Stroke, IschemicSMART-LVONCT06216457
Study on the Performance of a Machine Learning Algorithm Recognizing and Triaging Large Vessel Occlusions Using Non-contrast CT Scans
An observational study of Stroke, Ischemic and Stroke Hemorrhagic, run by Methinks Software SL.
Trial summary
The goal of this prospective observational study is to assess the effectiveness and performance of Methinks AI stroke imaging software platform in acute Code Stroke patients, and as a comparator to study sites utilizing existing AI imaging stroke platforms. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Stroke, Ischemic, Stroke Hemorrhagic, Stroke, Acute
- What is being tested?
- AI software for Stroke
- Type of treatment
- Medical device
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 31 Oct 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive Code Stroke patients, aged 22 or older, regardless of presence or absence of ultimate diagnosis of Ischemic Stroke or Hemorrhagic Stroke.
Who may be able to join
- Subjects with acute neurological symptoms suggestive of Stroke, ischemic or hemorrhagic ("Code Stroke"), regardless of presence or absence of final Stroke diagnosis.
- Subjects aged 22 years or older.
- NCCT performed for Code Stroke screening.
- If the patient does not have a hemorrhage, a CTA (head and neck, performed for Code Stroke screening) should also be performed.
- NCCT and CTA have been processed by Methinks AI software.
Who cannot join
- ● Subject imaging does not meet Image Acquisition and DICOM Tag Requirements
Trial locations and contacts
No sites are listed yet.
About this study
The goal of this prospective observational study is to assess the effectiveness and performance of Methinks AI stroke imaging software platform in acute Code Stroke patients, and as a comparator to study sites utilizing existing AI imaging stroke platforms.
The main question[s] it aims to answer is:
- Performance of and outcomes associated with the use of the Methinks AI stroke imaging medical device in real-world clinical practice.
Read the detailed description
This is a prospective observational medical device clinical trial that aims to assess the diagnostic performance of Methinks Investigational Device on detecting LVO and ICH on plain NCCT and CTA, in consecutive acute Code Stroke activations at the emergency department.
Demographic, Clinical and Imaging variables will be collected from stroke onset through Day 7 or Discharge, whichever is earlier. Methinks results will be collected exclusively for research purposes and no clinical decisions will be made based on the output. Diagnostic performance of NCCT-LVO Methinks output will be assessed using DSA and/or CTA as ground truth. Presence of ICH will be assessed using an independent neuroradiologist final reading. The Clinical impact on workflow will be retrospectively estimated based on the reduction of time to decision in both transfer patients and the ones directly arriving to the emergency department (ED)
Informed consent forms (ICF) will be waived, as approved by the IRB.
- Conditions
- Stroke, Ischemic, Stroke Hemorrhagic, Stroke, Acute, Brain Ischemia
- Being tested
- AI software for Stroke
- Medical subject headings
- Ischemic Stroke, Hemorrhagic Stroke, Stroke, Brain Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI software for StrokeDevice
Also called Methinks AI Software
AI Software for Non-Contrast Head CT (Computed Tomography) and CT Angiography, utilized for Code Stroke screening, notification and triage.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: LVO | Subjects with Methinks NCCT algorithm detecting ICA, M1, and M2 occlusions. Receives: Device: AI software for Stroke | |
| Group 2: ICH | Subjects with Methinks NCCT algorithm detecting ICHs. Receives: Device: AI software for Stroke | |
| Group 3: Controls | Subjects with final diagnosis confirmed not to be Stroke (i.e. stroke mimic) or any type of stroke not determined to be: LVO (ICA, M1 or M2) or ICH. Receives: Device: AI software for Stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the sensitivity and specificity of the following Methinks AI modules:
- Methinks NCCT algorithm detecting ICA, M1, and M2 occlusions.
- Methinks NCCT algorithm detecting ICHs.
- Methinks CTA algorithm detecting ICA, M1, and M2 occlusions.
Measured: Baseline, pre-intervention (Code Stroke presentation and screening), During Code Stroke treatment, Immediately After the stroke treatment, Up to Discharge or 7 Days (whichever is sooner).
Secondary outcomes (3)
Time Potential time reduction - difference in speed to LVO notification between Methinks NCCT-LVO and competitor CTA-LVO.
Measured: Baseline, pre-intervention (Code Stroke presentation and screening), During Code Stroke treatment, Immediately After the stroke treatment, Up to Discharge or 7 Days (whichever is sooner).
Time for NCCT-LVO Notification.
Measured: Baseline, pre-intervention (Code Stroke presentation and screening), During Code Stroke treatment, Immediately After the stroke treatment, Up to Discharge or 7 Days (whichever is sooner).
User experience.
Site Principal Investigator will complete questionnaire based upon experience with use of the Methinks software and application.
Measured: 1 day (Questionnaire completed at individual site enrollment completion.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start1 Jul 2024 (estimated)
- Primary completion30 Jul 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies 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
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Methinks Software SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Santiago Ortega- global PI
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216457
- Sponsor's protocol ID
- SMART-LVO Registry
- Acronym
- SMART-LVO
- Status last verified
- May 2024
- First submitted
- 4 Jan 2024
- Last updated
- 29 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Performance of a Machine Learning Algorithm Recognizing and Triaging Large Vessel Occlusions Using Non-contrast CT Scans
- ClinicalTrials.gov ID
- NCT06216457
- Acronym / sponsor ID
- SMART-LVO / SMART-LVO Registry
- Conditions
- Stroke, Ischemic, Stroke Hemorrhagic, Stroke, Acute, Brain Ischemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Methinks Software SLIndustry (pharma, biotech, devices)
- Collaborators
- Santiago Ortega- global PI
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 22 Jan 2024 (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.
The goal of this prospective observational study is to assess the effectiveness and performance of Methinks AI stroke imaging software platform in acute Code Stroke patients, and as a comparator to study sites utilizing existing AI imaging stroke platforms.
The main question[s] it aims to answer is:
- Performance of and outcomes associated with the use of the Methinks AI stroke imaging medical device in real-world clinical practice.
Detailed description
This is a prospective observational medical device clinical trial that aims to assess the diagnostic performance of Methinks Investigational Device on detecting LVO and ICH on plain NCCT and CTA, in consecutive acute Code Stroke activations at the emergency department.
Demographic, Clinical and Imaging variables will be collected from stroke onset through Day 7 or Discharge, whichever is earlier. Methinks results will be collected exclusively for research purposes and no clinical decisions will be made based on the output. Diagnostic performance of NCCT-LVO Methinks output will be assessed using DSA and/or CTA as ground truth. Presence of ICH will be assessed using an independent neuroradiologist final reading. The Clinical impact on workflow will be retrospectively estimated based on the reduction of time to decision in both transfer patients and the ones directly arriving to the emergency department (ED)
Informed consent forms (ICF) will be waived, as approved by the IRB.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: LVO | – | Device: AI software for StrokeSubjects with Methinks NCCT algorithm detecting ICA, M1, and M2 occlusions. |
| Group 2: ICH | – | Device: AI software for StrokeSubjects with Methinks NCCT algorithm detecting ICHs. |
| Group 3: Controls | – | Device: AI software for StrokeSubjects with final diagnosis confirmed not to be Stroke (i.e. stroke mimic) or any type of stroke not determined to be: LVO (ICA, M1 or M2) or ICH. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive Code Stroke patients, aged 22 or older, regardless of presence or absence of ultimate diagnosis of Ischemic Stroke or Hemorrhagic Stroke.
Key inclusion criteria (5 listed)
- Subjects with acute neurological symptoms suggestive of Stroke, ischemic or hemorrhagic ("Code Stroke"), regardless of presence or absence of final Stroke diagnosis.
- Subjects aged 22 years or older.
- NCCT performed for Code Stroke screening.
- If the patient does not have a hemorrhage, a CTA (head and neck, performed for Code Stroke screening) should also be performed.
- NCCT and CTA have been processed by Methinks AI software.
Key exclusion criteria (1 listed)
- ● Subject imaging does not meet Image Acquisition and DICOM Tag Requirements
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 |
|---|---|---|
| AI software for StrokeAlso: Methinks AI SoftwareAI Software for Non-Contrast Head CT (Computed Tomography) and CT Angiography, utilized for Code Stroke screening, notification and triage. | Device | Group 1: LVO, Group 2: ICH, Group 3: Controls |
Primary outcome
Evaluate the sensitivity and specificity of the following Methinks AI modules:
Time frame: Baseline, pre-intervention (Code Stroke presentation and screening), During Code Stroke treatment, Immediately After the stroke treatment, Up to Discharge or 7 Days (whichever is sooner).
1. Methinks NCCT algorithm detecting ICA, M1, and M2 occlusions. 2. Methinks NCCT algorithm detecting ICHs. 3. Methinks CTA algorithm detecting ICA, M1, and M2 occlusions.
3 secondary outcomes
Time Potential time reduction - difference in speed to LVO notification between Methinks NCCT-LVO and competitor CTA-LVO.
Time frame: Baseline, pre-intervention (Code Stroke presentation and screening), During Code Stroke treatment, Immediately After the stroke treatment, Up to Discharge or 7 Days (whichever is sooner).
Time for NCCT-LVO Notification.
Time frame: Baseline, pre-intervention (Code Stroke presentation and screening), During Code Stroke treatment, Immediately After the stroke treatment, Up to Discharge or 7 Days (whichever is sooner).
User experience.
Time frame: 1 day (Questionnaire completed at individual site enrollment completion.)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Sponsor websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Ischemic and Stroke Hemorrhagic, run by Methinks Software SL.
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 5 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: status not confirmed, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlotta Calvi (+34639041147, research@methinks.ai), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the sensitivity and specificity of the following Methinks AI modules: (time frame: Baseline, pre-intervention (Code Stroke presentation and screening), During Code Stroke treatment, Immediately After the stroke treatment, Up to Discharge or 7 Days (whichever is sooner).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2024.