Clinical trial NCT05299034: Optimizing the Radiological Selection and Transfer Model in Stroke Patients Presenting 6-24h After Onset (VESTA Study)
Official title: Treatment of Stroke in the Extended Window: Optimization of the Radiological Selection and Transfer Model in Patients With a Stroke Presenting 6-24h After Symptoms Onset (VESTA Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke, Ischemic
Lead sponsor: Germans Trias i Pujol Hospital
Sponsor class: OTHER
Collaborators: name: Carlos III Health Institute
First posted: 2022-03-28
Enrollment: 2173
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients with stroke suspiction in Catalonia included in the CICAT registry

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.


Eligibility 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.

Primary outcomes:
measure: mRS at 90 days
timeFrame: 90 days after stroke
measure: Rate of patients treated with mechanical thrombectomy
timeFrame: less than 24 hours after the diagnostic test
Secondary outcomes:
measure: Mortality at discharge and at day 90
timeFrame: 90 days after stroke
measure: Symptomatic intracerebral hemorrhage, defined as PH2 or SAH on imaging test at 24-72 hours associated with a worsening in NIHSS ≥ 4 points
timeFrame: From 24 to 72 hours after stroke
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Germans Trias i Pujol Hospital
state: Barcelona
Study officials:
References: