Optimizing the Radiological Selection and Transfer Model in Stroke Patients Presenting 6-24h After Onset (VESTA Study)

Completed

• Conditions: Stroke, Ischemic
• Interventions: Diagnostic Test: Multiparametric imaging; Diagnostic Test: Non contrast CT+CT angiography

• Registration Number: NCT05299034
• Lead Sponsor: Germans Trias i Pujol Hospital

Brief Summary

We aim to optimize the radiological selection and the transfer model in patients with a 6-24h stroke for a fairer and broader access to a reperfusion treatment. The specific objectives are:

1. To confirm that the selection of patients for reperfusion therapies in the late window is safe by applying the same clinical and imaging criteria recommended by clinical guidelines for the early window treatment selection.

2. To evaluate the performance of non-contrast CT by applying immediate post-processing software for the selection of patients for reperfusion treatment in the late window.

3. To analyze the prehospital and arrival variables at the primary stroke center to generate decision trees that optimize the transfer decision in patients with activation of the stroke code in \>6h from the onset of symptoms.

METHODOLOGY: Study based on a mandatory, prospective, multicenter registry (CICAT registry) consisting of two phases

1. retrospective analysis with a detailed evaluation of the images of the included patients and generation of "machine learning" models that accurately predict the probability of receiving reperfusion treatment in the late window.

2. validation of the models in a prospective study. Clinical, radiological and transport variables will be studied.

Response variables: rate of patients receiving reperfusion treatment in the late window, functional prognosis at 90 days, hemorrhagic transformation, and mortality.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-13
• Study Start: 2022-01-14
• Study First Submitted QC: 2022-03-17
• Study First Posted: 2022-03-28
• Status Verified: 2023-08
• Primary Completion: 2023-08-15
• Study Completion: 2023-08-15
• Last Update Submitted: 2023-08-18
• Last Update Posted: 2023-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2173

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stroke patients 6-24h receiving multimodal imaging	Multiparametric imaging	Stroke patients 6-24h undergoing NCCT+CTA+CTP or MRI with DWI and PWI imaging to decide stroke therapy
Stroke patients 6-24h receiving non-contrast CT + CTA	Non contrast CT+CT angiography	Stroke patients 6-24h undergoing non-contrast CT + CTA to decide stroke therapy

Primary Outcome Measures

Name	Time	Method
mRS at 90 days	90 days after stroke	Percentage of patients with functional independence, defined as mRS \< or =2 on day 90 as assessed centrally by blinded evaluators of the Catalan Stroke Master Plan.
Rate of patients treated with mechanical thrombectomy	less than 24 hours after the diagnostic test

Secondary Outcome Measures

Name	Time	Method
Symptomatic intracerebral hemorrhage, defined as PH2 or SAH on imaging test at 24-72 hours associated with a worsening in NIHSS ≥ 4 points	From 24 to 72 hours after stroke
Mortality at discharge and at day 90	90 days after stroke

Trial Locations

Locations (1)

Germans Trias i Pujol Hospital; 🇪🇸 Badalona, Barcelona, Spain