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

Organizational Data

DRKS-ID:
DRKS00024407
Recruitment Status:
Recruiting planned
Date of registration in DRKS:
2022-03-31
Last update in DRKS:
2023-01-27
Registration type:
Prospective

Acronym/abbreviation of the study

PREDICT-Juvenile-Stroke

URL of the study

No Entry

Brief summary in lay language

The prognosis of stroke occurring in persons younger than 55 years, differs from that in older patients with stroke. Also, due to their young age and long life-expectancy other considerations like future pregnancy or unemployment have to be taken into account when counseling young patients with stroke. In order to improve counseling, we aim to evaluate a new prediction method for the three months outcome after young adult stroke at 4 participating study centers throughout Germany. The prediction method uses clinical, imaging and laboratory data to determine the individual clinical outcome three months after stroke. In order to evaluate the method these data will be collected from acute stroke patients aged over 18 years as part of clinical routine. Treatment follows best clinical practice. The clinical outcome will be assessed at a routine examination three months after stroke or by a structured telephone interview.

Brief summary in scientific language

Due to the young age and long-life expectancy in juvenile stroke, the prognosis and therefore counselling of patients differs from that in older patients with stroke. The long-term medical, psychosocial and socioeconomic consequences are particularly severe in this young age group. Therefore, the identification of new risk factors and the development of a reliable prediction score for the outcome after juvenile stroke or TIA (transient ischemic attack) are needed to enable personalisation of counselling and identifying patients who benefit from a specific treatment. PREDICT-Juvenile-Stroke is a multi-centre, prospective observational cohort study in stroke/TIA (transient ischemic attack) patients that aims to validate a juvenile stroke outcome prediction score, that is derived from an independent retrospective cohort study, using a combined set of clinical and paraclinical data. The score will determine the patient’s probability for treatment success defined by a modified Rankin Scale (mRS) 0-2 or return to baseline of function three months after stroke. The study population consists of acute stroke/TIA patients. All information is collected as part of clinical routine and treatment follows best clinical practice. Clinical success will be assessed within the framework of a routine examination three months after stroke/TIA or alternatively by a structured telephone interview. The analysis will be performed in a distributed manner. To analyse the primary endpoint (i.e. mRS 0-2 at 3 months) we will validate the discriminatory power of the prediction score by evaluating the AUC of the ROC. The current study is the first that aims to prospectively validate the clinical potential of a prediction score for the three months functional outcome after juvenile stroke. Furthermore, the study cohort of juvenile and older stroke patients will facilitate further research of stroke sequelae and factors predicting them with a particular attention to age.

Health condition or problem studied

ICD10:
I63 - Cerebral infarction
ICD10:
I64 - Stroke, not specified as haemorrhage or infarction
ICD10:
G45 - Transient cerebral ischaemic attacks and related syndromes
Healthy volunteers:
No Entry

Interventions, Observational Groups

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

Endpoints

Primary outcome:
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 outcome:
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.

Study Design

Purpose:
Prognosis
Retrospective/prospective:
No Entry
Study type:
Non-interventional
Longitudinal/cross-sectional:
No Entry
Study type non-interventional:
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Recruitment

Recruitment Status:
Recruiting planned
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Multicenter study
Recruitment location(s):
  • University medical center Neurologische Klinik und Poliklinik, Klinikum rechts der Isar, Technische Universität München, Klinikum rechts der Isar München
  • University medical center Klinik für Neurologie, Universitätsklinikum Ulm
  • University medical center Neurologische Klinik und Poliklinik, LMU Klinikum München
  • University medical center Neurologische Universitätsklinik, Abt. mit Schwerpunkt Neurovaskuläre Erkrankungen,Universitätsklinikum Tübingen

Recruitment period and number of participants

Planned study start date:
2023-06-01
Actual study start date:
No Entry
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
430
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional 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

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.

Addresses

Primary Sponsor

Neurologische Klinik und Poliklinik, LMU Klinikum, LMU München
Prof. Dr. Lars Kellert
Marchioninistr. 15
81377 München
Germany
Telephone:
+49-89-4400-73692
Fax:
+49-89-4400-73677
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Neurologische Klinik und Poliklinik, LMU Klinikum, LMU München
Prof. Dr. Lars Kellert
Marchioninistr. 15
81377 München
Germany
Telephone:
+49-89-4400-73692
Fax:
+49-89-4400-73677
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Neurologische Klinik und Poliklinik, LMU Klinikum, LMU München
Prof. Dr. Lars Kellert
Marchioninistr. 15
81377 München
Germany
Telephone:
+49-89-4400-73692
Fax:
+49-89-4400-73677
Contact per E-Mail
URL:
No Entry

Principal Investigator

Neurologische Klinik und Poliklinik, LMU Klinikum, LMU München
Prof. Dr. Lars Kellert
Marchioninistr. 15
81377 München
Germany
Telephone:
+49-89-4400-73692
Fax:
+49-89-4400-73677
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)

Neurologische Klinik und Poliklinik, LMU Klinikum, LMU München
Marchioninistr. 15
81377 München
Germany
Telephone:
+49-89-4400-73692
Fax:
+49-89-4400-73677
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethikkommission der Med. Fakultät der LMU
Pettenkoferstraße 8
80336 München
Germany
Telephone:
+49-89-440055191
Fax:
+49-89-440055192
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2021-02-04
Ethics committee number:
21-0136
Vote of the Ethics Committee:
Approved
Date of the vote:
2022-03-09

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
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Study abstract:
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Other study documents:
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Background literature:
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Related DRKS studies:
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Publication of study results

Planned publication:
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Publikationen/Studienergebnisse:
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Date of first publication of study results:
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DRKS entry published for the first time with results:
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Basic reporting

Basic Reporting / Results tables:
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Brief summary of results:
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