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

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)

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.

Study Overview

• Status: Completed
• Conditions: Stroke, Ischemic
• Intervention / Treatment: Diagnostic test: Multiparametric imaging; Diagnostic test: Non contrast CT+CT angiography

• Study Type: Observational
• Enrollment (Actual): 2173

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Germans Trias i Pujol Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients with stroke suspiction in Catalonia included in the CICAT registry

Description

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Stroke patients 6-24h receiving non-contrast CT + CTA; Stroke patients 6-24h undergoing non-contrast CT + CTA to decide stroke therapy	Diagnostic test: Non contrast CT+CT angiography; NCCT+CTA
Stroke patients 6-24h receiving multimodal imaging; Stroke patients 6-24h undergoing NCCT+CTA+CTP or MRI with DWI and PWI imaging to decide stroke therapy	Diagnostic test: Multiparametric imaging; MR perfusion or multiparametric CT including NCCT, CTA and CTP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mRS at 90 days	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.	90 days after stroke
Rate of patients treated with mechanical thrombectomy		less than 24 hours after the diagnostic test

Secondary Outcome Measures

Outcome Measure	Time Frame
Mortality at discharge and at day 90	90 days after stroke
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

Collaborators and Investigators

• Sponsor: Germans Trias i Pujol Hospital
• Collaborators: Carlos III Health Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2022
• Primary Completion (Actual): August 15, 2023
• Study Completion (Actual): August 15, 2023

Study Registration Dates

• First Submitted: January 13, 2022
• First Submitted That Met QC Criteria: March 17, 2022
• First Posted (Actual): March 28, 2022

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 18, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: PI21/01548

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No