Validation of DRAGON Versus a Simplified DRAGON/Machine Learning

NCT04092543 | Unknown

• 1 other identifier: DRAGON
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Acute

Keywords

CT-DRAGON score

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• PROMIS 10 questionnaire at 7 days after discharge

  7 days after discharge

• PROMIS 10 questionnaire at 90 days after the onset of stroke

  90 days after the onset of stroke

• NIHSS at 90 days after the onset of stroke

  90 days after the onset of stroke

• Analysis of the hospitalization cost after the onset of stroke

  90 days after the onset of stroke

Study Arms (1)

Stroke patients

All patients diagnosed with a stroke are collected in the database.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• all patients diagnosed with a stroke

Sponsors & Collaborators

• Ziekenhuis Oost-Limburg: lead
• University Hospital, Ghent: collaborator

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

RECRUITING

Related Publications (1)

• 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.

  PMID: 32849196 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• dieter Mesotten, MD PhD

  Ziekenhuis Oost-Limburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dieter Mesotten, MD PhD

CONTACT

+3289325407; elly.vandermeulen@zol.be

Elly Vandermeulen, PhD

CONTACT

+3289325407; elly.vandermeulen@zol.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: September 17, 2019
• Study Start: March 1, 2019
• Primary Completion: August 1, 2021
• Study Completion: November 1, 2021
• Last Updated: September 17, 2019

Record last verified: 2019-09

Locations

BE (1)