Multimodal Assessment of Frailty in Acute Stroke Patients
NCT ID: NCT06031909
Last Updated: 2023-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2023-08-01
2024-10-31
Brief Summary
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The main questions it aims to answer are:
1. How prevalent is frailty in patients with stroke?
2. Which impairments (e.g. undernutrion, impaired mobility, laboratory markers) contribute to frailty?
3. Is the outcome of frail patients worse than those without?
4. Are in-hospital complications more frequent in frail patients than those without?
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Detailed Description
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The aim of this study is to determine the prevalence of frailty in stroke patients at the Stroke Unit of the University Hospital Giessen and to analyze the associated characteristics and impacts on clinical outcomes. A multimodal frailty assessment will be conducted to capture a wide range of frailty features and investigate their significance. The study includes all stroke patients admitted to the certified stroke- unit of the University Hospital Giessen within a 3-month period. There are no inclusion criteria related to age, gender, or type of stroke.
The multimodal frailty assessment encompasses determining appropriate blood values (e.g., CRP, albumin), assessing muscle strength/mass through handheld dynamometry and sonographic muscle diameter, utilizing scores like the Clinical Frailty Scale (CFS) and the Groningen Frailty Indicator (GFI), evaluating nutritional status (BMI), collecting image-based frailty data (e.g., sarcopenia, cerebral white matter lesions, lacunar strokes, brain atrophy), and conducting suitable one-year follow-ups. Additionally, demographic and clinical data such as age, gender, type of stroke, and treatment details will be recorded.
The primary outcome is the prevalence of frailty among stroke patients. Secondary outcomes include the characteristics and impacts of frailty in stroke patients, including correlations between various frailty features and clinical outcomes such as length of hospital stay, mortality, and functional outcome.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Stroke patients
Stroke patients admitted to the certified stroke-unit of the Department of Neurology, University Hospital Giessen, Germany.
Multimodal frailty assessment
Different domains are assessed during hospital stay, these include:
* Clinical scores: Clinical Frailty scale (CFS), Groningen Frailty index (GFI)
* Brain frailty: assessing white matter hyperintensieties, atrophy and lacunar strokes in initial brain imaging
* Laboratory values: laboratory Frailty index (FI-Lab), inflammatory markers
* Nutrition: Controlling nutritional status score (CONUT-score), body mass index, dysphagia assessment (FOIS)
* Mobility/strengths: de Morton Mobility Index (DEMMI), grip strenghts of non-paralytic arm via dynamometer, muscle mass estimated by sonographic measurement of the biceps brachii muscle and the rectus femoris muscle.
Interventions
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Multimodal frailty assessment
Different domains are assessed during hospital stay, these include:
* Clinical scores: Clinical Frailty scale (CFS), Groningen Frailty index (GFI)
* Brain frailty: assessing white matter hyperintensieties, atrophy and lacunar strokes in initial brain imaging
* Laboratory values: laboratory Frailty index (FI-Lab), inflammatory markers
* Nutrition: Controlling nutritional status score (CONUT-score), body mass index, dysphagia assessment (FOIS)
* Mobility/strengths: de Morton Mobility Index (DEMMI), grip strenghts of non-paralytic arm via dynamometer, muscle mass estimated by sonographic measurement of the biceps brachii muscle and the rectus femoris muscle.
Eligibility Criteria
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Inclusion Criteria
* diagnosis of ischemic (including transient ischemic attack) or hemorrhagic stroke
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University of Giessen
OTHER
Responsible Party
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Stefan Gerner
Principal Investigator, Associate professor
Principal Investigators
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Stefan Gerner, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Neurology, University Hospital Giessen/Germany
Thorsten Doeppner, MD
Role: STUDY_CHAIR
Department of Neurology, University Hospital Giessen/Germany
Hagen Huttner, MD, PhD
Role: STUDY_CHAIR
Department of Neurology, University Hospital Giessen/Germany
Locations
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Department of Neurology, University Hospital Giessen
Giessen, Hesse, Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Giede-Jeppe A, Bobinger T, Gerner ST, Sembill JA, Sprugel MI, Beuscher VD, Lucking H, Hoelter P, Kuramatsu JB, Huttner HB. Neutrophil-to-Lymphocyte Ratio Is an Independent Predictor for In-Hospital Mortality in Spontaneous Intracerebral Hemorrhage. Cerebrovasc Dis. 2017;44(1-2):26-34. doi: 10.1159/000468996. Epub 2017 Apr 19.
Giede-Jeppe A, Reichl J, Sprugel MI, Lucking H, Hoelter P, Eyupoglu IY, Kuramatsu JB, Huttner HB, Gerner ST. Neutrophil-to-lymphocyte ratio as an independent predictor for unfavorable functional outcome in aneurysmal subarachnoid hemorrhage. J Neurosurg. 2019 Feb 1;132(2):400-407. doi: 10.3171/2018.9.JNS181975. Print 2020 Feb 1.
Gerner ST, Reichl J, Custal C, Brandner S, Eyupoglu IY, Lucking H, Holter P, Kallmunzer B, Huttner HB. Long-Term Complications and Influence on Outcome in Patients Surviving Spontaneous Subarachnoid Hemorrhage. Cerebrovasc Dis. 2020;49(3):307-315. doi: 10.1159/000508577. Epub 2020 Jul 3.
Related Links
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website of the recruiting site: Dpt. of Neurology, University Hospital Giessen
Other Identifiers
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AZ 220/21
Identifier Type: -
Identifier Source: org_study_id
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