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| ID | Type | Description | Link |
|---|---|---|---|
| GCIRB2024-003 | Other Identifier | Gachon University Gil Medical Center IRB |
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This study evaluates Heuron CTA, a software that helps doctors detect blockages in brain blood vessels using CT angiography images. The software's results will be compared with diagnoses made by medical specialists to assess its accuracy. If it performs well, it may help doctors diagnose these conditions more quickly and effectively.
This study aims to evaluate the efficacy of Heuron CTA in assisting the diagnosis of suspected large vessel occlusion using brain CT angiography. The study will determine whether Heuron CTA meets the predefined clinical success criteria, where the lower bound of the 95% confidence interval for sensitivity and specificity exceeds 80%, using the final clinical diagnosis by a group of surgeons as the reference standard. If Heuron CTA meets the success criteria, it will be considered effective in assisting in the diagnosis of large vessel occlusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive Group | Diagnosed with large vessel occlusion due to occlusion of the vessels between ICA and MCA-M1 after taking brain CTA images |
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| Negative group | Diagnosed as either not having large vessel occlusion or as normal after brain CTA images |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heuron CTA | Device | This software automatically analyzes Computed Tomography Angiography (CTA) images to detect suspected large vessel occlusion, assisting surgeons in their diagnostic decisions |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity of Heuron CTA in determining the presence of suspected large vessel occlusion | Sensitivity and specificity of Heuron CTA in determining the presence of suspected large vessel occlusion were assessed by calculating their 95% confidence intervals (CIs) and determining whether the lower bound exceeded the clinical success criterion of 80%. The Clopper-Pearson confidence interval method12) was used to calculate the 95% CI. | Within 8 weeks after collecting data |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy, ROC Curve and AUC value for classifying suspected large vessel occlusion | Using the calculation method above, the accuracy for classifying suspected large vessel occlusion with a 95% confidence interval. The accuracy calculation method is the following: 100 × [TP + TN] / N. A ROC Curve was generated with the x-axis representing the false positive rate (1-specificity) and the y-axis representing sensitivity. The AUC value was calculated as the area under the ROC curve, with a 95% confidence interval provided. |
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Inclusion Criteria:
Adults aged 19 years or older who visited the clinical trial institution for brain CTA images between January 2020 and May 2021, and from November 2021 until IRB approval
Individuals classified into the positive or negative group based on the following criteria:
Exclusion Criteria:
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(1) Adults over 19 years old (2) Brain CTA images acquired (3) who confirmed with large vessel occlusion(positive group) or not large vessel occlusion or normal(negative group)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gachon University Gil Medical Center | Incheon | Namdong-gu | 21565 | South Korea |
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| Within 8 weeks after collecting data |
| Sensitivity of Heuron CTA in determining suspected large vessel occlusion for each occluded vessel | For the positive group, Sensitivity of Heuron CTA in determining suspected large vessel occlusion for each occluded vessel was calculated, along with a 95% confidence interval. | Within 8 weeks after collecting data |
| Sensitivity and specificity of Heuron CTA in determining suspected large vessel occlusion based on adjusted occlusion criteria | When the reference standard categories of None, Stenosis but not near occlusion, and Near occlusion were classified as "Large Vessel Occlusion Negative," and Occlusion was classified as "Large Vessel Occlusion Positive," the sensitivity and specificity of Heuron CTA were calculated along with a 95% confidence interval. | Within 8 weeks after collecting data |