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Validation of DRAGON Versus a Simplified DRAGON/Machine Learning

Prediction of Outcome After Acute Stroke: Validation of CT-DRAGON Versus a Simplified CT-DRAGON Score

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04092543
Enrollment
700
Registered
2019-09-17
Start date
2019-03-01
Completion date
2021-11-01
Last updated
2019-09-17

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

Conditions

Stroke, Acute

Keywords

CT-DRAGON score

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.

Interventions

None listed

Sponsors

University Hospital, Ghent
CollaboratorOTHER
Ziekenhuis Oost-Limburg
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* all patients diagnosed with a stroke

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Modified Rankin Scale at day 9090 days after the onset of strokeThe modified rankin scale will be assessed at 90 days at a consultation or by a telephonic interview which is standard of care in the hospital. The scale runs from 0-6, running from perfect health without symptoms to death.
Modified Rankin Scale at 7 days after discharge7 days after discharge at the hospitalThe modified rankin scale will be assessed at 7 days after discharge by a telephonic interview which is standard of care in the hospital. he scale runs from 0-6, running from perfect health without symptoms to death.

Secondary

MeasureTime frameDescription
PROMIS 10 questionnaire at 7 days after discharge7 days after dischargeThe Patient-Reported Outcomes Measurement Information System (PROMIS) is a publically available global health assessment tool that allows measurements of symptoms, functioning, and healthcare-related quality of life.The scoring system of the PROMIS Global-10 allows each of the individual items to be examined separately to provide specific information about perceptions of physical function, pain, fatigue, emotional distress, social health and general perceptions of health.The summed total is reported as 0 to 48 with higher scores reflecting less pain and better function.
PROMIS 10 questionnaire at 90 days after the onset of stroke90 days after the onset of strokeThe Patient-Reported Outcomes Measurement Information System (PROMIS) is a publically available global health assessment tool that allows measurements of symptoms, functioning, and healthcare-related quality of life.The scoring system of the PROMIS Global-10 allows each of the individual items to be examined separately to provide specific information about perceptions of physical function, pain, fatigue, emotional distress, social health and general perceptions of health. The summed total is reported as 0 to 48 with higher scores reflecting less pain and better function.
NIHSS at 90 days after the onset of stroke90 days after the onset of strokeChange in NIHSS over time: baseline (diagnosis stroke), 3 months and one year follow-up. The National Institutes of Health Stroke Scale (NIHSS) is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.
Analysis of the hospitalization cost after the onset of stroke90 days after the onset of stroke90 days after the onset of stroke, all hospitalization costs will be analyzed per patient. All costs related to stroke in our hospital will be analyzed (surgery, clinical investigations, revalidation therapy etc) by our financial department.

Countries

Belgium

Contacts

Primary ContactDieter Mesotten, MD PhD
elly.vandermeulen@zol.be+3289325407
Backup ContactElly Vandermeulen, PhD
elly.vandermeulen@zol.be+3289325407

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026