Validation of DRAGON Versus a Simplified DRAGON/Machine Learning

Stroke, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04092543
• Other study ID #: DRAGON
• Status: Recruiting
• Start date: March 1, 2019
• Est. completion date: November 1, 2021

Study information

• Verified date: September 2019
• Source: Ziekenhuis Oost-Limburg
• Contact: Dieter Mesotten, MD PhD
• Phone: +3289325407
• Email: elly.vandermeulen[@]zol.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: November 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• all patients diagnosed with a stroke

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk

Sponsors (2)

Lead Sponsor	Collaborator
Ziekenhuis Oost-Limburg	University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Rankin Scale at day 90	The 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.	90 days after the onset of stroke
Primary	Modified Rankin Scale at 7 days after discharge	The 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.	7 days after discharge at the hospital
Secondary	PROMIS 10 questionnaire at 7 days after discharge	The 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.	7 days after discharge
Secondary	PROMIS 10 questionnaire at 90 days after the onset of stroke	The 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.	90 days after the onset of stroke
Secondary	NIHSS at 90 days after the onset of stroke	Change 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.	90 days after the onset of stroke
Secondary	Analysis of the hospitalization cost after the onset of stroke	90 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.	90 days after the onset of stroke