PRospective Evaluation of a prediction score Determining Individual Clinical outcome Three months after Juvenile Stroke

PRospective Evaluation of a prediction score Determining Individual Clinical outcome Three months after Juvenile Stroke - PREDICT-Juvenile-Stroke

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00024407

Enrollment

430

Registered

2022-03-31

Start date

2027-06-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I63 I64 G45

Interventions

Group 1: Controls: Patients with a favorable outcome defined as mRS 0-2 or return to baseline of function. Group 2: Cases: Patients with a favorable outcome defined as mRS greater than 2.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: I 01. Male and female juvenile stroke patients aged 18 to 55 years and older stroke patients >55 years I 02. Written informed consent by the patient, if capable, or their legal representatives, if available, obtained at the latest prior to the three months follow-up visit.

Exclusion criteria

Exclusion criteria: E 01. The patient is directly involved in the conduct of the protocol: the investigator or subinvestigator, research assistant, pharmacist, study coordinator, other staff or relatives thereof. E 02. Refusal of consent, in patients/legal representatives capable of giving informed consent.

Design outcomes

Primary

Measure	Time frame
To validate a prediction score for a good outcome (mRS 0-2 or back to baseline) three months after juvenile stroke by assessing its discrimination using the AUC of the ROC (H0: AUC < 0.7)	—

Secondary

Measure	Time frame
Clinical secondary endpoints: * Recurrent ischemic or haemorrhagic stroke/TIA three months after index stroke * Other vascular events (myocardial infarction, vascular death) * Quality of life (EQ5D5L) * Depression (BDI) * Cognitive assessment (MoCA) Paraclinical secondary endpoints: * Laboratory parameters (e.g. cholesterol, triglycerides) * CT/MRI (recurrent ischemic or haemorrhagic stroke on imaging) * Doppler/duplex sonography (extent of macroangiopathy, Intima-media thickness, IMT) Outcomes: * Determining to what extent predictive factors in juvenile stroke/TIA patients differ from those in older patients with stroke/TIA * Cut-off values for treatment decision making together with related sensitivity, specificity and predictive values * Correlation of the juvenile stroke prediction score with changes in clinical scores (NIHSS, mRS) * Correlation of the juvenile stroke prediction score with quality of life (EQ5D5L), depression (BDI) and cognitive function (MoCA) * Correlation of biomarker data with clinical or paraclinical outcome parameters * Predictive accuracy of the juvenile stroke prediction score on other secondary clinical and paraclinical endpoints * Calibration of the juvenile stroke prediction score, Brier Score, and “concordance statistic for benefit” * Quantifying the amount of overfitting which occurred in the analysis of the retrospective patient cohort by comparing ROCs and AUCs between the retro- and prospective patient cohorts.	—

Measure

Time frame

Clinical secondary endpoints: * Recurrent ischemic or haemorrhagic stroke/TIA three months after index stroke * Other vascular events (myocardial infarction, vascular death) * Quality of life (EQ5D5L) * Depression (BDI) * Cognitive assessment (MoCA) Paraclinical secondary endpoints: * Laboratory parameters (e.g. cholesterol, triglycerides) * CT/MRI (recurrent ischemic or haemorrhagic stroke on imaging) * Doppler/duplex sonography (extent of macroangiopathy, Intima-media thickness, IMT) Outcomes: * Determining to what extent predictive factors in juvenile stroke/TIA patients differ from those in older patients with stroke/TIA * Cut-off values for treatment decision making together with related sensitivity, specificity and predictive values * Correlation of the juvenile stroke prediction score with changes in clinical scores (NIHSS, mRS) * Correlation of the juvenile stroke prediction score with quality of life (EQ5D5L), depression (BDI) and cognitive function (MoCA) * Correlation of biomarker data with clinical or paraclinical outcome parameters * Predictive accuracy of the juvenile stroke prediction score on other secondary clinical and paraclinical endpoints * Calibration of the juvenile stroke prediction score, Brier Score, and “concordance statistic for benefit” * Quantifying the amount of overfitting which occurred in the analysis of the retrospective patient cohort by comparing ROCs and AUCs between the retro- and prospective patient cohorts.

—

Countries

Germany

Contacts

Public ContactLars Kellert

Neurologische Klinik und Poliklinik, LMU Klinikum, LMU München

lars.kellert@med.uni-muenchen.de+49-89-4400-73692

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 9, 2026