Clinical trial NCT04092543: Validation of DRAGON Versus a Simplified DRAGON/Machine Learning
Official title: Prediction of Outcome After Acute Stroke: Validation of CT-DRAGON Versus a Simplified CT-DRAGON Score
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke, Acute
Keywords: CT-DRAGON score
Lead sponsor: Ziekenhuis Oost-Limburg
Sponsor class: OTHER
Collaborators: name: University Hospital, Ghent
First posted: 2019-09-17
Enrollment: 700
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients diagnosed with a stroke will be analyzed in the database starting from March 1, 2019 until August 1 2021

Brief summary: The CT-DRAGON score can predict long-term functional outcome after acute stroke treated by thrombolysis. However, implementation in clinical practice is hampered by a lack of validation in the broad spectrum of stroke patients undergoing thrombectomy, whether or not in combination with thrombolysis or conservative treatment. Furthermore, the CT-DRAGON score considers multiple items, which are not always readily available in every setting. This study aims to investigate whether either a simplified version of the CT-DRAGON score with only three clinical items or a machine learning technique could be as powerful and more feasible.

Detailed description: The investigators aim to validate the CT-DRAGON score in all ischaemic stroke localisations and for all treatment options, including a conservative treatment policy. The predictability will then be compared with on the one hand simplified prognostic models that include only a selective set of highly predictive parameters that have already been described in the literature, such as patient age, National Institutes of Health Stroke Scale (NIHSS) and pre-stroke modified Rankin Scale (mRS). On the other hand, machine learning techniques, that incorporate a large set of variables and have recently shown some promising results, will also be applied to predict long-term outcome after ischaemic stroke.

Eligibility criteria: Inclusion Criteria:

* all patients diagnosed with a stroke

Exclusion Criteria:

-

Primary outcomes:
measure: Modified Rankin Scale at day 90
timeFrame: 90 days after the onset of stroke
measure: Modified Rankin Scale at 7 days after discharge
timeFrame: 7 days after discharge at the hospital
Secondary outcomes:
measure: PROMIS 10 questionnaire at 7 days after discharge
timeFrame: 7 days after discharge
measure: PROMIS 10 questionnaire at 90 days after the onset of stroke
timeFrame: 90 days after the onset of stroke
measure: NIHSS at 90 days after the onset of stroke
timeFrame: 90 days after the onset of stroke
measure: Analysis of the hospitalization cost after the onset of stroke
timeFrame: 90 days after the onset of stroke
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
Study officials:
affiliation: Ziekenhuis Oost-Limburg
name: dieter Mesotten, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lesenne A, Grieten J, Ernon L, Wibail A, Stockx L, Wouters PF, Dreesen L, Vandermeulen E, Van Boxstael S, Vanelderen P, Van Poucke S, Vundelinckx J, Van Cauter S, Mesotten D. Prediction of Functional Outcome After Acute Ischemic Stroke: Comparison of the CT-DRAGON Score and a Reduced Features Set. Front Neurol. 2020 Jul 31;11:718. doi: 10.3389/fneur.2020.00718. eCollection 2020.