencephalography
Changes in electroencephalography from baseline, more precisely the Power in alpha bands, beta band, delta bands and quotas between these.
Measured: 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.
Measured: 2020-2030
Biomarkers indicating cardiac ischemia in blood
Changes in levels of biomarkers in blood from baseline. Troponin T
Measured: 2020-2030
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start1 Oct 2020
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemia, CerebralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linda Block
- Sponsor type
- University, hospital or other
- Collaborators
- Göteborg University
- Responsible party
- Sponsor-investigator, Linda Block, Göteborg University
- Investigators
- Linda Block, PhD, Principal investigator, Inst Clin Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03919370
- Sponsor's protocol ID
- CIDAI-BAS
- Acronym
- CIDAI-BAS
- Status last verified
- Oct 2026
- First submitted
- 5 Apr 2019
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32533722
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Cerebral Ischemia With Artificial Intelligence- Biomarkers as Indicators in Controlled Cerebral Ischemia and Reperfusion.
- ClinicalTrials.gov ID
- NCT03919370
- Acronym / sponsor ID
- CIDAI-BAS / CIDAI-BAS
- Conditions
- Ischemia, Cerebral, Ischemic Stroke, Artery Occlusion, Artery Carotid Stenosi, Anesthesia, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Linda BlockUniversity, hospital or other
- Collaborators
- Göteborg University
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 18 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cerebral ischemia | – | Other: No interventionPatients undergoing planned surgery for carotid stenosis |
| Reperfusion | – | Other: No interventionPatients undergoing cerebral trombectomy. |
| Anaesthesia and surgery | – | Other: No interventionPatients without preexisting cerebral injury undergoing abdominal surgery and anaesthesia |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- See above
Key inclusion criteria (2 listed)
- Patients planned for carotid surgery or trombectomy
- Giving informed consent to participate
Key exclusion criteria (1 listed)
- Patients that do not consent Patients with arrythmia or pacemaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionthere will be NO intervention | Other | Anaesthesia and surgery, Cerebral ischemia, Reperfusion |
Primary outcome
Heart Rate variability
Time frame: 2020-2030
Changes in Heart Rate Variability from baseline.
Near infrared spectroscopy
Time frame: 2020-2030
Changes in Near Infrared spectroscopy from baseline.
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.
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.
Biomarkers indicating cardiac ischemia in blood
Time frame: 2020-2030
Changes in levels of biomarkers in blood from baseline. Troponin T
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Background: PubMed 32533722Block 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.
- Individual participant dataSharing planned: Undecided
Related trials for Ischemia, Cerebral
Recruiting
Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe
Stroke, Acute
Not yet recruiting
EEG Feedback-Based Vagus Nerve Stimulation for Post-Stroke Dysphagia
Ischemic Stroke, Post-stroke Dysphagia
RecruitingObservational study
Development and Validation of Risk Prediction Models for Stroke and Cognitive Impairment in Moyamoya Disease and Moyamoya Syndrome
Moyamoya Disease, Moyamoya Syndrome
Recruiting
Impact of Atrial Fibrosis Surface Area on the Occurrence of Atrial Fibrillation in Patients With Ischemic Stroke of Undetermined Origin: a Prospective Cardiac MRI Pilot Study.
Stroke, Implantation of an Implantable Cardiac Monitor
Recruiting
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)
Brainstem Stroke, ALS
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Block, PhD principal investigator
Inst Clin Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemia, Cerebral and Ischemic Stroke, run by Linda Block at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate variability (time frame: 2020-2030). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03919370, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.