Validation of DRAGON Versus a Simplified DRAGON/Machine Learning
16. september 2019 opdateret af: Dieter Mesotten, Ziekenhuis Oost-Limburg
Prediction of Outcome After Acute Stroke: Validation of CT-DRAGON Versus a Simplified CT-DRAGON Score
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.
Studieoversigt
Status
Ukendt
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
700
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Genk, Belgien, 3600
- Rekruttering
- Ziekenhuis Oost-Limburg
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Kontakt:
- Ziekenhuis Oost-Limburg
- Telefonnummer: 03289325407
- E-mail: elly.vandermeulen@zol.be
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
All patients diagnosed with a stroke will be analyzed in the database starting from March 1, 2019 until August 1 2021
Beskrivelse
Inclusion Criteria:
- all patients diagnosed with a stroke
Exclusion Criteria:
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Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Stroke patients
All patients diagnosed with a stroke are collected in the database.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Modified Rankin Scale at day 90
Tidsramme: 90 days after the onset of stroke
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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.
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90 days after the onset of stroke
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Modified Rankin Scale at 7 days after discharge
Tidsramme: 7 days after discharge at the hospital
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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.
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7 days after discharge at the hospital
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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PROMIS 10 questionnaire at 7 days after discharge
Tidsramme: 7 days after discharge
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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.
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7 days after discharge
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PROMIS 10 questionnaire at 90 days after the onset of stroke
Tidsramme: 90 days after the onset of stroke
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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.
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90 days after the onset of stroke
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NIHSS at 90 days after the onset of stroke
Tidsramme: 90 days after the onset of stroke
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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.
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90 days after the onset of stroke
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Analysis of the hospitalization cost after the onset of stroke
Tidsramme: 90 days after the onset of stroke
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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.
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90 days after the onset of stroke
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: dieter Mesotten, MD PhD, Ziekenhuis Oost-Limburg
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. marts 2019
Primær færdiggørelse (Forventet)
1. august 2021
Studieafslutning (Forventet)
1. november 2021
Datoer for studieregistrering
Først indsendt
14. august 2019
Først indsendt, der opfyldte QC-kriterier
16. september 2019
Først opslået (Faktiske)
17. september 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. september 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. september 2019
Sidst verificeret
1. september 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- DRAGON
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
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