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

Germans Trias i Pujol Hospital

Status: Completed

Conditions: Stroke, Ischemic

Treatments: Diagnostic Test: Non contrast CT+CT angiography; Diagnostic Test: Multiparametric imaging

Study type: Observational

Funder types: Other

Identifiers

NCT05299034

PI21/01548

Details and patient eligibility

About

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.

Enrollment: 2,173 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• SUBSTUDY 1. OPTIMIZATION OF IMAGING SELECTION METHODS FOR SELECTING STROKE PATIENTS FOR REPERFUSION TREATMENT IN THE EXTENDED WINDOW.

  • Inclusion criteria: Consecutive patients registered in the CICAT registry between the years 2019 and 2021 with a stroke who meet the following criteria
  1. Age older than 18 years,
  2. Diagnosis of acute cerebral infarction,
  3. More than six hours of evolution or uncertain chronology of symptoms,
  4. Absence of disability prior to stroke (modified Rankin score 0-2),
  5. NIHSS score>5,
  6. Neuroimaging study including at least one non-contrast cranial CT scan within 60 minutes of arrival at the hospital center.

• SUBSTUDY 2. OPTIMIZATION OF CIRCUITS AND TRANSFER MODEL IN PATIENTS WITH STROKE IN THE EXTENDED WINDOW OF TREATMENT.

  • Inclusion criteria: Selection of consecutive, prospective patients to be included in the CICAT registry between January 2023 and March 2024 with stroke meeting the following criteria:

    1. Age over 18 years,
    2. Suspicion of acute cerebral infarction,
    3. More than six hours of evolution or uncertain chronology of symptoms,
    4. absence of pre-stroke disability (modified Rankin score 0-2),
    5. NIHSS score greater than 5.

Trial design

2,173 participants in 2 patient groups

Stroke patients 6-24h receiving non-contrast CT + CTA

Description:

Stroke patients 6-24h undergoing non-contrast CT + CTA to decide stroke therapy

Treatment:

Diagnostic Test: Non contrast CT+CT angiography

Stroke patients 6-24h receiving multimodal imaging

Description:

Stroke patients 6-24h undergoing NCCT+CTA+CTP or MRI with DWI and PWI imaging to decide stroke therapy

Treatment:

Diagnostic Test: Multiparametric imaging