AI-Based Tools for Stroke Diagnosis, Treatment and Outcome Prediction: a Multicentre Prospective Observational Study
NCT07924371, Recruiting, Hospital Universitari Vall d'Hebron Research Institute
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | AI-Based Tools for Stroke Diagnosis, Treatment and Outcome Prediction: a Multicentre Prospective Observational Study | ClinicalTrials.gov |
| NCT number | NCT07924371 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Enrollment | 10,000 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Hospital Universitari Vall d'Hebron Research Institute | ClinicalTrials.gov |
| Conditions | Stroke, Ischemic Stroke, Intracerebral Hemorrhage, Transient Ischemic Attack, Atrial Fibrillation | ClinicalTrials.gov |
| Interventions | Standard of care (no study intervention) | ClinicalTrials.gov |
| First posted | 2026-11-09 | ClinicalTrials.gov |
| Last updated | 2026-11-09 | ClinicalTrials.gov |
Registered outcomes 17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Area Under the Curve (AUC) of the Pre-hospital AI Model for Detection of Large Vessel Occlusion (LVO) Stroke (WP2) | At hospital admission (Day 1) | Discriminative performance (area under the receiver operating characteristic curve, with 95% CI) of the pre-hospital AI model for identifying LVO stroke, using the final in-hospital diagnosis as the reference standard. | ClinicalTrials.gov |
| Primary | AUC of the Image-based AI Tool for Prediction of Successful Reperfusion After Endovascular Thrombectomy (WP3) | Day 1 (at the end of the endovascular procedure) | Discriminative performance (area under the receiver operating characteristic curve, with 95% CI) of the image-based AI tool for predicting successful reperfusion, defined as expanded Thrombolysis in Cerebral Infarction (eTICI) grade 2b-3 on final angiography. | ClinicalTrials.gov |
| Primary | AUC of the AI Model for Prediction of Early Hematoma Expansion in Intracerebral Hemorrhage (WP4) | 24 hours after admission | Discriminative performance (area under the receiver operating characteristic curve, with 95% CI) of the AI model for predicting hematoma expansion on follow-up imaging compared with baseline imaging. | ClinicalTrials.gov |
| Primary | C-statistic of the AI Risk Model for Prediction of Recurrent Stroke After TIA or Minor Stroke (WP5) | 12 months | Discrimination (C-statistic, with 95% CI) of the AI risk model for predicting recurrent stroke, benchmarked against the ABCD2 score. | ClinicalTrials.gov |
| Primary | AUC of the Multimodal AI Tool for Identification of a Cardio-aortic Source of Embolism (WP6) | 7 to 30 days after stroke onset | Discriminative performance (area under the receiver operating characteristic curve, with 95% CI) of the multimodal AI tool combining cardiac CT, ECG and blood biomarkers for identifying a cardio-aortic source of embolism, using the final etiological diagnosis as the reference standard. | ClinicalTrials.gov |
| Secondary | AUC of the Pre-hospital AI Model for Detection of Intracerebral Hemorrhage (WP2) | At hospital admission (Day 1) | Discriminative performance (area under the receiver operating characteristic curve, with 95% CI) of the pre-hospital AI model for identifying intracerebral hemorrhage, using the final in-hospital diagnosis as the reference standard. | ClinicalTrials.gov |
| Secondary | AUC of the Pre-hospital AI Model for Differentiating Stroke From Stroke Mimic (WP2) | At hospital admission (Day 1) | Discriminative performance (area under the receiver operating characteristic curve, with 95% CI) of the pre-hospital AI model for differentiating stroke from stroke mimic, using the final in-hospital diagnosis as the reference standard. | ClinicalTrials.gov |
| Secondary | Accuracy of the Image-based AI Tool for Prediction of the Arterial Access Route (WP3) | Day 1 (at the end of the endovascular procedure) | Percentage of endovascular procedures in which the arterial access route predicted by the AI tool (e.g., femoral or radial) matches the access route actually used. | ClinicalTrials.gov |
| Secondary | Accuracy of the Image-based AI Tool for Prediction of the First-line Thrombectomy Technique (WP3) | Day 1 (at the end of the endovascular procedure) | Percentage of endovascular procedures in which the first-line thrombectomy technique predicted by the AI tool (e.g., stent retriever, aspiration or combined) matches the technique actually used. | ClinicalTrials.gov |
| Secondary | AUC of the AI Model for Prediction of Early Neurological Deterioration in Intracerebral Hemorrhage (WP4) | 24 hours after admission | Discriminative performance (area under the receiver operating characteristic curve, with 95% CI) of the AI model for predicting early neurological deterioration, assessed with the National Institutes of Health Stroke Scale (NIHSS). | ClinicalTrials.gov |
| Secondary | AUC of the AI Model for Prediction of Poor Functional Outcome After Intracerebral Hemorrhage (WP4) | 70 to 90 days after stroke onset | Discriminative performance (area under the receiver operating characteristic curve, with 95% CI) of the AI model for predicting poor functional outcome, defined as a modified Rankin Scale (mRS) score of 3 to 6. | ClinicalTrials.gov |
| Secondary | AUC of the Multimodal AI Tool for Prediction of Newly Diagnosed Atrial Fibrillation (WP6) | 12 months | Discriminative performance (area under the receiver operating characteristic curve, with 95% CI) of the multimodal AI tool combining cardiac CT, ECG and blood biomarkers for predicting atrial fibrillation newly diagnosed during follow-up. | ClinicalTrials.gov |
| Secondary | Percentage of Participants With Recurrent Stroke | 12 months | Any new ischemic or hemorrhagic stroke occurring after the index event. | ClinicalTrials.gov |
| Secondary | Percentage of Participants With Major Adverse Cardiovascular Events (MACE) | 12 months | Composite of recurrent stroke, myocardial infarction and cardiovascular death. | ClinicalTrials.gov |
| Secondary | Percentage of Participants With Hospital Re-admission | 12 months | Any unplanned hospital re-admission after discharge from the index hospitalization. | ClinicalTrials.gov |
| Secondary | All-cause Mortality | 12 months | Percentage of participants who died from any cause. | ClinicalTrials.gov |
| Secondary | Functional Outcome Measured With the Modified Rankin Scale (mRS) | 70 to 90 days after stroke onset | The mRS ranges from 0 (no symptoms) to 6 (death); higher scores indicate worse functional outcome. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)