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NCT Number: NCT05299034

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

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.

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Key information

Conditions

Stroke, Ischemic Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Germans Trias i Pujol Hospital

Badalona, Barcelona, 08916, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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
  • Age older than 18 years,
  • Diagnosis of acute cerebral infarction,
  • More than six hours of evolution or uncertain chronology of symptoms,
  • Absence of disability prior to stroke (modified Rankin score 0-2),
  • NIHSS score>5,
  • 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:
  • Age over 18 years,
  • Suspicion of acute cerebral infarction,
  • More than six hours of evolution or uncertain chronology of symptoms,
  • absence of pre-stroke disability (modified Rankin score 0-2),
  • NIHSS score greater than 5.

Treatment and study plan

Multiparametric imaging

Diagnostic Test

MR perfusion or multiparametric CT including NCCT, CTA and CTP

Non contrast CT+CT angiography

Diagnostic Test

NCCT+CTA

Primary outcomes

  1. mRS at 90 days

    Time frame: 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.

  2. Rate of patients treated with mechanical thrombectomy

    Time frame: less than 24 hours after the diagnostic test

Secondary outcomes

  1. Mortality at discharge and at day 90

    Time frame: 90 days after stroke

  2. Symptomatic intracerebral hemorrhage, defined as PH2 or SAH on imaging test at 24-72 hours associated with a worsening in NIHSS ≥ 4 points

    Time frame: From 24 to 72 hours after stroke

Sponsors and collaborators

Lead sponsor

Germans Trias i Pujol Hospital

Other

Collaborators

  • Carlos III Health Institute

Registry information

Official study 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)

Acronym: VESTA

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 28, 2022
Registry last updated
Aug 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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