Ischemic StrokeNCT04983927
Evaluation of Clinical Decision Support System for Scoring of ASPECT Score Using Brain CT Images
An observational study of Ischemic Stroke, run by Heuron Inc. at 1 site in South Korea.
Trial summary
cASPECTS is a software that has been pre-learned based on ASPECTS Score of ischemic stroke patients using brain CT images, and clinical decision support system for scoring ASPECTS score by automatically analyzing brain CT images by assisting the medical team. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- cASPECTS
- Type of treatment
- Medical device
- How many people
- 326 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Aug 2021to 6 Dec 2021
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: (1) Adults over 19 years old (2) Brain CT acquired are confirmed to be enrolled
Who may be able to join
- Adults over 19 years old
- Brain CT acquired
Who cannot join
- Patients with ischemic stroke in posterior circulation
- Poor or incomplete brain CT image quality
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Gachon University Gil Medical Center
Incheon, Namdong-gu, 21565
About this study
Official title: An Open Label, Single-center, Retrospective, Pivotal Study to Evaluate the Efficacy of Clinical Decision Support System for Scoring of ASPECT Score Using Brain CT Images
cASPECTS is a software that has been pre-learned based on ASPECTS Score of ischemic stroke patients using brain CT images, and clinical decision support system for scoring ASPECTS score by automatically analyzing brain CT images by assisting the medical team.
The specific aims of this study are to evaluate efficacy of cASPECTS for scoring ASPECTS Score compared to the sensitivity and specificity levels of human expert.
- Conditions
- Ischemic Stroke
- Being tested
- cASPECTS
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cASPECTSDevice
Clinical decision support system for scoring ASPECTS score
| Study group | Role | What they receive |
|---|---|---|
| Ischemic stroke positive | Patients diagnosed with acute ischemic stroke after a brain CT scan Receives: Device: cASPECTS | |
| Ischemic stroke negative with other brain disease | Patients who has not been diagnosed with acute ischemic stroke after a brain CT scan, but has been diagnosed with other brain diseases. Receives: Device: cASPECTS | |
| Ischemic stroke negative and no brain disease | Patients who has not been diagnosed with acute ischemic stroke after a brain CT scan and has not been diagnosed with other brain diseases. Receives: Device: cASPECTS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences between ASPECTS scores in golden standard and in cASPECTS
Mean difference between ASPECTS scores calculated by human experts and ASPECTS scores calculated by cASPECTS
Measured: Within 4 weeks after collecting data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start11 Aug 2021
- Primary completion6 Dec 2021
- Study completion6 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heuron Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daehan Choi, Principal investigator, Gachon University Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04983927
- Sponsor's protocol ID
- HR-cASP-01
- Status last verified
- Jan 2022
- First submitted
- 29 Jul 2021
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single-center, Retrospective, Pivotal Study to Evaluate the Efficacy of Clinical Decision Support System for Scoring of ASPECT Score Using Brain CT Images
- ClinicalTrials.gov ID
- NCT04983927
- Acronym / sponsor ID
- HR-cASP-01
- Conditions
- Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- Heuron Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Aug 2021 (actual)
- Primary completion
- 6 Dec 2021 (actual)
- Study completion
- 6 Dec 2021 (actual)
- First posted
- 30 Jul 2021 (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.
cASPECTS is a software that has been pre-learned based on ASPECTS Score of ischemic stroke patients using brain CT images, and clinical decision support system for scoring ASPECTS score by automatically analyzing brain CT images by assisting the medical team.
The specific aims of this study are to evaluate efficacy of cASPECTS for scoring ASPECTS Score compared to the sensitivity and specificity levels of human expert.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ischemic stroke positive | – | Device: cASPECTSPatients diagnosed with acute ischemic stroke after a brain CT scan |
| Ischemic stroke negative with other brain disease | – | Device: cASPECTSPatients who has not been diagnosed with acute ischemic stroke after a brain CT scan, but has been diagnosed with other brain diseases. |
| Ischemic stroke negative and no brain disease | – | Device: cASPECTSPatients who has not been diagnosed with acute ischemic stroke after a brain CT scan and has not been diagnosed with other brain diseases. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- (1) Adults over 19 years old (2) Brain CT acquired are confirmed to be enrolled
Key inclusion criteria (2 listed)
- Adults over 19 years old
- Brain CT acquired
Key exclusion criteria (2 listed)
- Patients with ischemic stroke in posterior circulation
- Poor or incomplete brain CT image quality
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 |
|---|---|---|
| cASPECTSClinical decision support system for scoring ASPECTS score | Device | Ischemic stroke negative and no brain disease, Ischemic stroke negative with other brain disease, Ischemic stroke positive |
Primary outcome
Differences between ASPECTS scores in golden standard and in cASPECTS
Time frame: Within 4 weeks after collecting data
Mean difference between ASPECTS scores calculated by human experts and ASPECTS scores calculated by cASPECTS
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 14 Jan 2022.
- 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.
Daehan Choi principal investigator
Gachon University Gil Medical Center
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 Ischemic Stroke, run by Heuron Inc. at 1 site in South Korea.
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 2 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 14 Jan 2022. 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 South Korea. 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?
Differences between ASPECTS scores in golden standard and in cASPECTS (time frame: Within 4 weeks after collecting data). 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 14 Jan 2022.