Very-Low-Field MRI for the Diagnosis of Acute Stroke
NCT07930013, Not applicable, Not yet recruiting, Centre Hospitalier St Anne
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Very-Low-Field MRI for the Diagnosis of Acute Stroke | ClinicalTrials.gov |
| NCT number | NCT07930013 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 230 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Centre Hospitalier St Anne | ClinicalTrials.gov |
| Conditions | Stroke | ClinicalTrials.gov |
| Interventions | Very-low-field MRI | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Sensitivity of AI-enhanced very-low-field MRI for the diagnosis of acute ischemic stroke | At inclusion (very-low-field MRI performed within 4 hours after 3T MRI) | Sensitivity (%) of AI-enhanced very-low-field MRI (0.064 T) for detecting acute ischemic stroke in patients with suspected hyperacute stroke (Part 3), using high-field 3T MRI as the reference standard. Images are read independently by two neuroradiologists blinded to 3T MRI results, with consensus in case of disagreement. Non-interpretable very-low-field MRI scans are classified as negative for stroke. | ClinicalTrials.gov |
| Primary | Specificity of AI-enhanced very-low-field MRI for the diagnosis of acute ischemic stroke | At inclusion (very-low-field MRI performed within 4 hours after 3T MRI) | Specificity (%) of AI-enhanced very-low-field MRI (0.064 T) for excluding acute ischemic stroke in patients with suspected hyperacute stroke (Part 3), using high-field 3T MRI as the reference standard. Images are read independently by two neuroradiologists blinded to 3T MRI results, with consensus in case of disagreement. Non-interpretable very-low-field MRI scans are classified as negative for stroke. | ClinicalTrials.gov |
| Secondary | Sensitivity and specificity of very-low-field MRI without AI enhancement for acute ischemic stroke | At inclusion (very-low-field MRI performed within 4 hours after 3T MRI) | Sensitivity and specificity (%) of non-enhanced very-low-field MRI for acute ischemic stroke, compared with AI-enhanced very-low-field MRI (McNemar test), using 3T MRI as reference. | ClinicalTrials.gov |
| Secondary | Diagnostic accuracy of very-low-field MRI for intracranial hemorrhage | At inclusion (very-low-field MRI performed within 4 hours after 3T MRI) | Sensitivity and specificity (%) of very-low-field MRI (with and without AI enhancement) for detecting intracranial hemorrhage, using 3T MRI as reference. | ClinicalTrials.gov |
| Secondary | Diagnostic accuracy of very-low-field MR angiography for proximal arterial occlusion | At inclusion (very-low-field MRI performed within 4 hours after 3T MRI) | Sensitivity and specificity (%) of very-low-field MR angiography for detecting proximal intracranial arterial occlusion, using 3T 3D time-of-flight MR angiography as reference | ClinicalTrials.gov |
| Secondary | Diagnostic accuracy of very-low-field MRI for stroke mimics | At inclusion (very-low-field MRI performed within 4 hours after 3T MRI) | Proportion (%) of stroke mimics correctly identified on very-low-field MRI, using the final diagnosis based on 3T MRI as reference. | ClinicalTrials.gov |
| Secondary | Agreement in ischemic lesion volume between very-low-field and 3T MRI | At inclusion (very-low-field MRI performed within 4 hours after 3T MRI) | Ischemic lesion volume (mL) measured on very-low-field and 3T diffusion-weighted images, compared with Pearson correlation and Bland-Altman analysis | ClinicalTrials.gov |
| Secondary | Diagnostic accuracy of very-low-field MRI for hemorrhagic transformation | 24 ± 12 hours after inclusion (patients with follow-up very-low-field MRI) | Detection of hemorrhagic transformation (ECASS II classification) on follow-up very-low-field MRI. | ClinicalTrials.gov |
| Secondary | Intra- and inter-reader agreement | At inclusion (very-low-field MRI performed within 4 hours after 3T MRI) | Cohen's kappa coefficients for intra- and inter-reader agreement on the diagnosis of ischemic stroke on very-low-field MRI | ClinicalTrials.gov |
| Secondary | Agreement on simulated therapeutic decisions | At inclusion (very-low-field MRI performed within 4 hours after 3T MRI) | Agreement (kappa) between simulated treatment decisions made by four reader pairs based on very-low-field MRI and decisions based on 3T MRI | ClinicalTrials.gov |
| Secondary | Image quality metrics of AI-enhanced very-low-field MRI | At inclusion (very-low-field MRI performed within 4 hours after 3T MRI) | Peak signal-to-noise ratio (PSNR) and structural similarity index (SSIM) of AI-enhanced very-low-field images compared with 3T images. | 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)