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Optimization of the Radiological Selection and Transfer Model in Patients With a Stroke Presenting 6-24h After Symptoms Onset (VESTA Study)

Sponsor
Germans Trias i Pujol Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05299034
Collaborator
Carlos III Health Institute (Other)
2,500
Enrollment
1
Location
35.5
Anticipated Duration (Months)
70.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Multiparametric imaging
  • Diagnostic Test: Non contrast CT+/- CT angiography

Study Design

Study Type:
Observational
Anticipated Enrollment :
2500 participants
Observational Model:
Cohort
Time Perspective:
Other
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)
Actual Study Start Date :
Jan 14, 2022
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Extended window EVT patients selected by multiparametric imaging

Diagnostic Test: Multiparametric imaging
MR perfusion or multiparametric CT including NCCT, CTA and CTP
Extended window EVT patients selected by non-contrast CT

Diagnostic Test: Non contrast CT+/- CT angiography
Non contrast CT or NCCT+CTA
Untreated stroke patients 6-24h fullfiling conventional non-contrast CT criteria for EVT

Diagnostic Test: Multiparametric imaging
MR perfusion or multiparametric CT including NCCT, CTA and CTP

Diagnostic Test: Non contrast CT+/- CT angiography
Non contrast CT or NCCT+CTA

Outcome Measures

Primary Outcome Measures

  1. mRS at 90 days [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 [less than 24 hours after the diagnostic test]

Secondary Outcome Measures

  1. Mortality at discharge and at day 90 [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 [From 24 to 72 hours after stroke]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Germans Trias i Pujol Hospital Badalona Barcelona Spain 08916

Sponsors and Collaborators

  • Germans Trias i Pujol Hospital
  • Carlos III Health Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
María Hernández Pérez, MD, PhD, Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier:
NCT05299034
Other Study ID Numbers:
  • PI21/01548
First Posted:
Mar 28, 2022
Last Update Posted:
Mar 28, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Stroke
Ischemic Stroke

Study Results

No Results Posted as of Mar 28, 2022