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Published on: February 22, 2020
PREDICT-juvenile-stroke: PRospective evaluation of a prediction score determining individual clinical outcome three
Sonja Schönecker1, Verena Hoffmann2, Fady Albashiti3
1Department of Neurology, Ludwig-Maximilians-Universität München, Marchioninistr. 15, D-81377, Munich, Germany.
Insights
A new prediction score for juvenile stroke aims to improve prognosis prediction. This study will validate its ability to forecast functional outcomes in young stroke patients.
Area of Science:
- Neurology
- Clinical Prediction Models
- Public Health
Background:
- A reliable prediction model for juvenile stroke prognosis (ages 18-55) is currently lacking.
- Juvenile stroke has significant individual and socioeconomic impact.
- This study addresses the need for validated prognostic tools in this demographic.
Purpose of the Study:
- To prospectively validate a prediction score for 3-month functional outcomes in juvenile stroke and transient ischemic attack (TIA).
- To assess the score's discriminatory power using standard clinical data.
- To compare the score's predictive accuracy against observed outcomes.
Main Methods:
- A multi-center, prospective observational cohort study (PREDICT-Juvenile-Stroke).
- Enrollment of at least 430 juvenile patients (<55 years) and 430 older patients with acute ischemic stroke or TIA.
- Validation of a score derived from retrospective analysis, comparing predicted vs. observed outcomes (modified Rankin Scale) at 3 months.
Main Results:
- The primary endpoint is the validation of the prediction score's clinical utility for favorable outcomes.
- Secondary outcomes include comparing predictive factors between juvenile and older stroke patients.
- Further analysis will assess the score's accuracy on various clinical and paraclinical endpoints.
Conclusions:
- The validated juvenile stroke prediction score can personalize patient counseling and information delivery.
- It aids in identifying patients who may benefit from specific treatment strategies.
- This tool has the potential to improve care and outcomes for young stroke survivors.
Background:
Although of high individual and socioeconomic relevance, a reliable prediction model for the prognosis of juvenile stroke (18-55 years) is missing. Therefore, the study presented in this protocol aims to prospectively validate the discriminatory power of a prediction score for the 3 months functional outcome after juvenile stroke or transient ischemic attack (TIA) that has been derived from an independent retrospective study using standard clinical workup data.
Methods:
PREDICT-Juvenile-Stroke is a multi-centre (n = 4) prospective observational cohort study collecting standard clinical workup data and data on treatment success at 3 months after acute ischemic stroke or TIA that aims to validate a new prediction score for juvenile stroke. The prediction score has been developed upon single center retrospective analysis of 340 juvenile stroke patients. The score determines the patient's individual probability for treatment success defined by a modified Rankin Scale (mRS) 0-2 or return to pre-stroke baseline mRS 3 months after stroke or TIA. This probability will be compared to the observed clinical outcome at 3 months using the area under the receiver operating characteristic curve. The primary endpoint is to validate the clinical potential of the new prediction score for a favourable outcome 3 months after juvenile stroke or TIA. Secondary outcomes are to determine to what extent predictive factors in juvenile stroke or TIA patients differ from those in older patients and to determine the predictive accuracy of the juvenile stroke prediction score on other clinical and paraclinical endpoints. A minimum of 430 juvenile patients (< 55 years) with acute ischemic stroke or TIA, and the same number of older patients will be enrolled for the prospective validation study.
Discussion:
The juvenile stroke prediction score has the potential to enable personalisation of counselling, provision of appropriate information regarding the prognosis and identification of patients who benefit from specific treatments.
Trial Registration:
The study has been registered at https://drks.de on March 31, 2022 ( DRKS00024407 ).
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