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

NCT05299034 | Completed

• 1 other identifier: PI21/01548
• Study Type: observational
• Target: 2,173
• Locations: 1 country
• Sites: 1

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. 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. 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. 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.
4. 4.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.
5. 5.validation of the models in a prospective study. Clinical, radiological and transport variables will be studied.

Conditions

Stroke, Ischemic

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (2)

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

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

Interventions

Multiparametric imaging DIAGNOSTIC_TEST

MR perfusion or multiparametric CT including NCCT, CTA and CTP

Stroke patients 6-24h receiving multimodal imaging

Non contrast CT+CT angiography DIAGNOSTIC_TEST

NCCT+CTA

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Germans Trias i Pujol Hospital: lead
• Carlos III Health Institute: collaborator

Study Sites (1)

Germans Trias i Pujol Hospital

Badalona, Barcelona, 08916, Spain

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Multiparametric Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Magnetic Resonance Imaging; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: March 28, 2022
• Study Start: January 14, 2022
• Primary Completion: August 15, 2023
• Study Completion: August 15, 2023
• Last Updated: August 22, 2023

Record last verified: 2023-08

Locations

ES (1)