Clinical trial NCT06031909: Multimodal Assessment of Frailty in Acute Stroke Patients
Official title: Multimodal Assessment of Frailty in Acute Stroke Patients Treated at a Certified Stroke-unit
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Frailty
Keywords: frailty
outcome
elderly
Lead sponsor: University of Giessen
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted with the diagnosis of acute stroke treated at the certified stroke-unit will be included. All patients who consent for participation are further eligible for the outcome assessment.

Brief summary: The goal of this study is to investigate the influence of frailty on clinical and stroke characteristics, treatment and outcomes in patients with acute stroke.

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?

Detailed description: Stroke is one of the most common causes of disability and mortality worldwide. A recognized complication in stroke patients is frailty, which is associated with increased costs, poorer prognosis, and higher mortality rates. However, there is currently no uniform definition or diagnostic criteria for frailty in stroke patients, and there is a need for standardized frailty assessments in this patient population.

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.

Eligibility criteria: Inclusion Criteria:

* treated at the certified stroke-unit of the Dpt. of Neurology, University Hospital Giessen
* diagnosis of ischemic (including transient ischemic attack) or hemorrhagic stroke

Exclusion Criteria:

* withdrawal of care within 24 hours after admission

Primary outcomes:
measure: Prevalence of frailty in stroke patients
timeFrame: 30 days
measure: Rate of good functional outcome
timeFrame: 12 months
Secondary outcomes:
measure: Patient reported outcome measures (PROM)
timeFrame: 12 months
measure: Functional impairment in activities of daily living
timeFrame: 12 months
measure: Mortality rate
timeFrame: From date of admission until death or last follow-up, whichever comes first, assessed up to 12 months.
measure: Cognitive outcome
timeFrame: 12 months
measure: Rate of rehospitalization
timeFrame: 12 months
measure: Major adverse cardiovascular events (MACE)
timeFrame: From date of admission until MACE or last follow-up, whichever comes first, assessed up to 12 months.
Other outcomes:
Locations:
city: Gießen
country: Germany
facility: Department of Neurology, University Hospital Giessen
state: Hesse
Study officials:
affiliation: Department of Neurology, University Hospital Giessen/Germany
name: Stefan Gerner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Neurology, University Hospital Giessen/Germany
name: Thorsten Doeppner, MD
role: STUDY_CHAIR
affiliation: Department of Neurology, University Hospital Giessen/Germany
name: Hagen Huttner, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.