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

Stroke Clinical Trial

— Denut_AVC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04830436
• Other study ID #: Denutrition_AVC2
• Status: Active, not recruiting
• Start date: March 31, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 248
• Est. completion date: December 31, 2023
• Est. primary completion date: May 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition
• Stroke

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint-Joseph	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

References & Publications (4)

Euronut - SENECA. Nutrition and the elderly in Europe. 1st European Congress on Nutrition and Health in the Elderly. The Netherlands, December 1991. Eur J Clin Nutr. 1991 Dec;45 Suppl 3:1-196. No abstract available. — View Citation

Unosson M, Ek AC, Bjurulf P, von Schenck H, Larsson J. Feeding dependence and nutritional status after acute stroke. Stroke. 1994 Feb;25(2):366-71. doi: 10.1161/01.str.25.2.366. — View Citation

Yoo SH, Kim JS, Kwon SU, Yun SC, Koh JY, Kang DW. Undernutrition as a predictor of poor clinical outcomes in acute ischemic stroke patients. Arch Neurol. 2008 Jan;65(1):39-43. doi: 10.1001/archneurol.2007.12. — View Citation

Zhang J, Zhao X, Wang A, Zhou Y, Yang B, Wei N, Yu D, Lu J, Chen S, Wang Y, Wang C, Xue R, Zhang Y, Li Y, Yu L, Wang S, Chen Z, Zheng T, Zhang Z, Xia M, He M, Li W, Zhang Z, Zeng F, Chen S, Fu Y, Liu G, Wang L, Huang Z, Ma J, Mu F, Xu Y, Huang R, Wang L, Wang Y. Emerging malnutrition during hospitalisation independently predicts poor 3-month outcomes after acute stroke: data from a Chinese cohort. Asia Pac J Clin Nutr. 2015;24(3):379-86. doi: 10.6133/apjcn.2015.24.3.13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical evolution of the patients: NIHSS	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.	Day 5
Primary	Modified Rankin Scale	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.	Month 3