StrokeDenut_AVCNCT04830436
Impact of Undernutrition in Patients Over 70 Years of Age Thrombolysed and/or Thrombectomized for Stroke
An observational study of Stroke, run by Fondation Hôpital Saint-Joseph at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Stroke
- How many people
- 248 participants
- Where
- 1 siteFrance
- Study dates
- 31 Mar 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients hospitalized for cerebral infarction who received thrombolysis and/or thrombectomy treatment between 2014 and 2019
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of the Impact of Undernutrition in Patients Over 70 Years of Age Thrombolysed and/or Thrombectomized for Stroke
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.
- Conditions
- Stroke
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 5
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.
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start31 Mar 2021
- Primary completion4 May 2021
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie Bruandet, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04830436
- Sponsor's protocol ID
- Denutrition_AVC2
- Acronym
- Denut_AVC
- Status last verified
- Apr 2023
- First submitted
- 31 Mar 2021
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26420177Yoo 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.
PubMed 18195138Unosson 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.
PubMed 8303747Euronut - 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.
PubMed 1687315
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Impact of Undernutrition in Patients Over 70 Years of Age Thrombolysed and/or Thrombectomized for Stroke
- ClinicalTrials.gov ID
- NCT04830436
- Acronym / sponsor ID
- Denut_AVC / Denutrition_AVC2
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 4 May 2021 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 5 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients hospitalized for cerebral infarction who received thrombolysis and/or thrombectomy treatment between 2014 and 2019
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical evolution of the patients: NIHSS
Time frame: 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.
Modified Rankin Scale
Time frame: 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. 1. - No significant disability. Able to carry out all usual activities, despite some symptoms. 2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. - Moderate disability. Requires some help, but able to walk unassisted. 4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. - Dead.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Background: PubMed 26420177Zhang 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.
- Background: PubMed 18195138Yoo 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.
- Background: PubMed 8303747Unosson 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.
- Background: PubMed 1687315Euronut - 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie Bruandet, MD principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Fondation Hôpital Saint-Joseph at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical evolution of the patients: NIHSS (time frame: Day 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04830436, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.