Denut_AVC: Impact of Undernutrition in Patients Over 70 Years of Age Thrombolysed and/or Thrombectomized for Stroke

Sponsor
Groupe Hospitalier Paris Saint Joseph (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04830436
Collaborator
(none)
248
1
21
11.8

Study Details

Study Description

Brief Summary

Undernutrition is a frequent problem in hospitals (at least 30% of patients, SENECA-NHANES studies). Its impact on morbidity and mortality is well known in gerontology, oncology and intensive care. There are very few neurovascular studies dealing with the consequences of undernutrition present before the stroke. Indeed, most of the medical literature concerns only undernutrition acquired after a stroke. The investigator propose to analyze medical data from a cohort of patients over 70 years of age thrombolysed and/or thrombectomized in the neurovascular department between the years 2014 and 2019.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    248 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Analysis of the Impact of Undernutrition in Patients Over 70 Years of Age Thrombolysed and/or Thrombectomized for Stroke
    Actual Study Start Date :
    Mar 31, 2021
    Actual Primary Completion Date :
    May 4, 2021
    Anticipated Study Completion Date :
    Dec 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Clinical evolution of the patients: NIHSS [Day 5]

      This outcome correspond to the National Institute of Health Stroke Score (NIHSS) at day 5. The score is 0: No stroke symptoms; 1-4: Minor stroke; 5-15: Moderate stroke; 16-20: Moderate to severe stroke; 21-42 : Severe stroke.

    2. Modified Rankin Scale [Month 3]

      The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Rankin scale: 0 - No symptoms. - No significant disability. Able to carry out all usual activities, despite some symptoms. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. - Moderate disability. Requires some help, but able to walk unassisted. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. - Dead.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    70 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients over 70 years of age with cerebral infarction, thrombolysed and/or thrombectomized between 2014 and 2019, managed in the Neurology and Neurovascular Department of the Paris Saint-Joseph Hospital

    • French-speaking patient

    Exclusion Criteria:
    • Patients with non-thrombolyzed stroke

    • Patient with a TIA (Transient Ischemic Attack)

    • Patient under guardianship or curatorship

    • Patient deprived of liberty

    • Patient under court protection

    • Patients who object to the use of their data for this research

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Groupe Hospitalier Paris Saint-Joseph Paris France 75014

    Sponsors and Collaborators

    • Groupe Hospitalier Paris Saint Joseph

    Investigators

    • Principal Investigator: Marie Bruandet, MD, Groupe Hospitalier Paris Saint Joseph

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Groupe Hospitalier Paris Saint Joseph
    ClinicalTrials.gov Identifier:
    NCT04830436
    Other Study ID Numbers:
    • Denutrition_AVC2
    First Posted:
    Apr 5, 2021
    Last Update Posted:
    Jun 30, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 30, 2022