Construction of a Multidimensional Score for the Functional Prognosis of Cerebral Infarctions

NCT04802772 | Unknown

• 1 other identifier: ICDIM 1
• Study Type: observational
• Target: 2,091
• Locations: 1 country
• Sites: 1

Brief Summary

In France, stroke is the leading cause of non-traumatic acquired motor disability in adults, the second leading cause of major cognitive impairment, and the third leading cause of death in men and women. The average age of onset is 73 years (70 years for men, 76 years for women). All types combined, approximately 100,000 patients are hospitalized for stroke each year, approximately 40,000 people die and 30,000 have serious after-effects at one year. The spectrum of functional sequelae ranges from motor and sensory impairment to cognitive impairment; moreover, 30 to 50% of patients have a recurrence within 5 years. Data from the Dijon Stroke Registry showed in 2011 that only 36% of people who had a stroke between 2000 and 2009 were symptom-free 1 month after the event; 22% of patients had mild or moderate disability according to the modified Rankin Scale (mRS); and 42% were unable to walk without assistance or had died. Based on 2009 self-reported data, more than one in two (51%) of those with a history of stroke with sequelae reported significant difficulty or inability to walk 500 meters; 45% had difficulty with at least one activity of daily living. The mortality rate was 44.7 per 100 000 persons in 2013. Cerebral infarctions (CIs) account for the majority of strokes (70-75%). In 2014, despite a 12.5% decrease from 2008, hospital case fatality for CIs remained high at 9%. In 2015, the case fatality rate was 10.7% at 30 days and 11.9% at 1 year. Thirty-day mortality alone concentrated nearly half (47%) of the 1-year mortality.

Conditions

Cerebral Infarction

Keywords

multidimensional score

Outcome Measures

Primary Outcomes (2)

• To construct a multidimensional ICDIM 1 score predictive of the functional prognosis of patients at discharge from a hospitalization motivated by a CI

  Comparison of observed correlations between ICDIM 1 and the change in mRS score before hospitalization and its value assessed at discharge adjusted for length of stay

  Up to 6 months

• Compare the performance of the artificial intelligence-based ICDIM 1 score with the performance of the NIHSS reference score

  Comparison of the observed correlations between the NHISS score and this same change in the mRS score

  Up to 6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Major patients hospitalized in the Neurology-Neurovascular department of GHPSJ and discharged from hospitalization between January 1, 2016 and September 25, 2020.

You may qualify if:

• Major patients hospitalized in the Neurology-Neurovascular department of GHPSJ and discharged from hospital between January 1, 2016 and September 25, 2020.
• Main diagnosis (MD) of CI retained by the MISP (Medicalization of Information Systems Program) grouping algorithm for the SSS (Standardized summary of stay) and defined according to the codes of the chapter "Cerebral Infarction": I63.0 to I63.5 and I63.7 to I63.9 of the ICD-10 (International Classification of Diseases, 10th revision)
• Patients hospitalized in the NICU and for whom the passage to the NICU is the first hospitalization unit from their home or the hospitalization unit that follows a passage to the emergency department/ emergency door beds/short-term hospitalization unit (STHU)
• Length of stay greater than or equal to 3 nights

You may not qualify if:

• Patient under guardianship or curatorship
• Patient deprived of liberty
• Patient under legal protection
• Patient objecting to the use of his/her data for this research
• SSS with MD I63.6 (CI due to cerebral venous thrombosis, non-pyogenic)
• Length of stay less than or equal to 2 nights
• Patients from other GHPSJ hospitalization units (excluding emergency department emergency, emergency door beds or STHU), or from an external establishment
• SSS with a MD I63.0 to I63.5 or I63.7 to I63.9 not involving a passage in the NICU
• SSS with a MD I63.0 to I63.5 or I63.7 to I63.9 involving a visit to a NICU that is neither the first hospitalization unit from home nor the hospitalization unit that follows a visit to the emergency department / emergency door beds/short-term hospitalization unit

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint-Joseph

Paris, Île-de-France Region, 75014, France

Location

MeSH Terms

Conditions

Cerebral Infarction

Condition Hierarchy (Ancestors)

Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Virginie BOURSIER

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Virginie BOURSIER

CONTACT

01 44 12 33 33; vboursier@ghpsj.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 17, 2021
• Study Start: April 30, 2023
• Primary Completion: April 30, 2024
• Study Completion: December 31, 2024
• Last Updated: March 7, 2023

Record last verified: 2023-03

Locations

FR (1)